Associate Director RA & QA

DEA Manager

EHS Manager

Specification Sales Engineer, Low Voltage System Assemblies

Logistics Analyst

Sr. Application Developer

Manager II – Manufacturing & Process Development Engineering

VP,  Senior Audit Manager

VP, IAM Assurance Leader

AVP, IAM Program Manager

Role Description: <ul><li>The Associate Director – Regulatory Affairs (CA) will lead the development and execution of regulatory strategies to support the timely approval, lifecycle management, and commercialization of generic pharmaceutical products in Canada. </li><li>The role will focus heavily on Abbreviated New Drug Submissions (ANDS) and Supplemental ANDS filings, while acting as the primary interface with Health Canada for regulatory discussions, clarifications, and negotiations.</li><li>This position plays a critical strategic role in new product development, portfolio expansion, and in-licensing evaluation, ensuring all regulatory activities align with Health Canada requirements, corporate objectives, and market access timelines.</li><li>The Director will also support portfolio maximization (PMX) initiatives, identify regulatory opportunities, and oversee a small regulatory team.</li></ul> Responsibilities: Regulatory Strategy &amp; Leadership <ul><li>Develop and implement regulatory strategies for ANDS submissions to Health Canada that maximize probability of approval and accelerate time to market.</li><li>Provide strategic regulatory guidance during product selection and development phases, including formulation, bioequivalence, and labeling strategy.</li><li>Ensure regulatory considerations are integrated into R&amp;D, clinical, CMC, and commercial planning.</li><li>Advise senior leadership on Canadian regulatory landscape, evolving guidelines, and approval pathways.</li><li>Lead regulatory planning for first-to-file, complex generics, and niche opportunities where applicable.</li></ul> Health Canada Engagement &amp; Regulatory Submissions <ul><li>Serve as the primary liaison with Health Canada, maintaining professional and proactive relationships with regulatory authorities.</li><li>Lead preparation and submission of: o Abbreviated New Drug Submissions (ANDS)</li><li>Supplemental ANDS (SANDS)</li><li>Notifiable Changes</li><li>Post-approval regulatory filings</li><li>Manage Health Canada deficiency responses, clarification requests, and review cycles.</li><li>Coordinate cross-functional teams to ensure high-quality regulatory dossiers</li><li>Represent the company in Health Canada meetings, scientific advice discussions, and regulatory negotiations.</li><li>Track and interpret Health Canada guidance updates, policy changes, and regulatory precedents affecting generic drug approvals.</li></ul> In-Licensing &amp; Regulatory Due Diligence <ul><li>Conduct regulatory due diligence for potential in-licensing and partnership opportunities.</li><li>Evaluation of regulatory pathways and submission feasibility</li><li>Data package completeness</li><li>Bioequivalence strategy</li><li>Intellectual property and exclusivity considerations</li><li>Estimated approval timelines and risks</li><li>Provide regulatory risk assessments and strategic recommendations to senior management during deal evaluation.</li><li>Support technology transfer and regulatory integration of licensed products into the company’s Canadian portfolio.</li></ul> Portfolio Management &amp; Lifecycle Optimization <ul><li>Support portfolio maximization (PMX) initiatives, including o Label expansions</li><li>New strengths and dosage forms</li><li>Site transfers</li><li>Manufacturing changes</li><li>Competitive lifecycle strategies</li><li>Identify regulatory opportunities to extend product lifecycle or improve market competitiveness.</li><li>Partner with commercial, market access, and supply chain teams to align regulatory activities with business objectives.</li></ul> Cross-Functional Collaboration <ul><li>Work closely with internal teams including o R&amp;D / Formulation Development</li><li>Clinical &amp; Bioequivalence</li><li>Quality Assurance / Quality Control</li><li>CMC / Manufacturing</li><li>Intellectual Property</li><li>Business Development</li><li>Provide regulatory input during product development milestones and technical reviews.</li><li>Ensure regulatory compliance with Health Canada, ICH, and global regulatory standards.</li></ul> Team Leadership &amp; Development <ul><li>Lead, mentor, and develop 1–3 regulatory associates/managers.</li><li>Oversee work allocation, submission timelines, and performance development.</li><li>Build a high-performance regulatory function capable of managing increasing submission volume.</li><li>Promote a culture of accountability, quality, and regulatory excellence.</li></ul> Requirements: Education &amp; Experience <ul><li>Advanced degrees in Pharmacy, Life Sciences, Pharmacology, Regulatory Affairs, or related discipline.</li><li>Regulatory certification (e.g., RAC) is considered an asset.</li><li>15–20 years of regulatory affairs experience within the pharmaceutical industry.</li><li>Extensive experience with Canadian regulatory submissions, particularly:</li><li>ANDS</li><li>SANDS</li><li>eCTD filings</li><li>Demonstrated experience interacting directly with Health Canada.</li><li>Strong understanding of Generic drug approval pathways</li><li>Bioequivalence requirements</li><li>CMC regulatory expectations</li><li>Experience supporting business development or in-licensing regulatory evaluations.</li><li>Previous team leadership or mentoring experience preferred.</li></ul> Core Competencies <ul><li>Strategic Thinking Ability to translate regulatory requirements into business-focused strategies that accelerate approvals and strengthen the company’s competitive position.</li><li>Regulatory Expertise Deep knowledge of Health Canada regulatory frameworks, ANDS requirements, and generic drug approval processes.</li><li>Stakeholder Influence Proven ability to engage effectively with regulatory authorities, internal leadership, and external partners</li><li>Physical Requirements</li></ul> Physical &amp; mental requirements: <ul><li>Business travel (15% of time), driving as part of work responsibilities.</li></ul>

