Associate Director RA & QA

S & OE Manager

QMS – Sr Quality & Reliability Engg

EHS Manager

HR Systems and Workforce Analyst

Specification Sales Engineer, Low Voltage System Assemblies

Customer Service Specialist

Sr. Application Developer

Assistant Manager, SC Projects

Document Controller

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>

Responsibilities: Factory S&amp;OE Execution Ownership: <ul><li>Own S&amp;OE execution across 4 manufacturing sites, ensuring alignment between demand, supply, and production plans</li><li>Drive short-term execution decisions to protect customer service and delivery performance</li><li>Lead plant-level weekly S&amp;OE cadences focused on exception management and recovery actions</li><li>Ensure adherence to global S&amp;OE standards, governance, and processes&nbsp;</li></ul> Operational Excellence &amp; KPI Delivery: <ul><li>Deliver against key metrics: On-Time -Delivery, Past Due, Lead Time Accuracy, Response Time, and Inventory Health</li><li>Drive root cause analysis and corrective actions for service gaps and supply constraints</li><li>Implement continuous improvement initiatives to enhance reliability, responsiveness, and efficiency</li><li>Standardize ways of working across factories to improve consistency and execution rigor</li></ul> Customer &amp; Commercial Alignment: <ul><li>Partner closely with Customer Care and Sales teams to ensure clear prioritization and fast response to demand changes</li><li>Support escalation management with structured, data-driven solutions</li><li>Translate commercial priorities into executable supply actions at plant level</li></ul> Managing Complexity, NPI &amp; Migrations: <ul><li>Ensure operational readiness for new product introductions and product migrations</li><li>Coordinate with planning, manufacturing, and supply teams to mitigate risks during transitions</li><li>Manage demand volatility and supply constraints with agility and structured decision-making</li></ul> Financial &amp; Service Performance: <ul><li>Balance service, cost-to-serve, and inventory objectives in daily execution decisions</li><li>Support achievement of working capital and cost targets through disciplined planning and execution</li><li>Use data and analytics to optimize trade-offs between service and cost</li></ul> People Leadership &amp; Capability Building: <ul><li>Lead and develop a team of ~10 S&amp;OE planners/analysts</li><li>Coach team on problem-solving, prioritization, and decision-making</li><li>Establish clear roles, accountability, and performance expectations</li><li>Build a high-performance, accountable, and collaborative team culture</li></ul> S&amp;OE Process Adoption &amp; Maturity: <ul><li>Drive adoption of global S&amp;OE processes, tools, and KPIs</li><li>Ensure high-quality data, system discipline, and process compliance (SAP, S4 Hana, IBP Response)</li><li>Support S&amp;OE maturity roadmap deployment at factory level</li></ul> Requirements: <ul><li>Bachelor’s degree in business administration, Supply Chain Management, Logistics, Industrial Engineering or a related field.&nbsp;</li><li>An MBA or master’s degree is preferred.</li><li>10+ years of experience in supply chain planning, or operations in a multinational environment.&nbsp;</li><li>Exposure to high-growth environments, NPI, and product migrations preferred.</li><li>Minimum of 4 years of experience in people management, leading diverse teams in a global environment.</li><li>Proven experience in Sales and Operations Execution (S&amp;OE) or related roles.&nbsp;</li><li>Experience in managing operational processes related to demand planning, supply chain management, and inventory optimization.</li><li>Excellent communication and interpersonal skills to engage effectively with cross-functional teams and stakeholders.</li><li>Strong analytical skills with the ability to interpret complex data and drive actionable insights.</li><li>Highly Competent with supply chain management software (SAP Must, IBP Response is a plus) and analytics tools.</li><li>Demonstrated leadership skills with the ability to lead and inspire diverse teams across different locations.</li><li>Understand business drivers and able to balance between short- and long-term objectives.</li></ul>

Responsibilities: Policies and Procedures: <ul><li>Localize and implement global quality policy, procedures and systems; and review QA reports within the entire factory in order to ensure the business procedures in line with QS and global standards.</li></ul> Quality System Maintenance: <ul><li>Monitor the implementation of the quality policies, including internal audit policy; monitor effectiveness of quality system,involve the quality-related best practices activities; and coordinate quality system audit from customers and third parties</li><li>in order to ensure meet business development requirement and align with global quality policies.</li></ul> Internal Quality Audit: <ul><li>Prepare internal audit plan in order to ensure meet business development requirement and align with global quality policy.</li></ul> External Audit: <ul><li>Prepare the related information according to customer or quality agencies audit needs; coordinate the entire audit process</li><li>provide action plans to external parties base on the report findings,in order to ensure meet business development requirement and align with global quality policy.</li></ul> Document Control: <ul><li>Maintain document control system in order to meet business development requirement and align with global quality policy.</li></ul> Customer Satisfactory Survey: <ul><li>Organize and review customer satisfactory survey in order to meet business development requirement and align with global quality policy.</li></ul> Quality Metrics: <ul><li>Summary and analyze plant quality metrics, support the function department to drive the performance improvement.</li></ul> Requirements: Education, Technical Qualification &amp; Experience <ul><li>College Graduate</li><li>5-8 years quality system working experience</li><li>Manufacture plant quality system experience</li><li>Project management experience</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>