Role Description: <ul><li>The DEA Manager is responsible for ensuring the company maintains strict compliance with all DEA regulations and applicable state-level controlled substance laws.</li><li>This role manages the day-to-day requirements for handling-controlled substances, including quota management, licensing, ARCOS reporting, Suspicious Order Monitoring (SOM), material movement, and maintaining accurate records to ensure audit readiness at all times.</li></ul> Responsibilities: <ul><li>Manages a team supporting State Licensing, Suspicious Order Monitoring (SOM) and DEA.</li><li>Manages and submits DEA procurement quota applications.</li><li>Maintains and renews DEA, State, and Board of Pharmacy licenses and registrations for all company facilities.</li><li>Oversees the generation and execution of DEA 222 forms for the transfer and procurement of Schedule II controlled substances.</li><li>Acts as the primary point of contact during DEA and State Board of Pharmacy inspections and audits.</li><li>Liaises with Procurement and the DEA regarding the import/export of control substances and completes required documentation.</li><li>Prepares, reviews, and submits accurate and timely ARCOS reports to the DEA; Ensures accurate reporting of year-end and biennial inventories across all facilities.</li><li>Conducts internal audits of controlled substance vaults, cages, and manufacturing areas to ensure physical security and record-keeping compliance.</li><li>Drafts, reviews, and updates Standard Operating Procedures (SOPs) related to the handling, storage, and distribution of controlled substances.</li><li>Monitors federal and state legislative changes regarding controlled substances; advises management on the impact of new regulations and implement necessary operation shifts.</li><li>Coordinates all controlled substance destruction with the warehouse and the Environmental, Health &amp; Safety department.</li></ul> Requirements: Education &amp; Experience <ul><li>Bachelor’s degree in science, PharmD preferred.</li><li>5+ years of relevant work experience.</li><li>Strong knowledge of DEA and FDA regulations.</li></ul> Physical Requirements <ul><li>Ability to stand, walk, or climb stairs/ladders for extended periods while performing duties within the plant.</li><li>Occasional lifting or moving of materials or equipment (generally up to 25–40 lbs)</li><li>Frequent use of hands and eyes for computer work, and documentation.</li><li>Ability to wear required personal protective equipment (PPE) such as safety glasses, gowns, gloves, or respirators when entering manufacturing areas.</li><li>Capacity to work in cleanroom, environments, which may involve temperature variations, or noise.</li><li>Must be able to travel between facilities as needed</li></ul>

Responsibilities: EHS Strategy &amp; Leadership: <ul><li>Develop, implement, and maintain a comprehensive EHS management system aligned with company goals and regulatory requirements.&nbsp;</li><li>Integrate EHS strategy into broader business planning and participate in leadership meetings to influence decision-making.&nbsp;</li><li>Lead change management initiatives to build a proactive safety culture across all levels of the organization.</li></ul> Risk Management &amp; Compliance: <ul><li>Conduct and advise on risk assessments, quantify and prioritize risks, and implement effective control measures.&nbsp;</li><li>Ensure compliance with OSHA, EPA, and other relevant local, state, and federal regulations.&nbsp;</li><li>Oversee contractor and visitor safety programs, including onboarding and compliance tracking.</li></ul> Training &amp; Engagement: <ul><li>Design and deliver engaging EHS training programs tailored to various roles and risk profiles.&nbsp;</li><li>Promote employee engagement through behavior-based safety (BBS), ergonomics, and wellness initiatives.&nbsp;</li><li>Champion inclusive safety practices that consider diverse employee needs and backgrounds.</li><li>Emergency Preparedness &amp; Crisis Management: Develop and maintain emergency response plans, conduct drills, and coordinate with local emergency services.&nbsp;</li><li>Lead crisis management efforts, including communication protocols and post-incident reviews.</li></ul> Environmental Sustainability: <ul><li>Implement and monitor environmental sustainability programs, including waste reduction, energy efficiency, and water conservation.</li><li>Audits, Inspections &amp; Continuous Improvement: Conduct regular audits and inspections to identify hazards and ensure compliance.&nbsp;</li><li>Use data analytics and digital tools to track performance, identify trends, and drive continuous improvement.</li><li>Hazardous Materials &amp; Waste Management: Oversee safe handling, storage, and disposal of hazardous chemicals and waste.&nbsp;</li><li>Ensure proper documentation and training related to chemical safety and spill containment.</li></ul> Requirements: <ul><li>Bachelor’s degree in Environmental Science, Occupational Safety, Industrial Engineering, or related field</li><li>7+ years’ experience, including 2+ years of progressive people management experience - (equivalent experience may be considered).</li><li>Proven experience in chemical handling, technical operations, and regulatory compliance.</li><li>Strong knowledge of OSHA, EPA, ISO standards, and other applicable regulations.</li><li>Proficiency in EHS software platforms and data analytics tools. Demonstrated leadership, communication, and team-building skills.</li><li>Ability to manage projects, influence cross-functional teams, and drive cultural transformation.</li></ul>

Role Description: <ul><li>Specification Sales Engineer, Low Voltage System Assemblies What you’ll do: As a Specification Engineer, you will have the opportunity to align your skills, interests, and aspirations with a role that allows you to define your own goals.</li><li>You will be responsible for expanding and maintaining a network of specifying entities—such as engineering offices, consultants, and end-users—ensuring the company is involved early in the project lifecycle.</li><li>You will influence specifications, track project sources, and ensure internal alignment to maximise opportunity conversion and solution adoption.</li></ul> Responsibilities: <ul><li>Prospecting: Identify new specifying entities and early-stage projects through proactive research and outreach.Building Relationships with Priority Specifying Entities: Cultivate long-term relationships with consultants, engineers, and end-users to influence project direction.</li></ul> <ul><li>Planning Account Actions: Develop account-specific strategies to drive specification success and long-term engagement.</li></ul> <ul><li>Planning Calls: Prepare and schedule impactful calls with specifying entities to uncover and advance project opportunities.</li></ul> <ul><li>Conducting Discovery: Gather detailed insights into customer needs, project requirements, and decision-making processes.</li></ul> <ul><li>Planning Opportunities: Align internal resources and timelines to capitalise on identified project opportunities.</li></ul> <ul><li>Drafting Initial Concepts: Create early-stage technical and commercial proposals tailored to project specifications.</li></ul> <ul><li>Transferring Descriptive Concepts to Backend: Ensure smooth handover of project concepts to internal teams for execution and follow-up.</li></ul> <ul><li>Making Bid or No Bid Decisions: Evaluate project fit and strategic value to determine pursuit strategy.</li></ul> <ul><li>Communicating with Internal Stakeholders: Coordinate with Project Sales Engineers, back office, and project management to ensure project continuity.</li></ul> Requirements: <ul><li>Educational Background: Bachelor’s or Master’s degree in Electrical Engineering, or justifiable equivalent education.</li><li>Previous Experience: 2–5 years of experience.</li><li>Required Languages: English &amp; Turkish</li></ul>