Overview: <ul><li>The HR Technology and Integration (T&amp;I) organization was established as part of the HR team’s journey through digital transformation.&nbsp;</li><li>Working as part of our Global HR Technology &amp; Integration team this role to Build, implement and improves global HR systems, data, reporting and analytics platform.&nbsp;</li><li>As a product owner you will Develop and improve existing HR systems in partnership with our Global Talent Rewards &amp; HR Services teams to meet business requirements.</li></ul> Responsibilities: <ul><li>Act as a Global Product Owner to support our Global Total Rewards systems &amp; development.</li><li>Partner closely with our Global Total Rewards team to provide product knowledge &amp; solutions.</li><li>Proactively recommend solutions and ideas to help address technical problems that hinder productivity within Total Rewards.</li><li>Collaborates with Total rewards business teams to analyse requirements, develops and implements various solutions &amp; procedures.</li><li>Provides expertise in the analysis, design, development, and implementation of our Global HRIS system &amp; applications.</li><li>Streamline &amp; continuously improve system configuration to support Global Total Rewards team</li><li>Research solutions to support HR programs and processes.</li><li>Acts as a liaison with IT (Internal &amp; External) on technical issues and projects requiring data integration and other technical support.</li><li>Troubleshoots production issues, including problem research and analysis, and performing steps for resolution.</li><li>Documents system specifications, configurations, processes and procedures.</li><li>Partners with IT, HR and business to ensure effective use of methodologies and communication of test strategies, test results and performance through testing teams</li><li>Audits and reviews changes within HRIS to ensure proper controls and separation of duties and assists in establishing new controls, as needed.</li><li>Contributes to training program development and provides Tier 3 end-user support. Partners with COE’s &amp; Shared Services on enhancements, new rollouts, etc.</li><li>Works with external vendors and other service providers to ensure the efficient, accurate, and timely exchange of information</li></ul> Requirements: <ul><li>Bachelor degree (or equivalent); advanced degree preferred.</li><li>Typically requires minimum of 5+ years of SuccessFactors experience with end to end implementation projects</li><li>SuccessFactors certification with experience and expertise in modules like Compensation and Variable Pay</li><li>Hands on experience with SuccessFactors Employee Central (EC)</li><li>Candidate should ideally have been experience in at least 1 previous global / regional implementation • Provided recommendations with half-yearly and periodic system updates</li><li>Ability to communicate recommendations and solutions to non-technical clients and end users.</li><li>Experience building and executing test scripts for HR information system upgrades and enhancements. • Desired ITIL Service Management Certified</li><li>Advanced proficiency in MS Office, especially Excel</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: Customers Management: <ul><li>Handle incoming calls and emails from assigned accounts (customers) for various sales inquiries, including information on orders, lead times, incoterms, and stock availability.</li><li>Proactively communicate with customers to ensure understanding and resolution of all order-related issues.</li></ul> Analyse Demand Forecast/ Revenue &amp; Inventory Control: <ul><li>Analyze demand forecasts for assigned accounts (customers) and review/control inventory in accordance with business unit targets.</li><li>Conduct demand planning and upload forecasts to the system, managing replenishment orders and billing for consignment customer consumption.</li><li>Generate forecast and LE reports promptly and accurately for Monthly Sales Revenue.</li><li>Review customers actual demand and forecasts to meet their requirements and conduct comprehensive analysis to avoid excess inventory or non-moving stock.</li></ul> Customer Documentation &amp; File Management: <ul><li>File all relevant sales transactions, including purchase orders, order proof lists, order acknowledgments, shipping documents, shipment reports, customer&nbsp;</li></ul> Shipment Management: <ul><li>Prepare and process shipments according to customer requests.</li><li>Collaborate with Planning/Logistics to ensure on-time delivery based on customers request dates and confirm dates for STR performance.</li><li>Oversee drop-shipment orders and ensure continuous follow-up on shipment status, particularly for critical issues.</li><li>Submit credit releases to finance for held accounts.</li><li>Coordinate with Account Managers and customers to release shipments that are on hold.</li></ul> Payment Management: <ul><li>Follow up on open disputes/invoice discrepancies with Customer, Finance &amp; Sales to ensure the best possible A/R results. If necessary, issue credit/debit notes to resolve discrepancies.</li></ul> Requirements: <ul><li>Bachelor degree in related field.</li><li>5-10 years minimum in customer service/procurement or production planning, proficient in both written and spoken English, PC literate with Microsoft Window software.</li><li>Self-initiative, perseverance, people oriented and able to travel locally and aboard for short assignment</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>