Responsibilities: <ul><li>Maintain &amp; report KPIs related to Freight, Duty, Warehousing, and Inventory to drive stakeholder engagement &amp; action.</li><li>Act as a liaison between regional supply chain leaders, Global Logistics, and Finance to collect known headwinds, tailwinds, and cost reduction projects for inclusion in the quarterly consensus forecast</li><li>Track attainment to forecast every month, including Pareto analysis of any misses &amp; gap closure plan</li><li>Challenge existing targets &amp; identify opportunities for further improvements by partnering with the Global Logistics &amp; Global Trade Services organizations</li><li>Drive adherence &amp; standardization in the Premium Freight approval workflow, including training, specific guidelines for customer liability, and data input and reconciliation at the regional level</li><li>Identify and lead a project(s) that directly contributes to freight and/or duty cost reduction</li><li>Develop guidelines for inventory stocking strategy (Make-To-Stock / Make-To-Order), Safety Stock, Lot Sizes</li><li>Collaborate with the Master Data team to review and maintain system parameters in accordance with the latter.</li><li>Lead Slow-Moving / Obsolete inventory cadence &amp; drive actions to completion, including End-of-Life procedure</li><li>Integrate with Corporate initiatives for inventory optimization (ABC/FMR, Healthy Stock methodology)</li><li>Create innovation and digitize reports for better data presentation and action determination.</li></ul> Requirements: <ul><li>Bachelors degree in Supply Chain Management, Business Administration, Information Systems, or a related field. A Masters degree is preferred.</li><li>Proven experience 5+ years in master data management, data governance, or a related field, preferably in a supply chain planning environment.</li><li>Strong knowledge of supply chain planning processes, including demand planning, inventory management, and production planning.</li><li>Proficiency in utilizing master data management tools and systems (e.g., SAP MDG, Informatica MDM, etc.).</li><li>Solid understanding of data governance principles, data quality management, and data lifecycle management.</li></ul>

Responsibilities: <ul><li>Design, develop, and maintain web applications using Java, Spring Boot, React, Redux, and PostgreSQL</li><li>Implement and manage APIs and microservices architecture</li><li>Ensure the performance, quality, and responsiveness of applications</li><li>Identify and correct bottlenecks and fix bugs</li><li>Partner with business stakeholders and operations team to identify and manage KPIs</li><li>Evaluate the performance of processes, services, and outcomes and drive performance improvement</li><li>Independently solve complex issues, lead a team of junior and mid-level developers</li><li>Other duties as assigned</li></ul> Requirements: <ul><li>Bachelor’s degree in computer science, Information Technology, or related field. Minimum of 12-15 years offull stack development related work experience</li><li>Strong oral and written communication skills</li><li>Expert in Java, Spring Boot, React, Redux, and PostgreSQL</li><li>Strong analytical skills with the ability to collect, organize, and analyze data</li><li>Attention to detail and accuracy is critical</li><li>Working knowledge of cloud platforms (e.g., AWS, Azure)</li><li>Adept at presenting findings in MS PowerPoint and MS Word</li></ul>

Responsibilities: Lead a team of engineers who will: <ul><li>Develop power connector assembly manufacturing process in accordance with LEANPD product development.</li><li>Drive for excellence in existing manufacturing technologies and methods.</li><li>Strive to implement new manufacturing technologies to provide improved process and tolerance control.</li><li>Support Product Development in the optimization designs (DFM) and piece parts for manufacturability; realizes sample tooling, product samples, and prototypes.</li><li>Design, develop, and qualify tooling and processes to meet company DDN quality and production standards.</li><li>Support the supply chain to verify supplier compliance and capability.</li><li>Act as the binding element between product development and manufacturing engineering, ensuring the effectiveness and efficiency of this critical interface.</li><li>Maintain communication with the project management team to understand current and future strategic business needs</li><li>Prioritize and time manage a portfolio of projects/work efforts based on criticality and business need</li><li>Provide readouts to Senior manager and Director-level cross-functional management as necessary</li><li>Work with the Philippines operations team to assign resources necessary for the successful execution of new product development</li><li>Facilitate and coordinate cross-functional communication across globally matrixed organizations</li></ul> Requirements: <ul><li>Bachelors or above degree with mechanical/electrical related majors.</li><li>At least 5 years of managerial-level experience related to a multinational manufacturing site.</li><li>Familiar with Lean, Six Sigma. etc. industrial methods/tools.</li><li>With 2 years or above work experience in the connector assembly industry is preferred.</li><li>Fluent in English and good presentation skills.</li><li>Familiar with MS software.</li><li>Familiar with industrial specification (i.e., IPC 620).</li><li>Familiar with Stamping / Plating / Molding / Assembly processes</li></ul>

Responsibilities: <ul><li>Engage with India Leadership to understand emerging risk while providing risk themes and trends that can inform and help improve governance and control awareness.</li><li>Provide IA leadership to the Internal Audit team based in India by motivating and developing individuals to elevate quality and expand capabilities.</li><li>Assist with continuous monitoring activities related to Technology.</li><li>Supervise, manage, and motivate Audit Managers on scheduled audits.</li><li>Oversee audit planning and execution of audits including audit scoping, setting audit objectives, defining audit test steps, performing audit fieldwork and drafting audit reports.</li><li>Review and provide feedback to Audit Managers on the documentation of detailed process walkthroughs performed with management, including the identification of process risks and controls.</li><li>Review and provide feedback on detailed audit work papers performed during fieldwork, including control design and effectiveness testing.</li><li>Ensure Audit Managers have developed and documented clear audit work papers that succinctly articulate the process, risks, controls, test work performed, and conclusions reached.</li><li>Ensure effective and efficient execution of audits in conformance with professional and department quality standards.</li><li>Identify and articulate control gaps or control deficiencies.</li><li>Ensure timeliness of audit work and ensure audit is performed within budget.</li><li>Present audit results to various levels of internal audit leadership, as well as the business organization.</li><li>Contribute to risk assessment process and ongoing business/industry monitoring.</li><li>Maintain internal audit competency through ongoing professional development.</li><li>Oversee career and professional development of direct reports.</li><li>Perform other duties and/or special projects as assigned.</li></ul> Requirements: <ul><li>Bachelors or advanced degree in technology, business, or finance, with a minimum of 10+ years of relevant experience working within audit or a risk management function or minimum 12+ years relevant experience in lieu of a degree</li><li>Bachelor’s degree in Accounting, Auditing, or a technology-related degree with 9+ years of audit experience</li><li>5+ years in technology audit, controls, operations, and/or compliance</li><li>2+ years recent experience managing, supervising, and mentoring individuals</li><li>2+ years recent experience in leading projects and motivating teams</li><li>CISA/CISM/CPA/CIA/CRISC/CISSP certifications</li><li>Ability and flexibility to travel for business as required</li></ul>