Role Description:&nbsp; <ul><li>We are hiring a Supply Chain Project Engineer to lead and manage engineering and CAPEX projects within a manufacturing environment.&nbsp;</li><li>This role involves working closely with global engineering teams and plant operations to deliver projects on time, within budget, and aligned with business goals.</li></ul> Responsibilities: <ul><li>Lead end-to-end project execution (design, installation &amp; commissioning).</li><li>Support technical proposals, cost estimation, and project planning.</li><li>Coordinate with suppliers, contractors, and cross-functional teams.</li><li>Supervise installation and construction activities on-site.</li><li>Ensure projects meet EHS, quality, and food safety standards.</li><li>Manage budget, timelines, and resource planning.</li><li>Work closely with global engineering, production, maintenance, and operations teams.</li><li>Support CAPEX planning and execution for plant initiatives.</li></ul> Requirements: <ul><li>Bachelor’s degree in engineering as Mechanical, Electrical or equivalent. MBA or Management degree is preferred.</li><li>Working with manufacturing environment is preferred. Minimum 4 years of engineering experience with minimum 3 years for project management.</li><li>Knowledge of mechanical, electrical and construction/structure are required. Also, good computer background is a must.</li><li>English communication skill is necessary in both speaking and writing.</li><li>Able to work with government officers and public organizations.</li><li>Knowledge of food industry and financial issues including CAPEX&nbsp;</li></ul>

Role Description : <ul><li>This role supports project teams by controlling documentation for EPC projects—identifying, uploading and distributing engineering deliverables and maintaining electronic and hardcopy repositories with accurate indexing, revision control, metadata and access permissions.</li><li>It operates EDMS (SharePoint, ProjectWise), manages the change control lifecycle (issue/revise/approve/distribute/archive) and reviews documents for completeness and contractual/QMS compliance.</li><li>The role maintains traceability, transmittals and audit trails, prepares reports, supports technical reviews and handovers, follows up on pending reviews, and safeguards data integrity and confidentiality.</li><li>Control all documentation activities: identify, upload and distribute engineering deliverables.</li></ul> Responsibilities: <ul><li>Maintain electronic and hardcopy repositories with accurate indexing, revision control and retrieval.</li><li>Operate and administer EDMS (SharePoint, ProjectWise, etc.): uploads, metadata, permissions and folder structures.</li><li>Review drawings, specifications, change orders, submittals and vendor documents for completeness, format and contractual/QMS compliance; resolve discrepancies.</li><li>Manage the change control lifecycle: issue, revise, approve, distribute, archive and retire controlled copies.</li><li>Ensure documents are correctly dated, versioned and authorized prior to release.</li><li>Maintain traceability registers, revision histories, distribution lists, transmittals and audit trails.</li><li>Prepare transmittals, distribution notices, status updates and ad?hoc project reports.</li><li>Support technical reviews, coordination meetings and project closeout / handover documentation packs.</li><li>Proactively follow up on pending actions, approvals and overdue reviews.</li><li>Develop and maintain document procedures, metadata standards and templates; identify and implement improvements.</li><li>Provide day to day support for document access, retrieval, formatting/numbering and stakeholder queries, while maintaining access controls, data integrity and compliance with internal/ISO/contractual requirements.</li></ul> Requirements: <ul><li>Bachelor’s degree (any discipline) or equivalent.</li><li>2 to 6 years’ relevant document control experience, preferably in construction, engineering, manufacturing, oil &amp; gas or EPC project environments.</li><li>Experience supporting project QMS and contractual/client requirements is preferred.</li><li>Software Proficiency: Strong with MS Office (Word, Excel).</li><li>Experience with document management systems/EDMS such as Microsoft SharePoint, Bentley ProjectWise, DocuWare, or similar document control software. Familiarity with PDF tools and CAD/PDF handling.</li></ul>

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313 software development engineer Jobs found

Associate Director RA & QA

S & OE Manager

QMS – Sr Quality & Reliability Engg

EHS Manager

HR Systems and Workforce Analyst

Specification Sales Engineer, Low Voltage System Assemblies

Customer Service Specialist

Sr. Application Developer

Assistant Manager, SC Projects

Document Controller

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313 software development engineer Jobs found

Associate Director RA & QA

S & OE Manager

QMS – Sr Quality & Reliability Engg

EHS Manager

HR Systems and Workforce Analyst

Specification Sales Engineer, Low Voltage System Assemblies

Customer Service Specialist

Sr. Application Developer

Assistant Manager, SC Projects

Document Controller

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

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