Responsibilities: <ul><li>Create and Maintain Strategic Roadmaps: Develop and execute multi-year roadmaps to drive innovation, strengthen security posture, meet regulatory requirements, and streamline IAM operations—specifically for IAM assurance capabilities, control monitoring, and evidence automation.</li><li>Stakeholder Engagement: Build and nurture strong relationships across Security Operations, Technology Teams, Governance, Operational Risk, and Internal Audit, ensuring program alignment, audit readiness, and the ability to clearly demonstrate IAM control effectiveness to stakeholders and regulators.</li><li>Risk and Progress Management: Identify, assess, and mitigate technical and organizational risks while regularly reporting blockers, corrective actions, and program milestones to executive leadership; ensure timely remediation of control gaps and recurring defects.</li><li>Solution Design &amp; Automation: Lead and contribute to designing technical solutions for complex automation use cases, driving operational efficiency and scalability—especially automation to detect, track, and remediate IAM control defects.</li><li>Program Integrity: Ensure standards, policies, and procedures are accurately documented and officially maintained for audit and compliance requirements; recommend updates to IAM standards based on security threats, regulatory expectations, and industry trends.</li><li>Performance Tracking: Define, implement, and monitor Key Risk Indicators (KRIs) and Key Performance Indicators (KPIs) to measure program maturity and overall effectiveness, including assurance coverage, control pass rates, remediation SLAs, defect recurrence, and reporting timeliness/accuracy.</li><li>Assurance Operations Leadership: Lead assurance activities to track, validate, and remediate key logical access and authentication controls across centralized IAM services (e.g., Active Directory, Oracle LDAP, Beyond Identity) and decentralized implementations as applicable.</li><li>Assurance Reporting Platform Ownership: Manage and evolve the IAM assurance reporting platform(s) used to monitor adherence to company standards, control design, and operational effectiveness; ensure reporting is accurate, resilient, and audit-ready.</li><li>Agile Partnership with Product Owners: Partner with IAM product owners and delivery teams using Agile methodologies to prioritize and implement control improvements, balancing risk reduction with service stability and customer impact.</li><li>Control Evidence &amp; Audit Support: Ensure the organization can efficiently produce high-quality evidence for SOX, PCI, and other examinations; proactively address audit issues with root-cause correction and sustainable control improvements.</li><li>Documentation &amp; Enablement: Oversee creation, maintenance, and review of operational process documentation and end-user/training materials needed to support consistent execution of IAM assurance activities.</li><li>Problem Resolution: Independently resolve technical challenges while escalating issues with clarity when necessary.</li><li>Perform other critical duties or special projects as assigned.</li></ul> Requirements: <ul><li>BS/BA in Computer Science, Information Technology, Cybersecurity, Business Management, or equivalent, plus 10+ years IT experience, OR in lieu of a degree with 12+ years IT experience demonstrating progressive responsibility.</li><li>Minimum 5 years of experience leading multiple IAM service products (e.g., authentication, privileged access, identity governance) and driving outcomes across both centralized and distributed service models.</li><li>Minimum 5 years of experience developing and improving IAM service processes and reporting on IAM service key controls (design and operating effectiveness).</li><li>Minimum 3 years leading operations or assurance teams, including continuous monitoring, issue management, and control remediation.</li><li>At least 2 years working with Agile methodologies in roles such as Product Owner, Scrum Master, or Technical Lead.</li><li>Minimum 2 years of people management experience, leading teams of 2+ engineers or contractors.</li></ul>

Responsibilities: <ul><li>Support critical IAM programs; coordinate cross-functionally with IAM teams, Information Security teams and business IT stakeholders to manage the successful delivery of IAM projects</li><li>Deliver on suitable short-term and long-term strategic objectives</li><li>Drive and deliver program issues/risks and resolution, decision logs, communication plans and other program documentation to ensure project goals are achieved and audit traceability is in place</li><li>Engage regularly with key stakeholders on issues/risk and decisions and gather feedback on implementation of solutions impacting the organization</li><li>Establish and support program metrics and evaluation methods to assess program strengths and identify areas for improvement as well as timely reporting of program status throughout its life cycle</li><li>Prepare and present reports for program sponsors and leadership</li></ul> Requirements: <ul><li>Bachelor’s degree or equivalent experience; technology or equivalent related field preferred, with a minimum of 6 years of experience in Information Technology OR in lieu of the Bachelors degree, a minimum of 8 years of experience in Information Technology</li><li>Minimum of 5 years of experience managing large scale, cross functional project</li><li>Minimum of 5 years of experience in information technology, with a focus on information security in one or more of the following areas: IAM, security operations, security architecture, policy/governance</li><li>Minimum of 4 years of experience supporting auditors, audit inquiries and ad-hoc reporting</li><li>Solid management skills</li><li>Experience with metrics for assessing and reporting program progress, productivity and variance analysis</li><li>Strong problem solving skills</li><li>Strong oral and written communication (presentation) skills</li><li>Program Management Certified (PMP) preferred</li></ul>

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206 senior solution architect life science Jobs found

Associate Director RA & QA

DEA Manager

EHS Manager

Specification Sales Engineer, Low Voltage System Assemblies

Logistics Analyst

Sr. Application Developer

Manager II – Manufacturing & Process Development Engineering

VP, Senior Audit Manager

VP, IAM Assurance Leader

AVP, IAM Program Manager

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206 senior solution architect life science Jobs found

Associate Director RA & QA

DEA Manager

EHS Manager

Specification Sales Engineer, Low Voltage System Assemblies

Logistics Analyst

Sr. Application Developer

Manager II – Manufacturing & Process Development Engineering

VP, Senior Audit Manager

VP, IAM Assurance Leader

AVP, IAM Program Manager

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow is on a mission to connect companies with the best talent across the globe.