Associate Director RA & QA

Registered Client Service Associate

Senior Manager of Parts

Production Technician I

Associate Data Engineer

Associate, Quality Assurance (QMS)

Customer Quality Engineer (CQE)

Java Backend Engineer

116365 Senior Manufacturing Engineer Kunshan

120368 Senior Manufacturing Engineer

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: <ul><li>Assist advisor(s) in servicing clients including preparing financial plans, conducting investment research and completing trades and transactions as described by the advisor.</li><li>Prepare and summarize client meetings by scheduling and confirming meetings, entering data into contact manager, building the agenda and summary of meetings, escorting clients to advisor meeting and providing vital follow-up.</li><li>Ensure new business paperwork is submitted efficiently which includes preparation of forms and documentation for submission to home office, acquisition of appropriate signatures, tracking of new insurance applications and coordination of rollovers.</li><li>Coordinate marketing events which include organizing the event, contacting vendors, finalizing event details, crafting marketing compliance documentation and managing event marketing reimbursement.</li><li>Provide general administrative duties such as answering the advisors’ phone, processing expense management reports, preparing routine client correspondence, supporting closes, setting up client documents and new business correspondence and alerts. </li></ul> Requirements: <ul><li>Bachelors degree or equivalent.</li><li>3 - 5 years relevant experience required.</li><li>Series 7 or ability to obtain within 150 days.</li><li>State securities agent registration (S63 or S66) or ability to obtain within 150 days.</li><li>Experience working in a client service environment.</li><li>Detail-oriented, strong math, and analytical skills. Good organization and time management skills.</li><li>Able to manage multiple priorities and prioritize effectively. Able to independently work with minimal direct supervision.</li><li>Able to communicate with all levels within the organization. Process oriented and can work with a team.</li><li>Strong computer and software skills. Preferred Qualifications:</li><li>State IAR registration (S65 or S66) or ability to obtain within 150 days.</li><li>Life, Accident, and Health licenses &amp; Variable Contracts or ability to obtain within 150 days.</li></ul>

Role Description:&nbsp; <ul><li>This person will be reporting to Aftersales Associate Director and will work daily with the Parts Distribution Manager.</li><li>The Senior Manager of Parts role is to develop and execute sales strategies, optimize pricing, build customer relationships, and drive revenue growth through spare parts sales on a national level.:</li></ul> Responsibilities: <ul><li>Develop and implement the national spare parts sales strategy, aligning it with the companys overall business goals and objectives.</li><li>Identify market opportunities, analyze customer needs, and devise strategies to maximize revenue generation from spare parts sales.</li><li>Collaborate with marketing teams and regional teams, to develop marketing campaigns and promotional activities to drive spare parts sales.</li><li>Provide leadership and oversight to the Parts Dealer Representatives team, ensuring strong dealer support, effective performance management, professional development, and resolution of escalated field and systemic parts-related issues in collaboration with supply chain and warehouse teams.</li><li>Work with finance to determine pricing strategies for spare parts based on market analysis, competitive landscape, and cost considerations.</li><li>Monitor price levels and margins to maximize profitability while remaining competitive in the market.</li><li>Analyze pricing trends and make adjustments as needed.</li><li>Build and maintain strong relationships with dealers. Identify customer needs, provide product information.</li><li>Conduct frequent dealer visits (up to 40% travel) US and Canada to address spare parts issues, promote parts sales, and drive optimal dealer stocking levels.</li><li>Collect and analyze sales data, market trends, and customer feedback to generate insights and reports.</li><li>Monitor sales performance against targets, identify areas for improvement, and develop action plans to enhance sales effectiveness.</li><li>Present reports and findings to senior management.</li></ul> Requirements: <ul><li>7–10 years of experience in sales, or aftersales in the agricultural machinery industry.</li><li>Proven experience working directly with dealers or in a dealership environment.</li><li>Proven track record of achieving sales targets and driving dealer network performance.</li><li>Strong mechanical aptitude with a comprehensive understanding of agricultural machinery, their applications, attachments, Implements.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment used for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.</li><li>Perform routine preventive maintenance on production equipment to ensure operational readiness and minimize downtime.</li><li>Support equipment and process qualifications, including execution assistance, documentation support, and adherence to qualification protocols.</li><li>Act as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as required.</li><li>Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.</li><li>Participate in line clearance, changeover, and cleaning activities to maintain continuous production operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity and cGMP requirements.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Contribute to continuous improvement initiatives focused on safety, efficiency, and product quality.</li><li>Work closely with cross-functional teams, including Engineering, Validation, and Quality, to support operational readiness.</li><li>Comply with all Environmental Health &amp; Safety (EHS) standards and maintain a clean and safe work environment.</li></ul> Key Stakeholders Internal <ul><li>Production Supervisor and Production Manager</li><li>Engineering and Maintenance</li><li>Validation and Quality Assurance</li><li>Materials and Warehouse Teams</li><li>Environmental Health &amp; Safety (EHS)</li></ul> External <ul><li>Equipment vendors and service technicians (as required)</li></ul> Requirements: Qualifications &amp; Experience <ul><li>High school diploma or equivalent required; Associate degree or technical certification in mechanical, engineering, or life sciences preferred.</li><li>Minimum 2 years of experience in pharmaceutical or other regulated manufacturing environments, including compounding, filling, inspection, or secondary packaging.</li><li>Prior experience with sterile products or IV bag manufacturing strongly preferred.</li><li>Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.</li><li>Experience operating automated production equipment using HMI or SCADA interfaces required.</li><li>Working knowledge of cGMP, aseptic processing, and controlled substance regulations preferred.</li><li>Ability to read, understand, and follow SOPs, maintenance procedures, and qualification protocols.</li></ul> Skills &amp; Competencies <ul><li>Strong technical and mechanical problem-solving skills</li><li>High attention to detail with a commitment to quality and data integrity</li><li>Ability to work effectively in a fast-paced, highly regulated environment</li><li>Strong verbal and written communication skills</li><li>Team-oriented mindset with a collaborative approach</li><li>Comfortable working in cleanroom environments with PPE requirements</li></ul>

Responsibilities: <ul><li>Ability to troubleshoot problems in a live environment and provide real time help with critical issues.</li><li>Write code that is easily understood and maintainable by other team members.</li><li>Keep up to date with developments in technologies we are using.</li><li>Ability to communicate and work effectively, supporting various business departments.</li><li>Ability to work in fast-paced interdisciplinary environment.</li></ul> Requirements <ul><li>BA/BS in Computer Science or equivalent practical experience.&nbsp;</li><li>At least 3+ years of post-university experience as a full-stack engineer.</li><li>Solid knowledge of programming fundamentals—algorithms, data structures, design patterns, and paradigms.</li><li>Strong knowledge of Python.</li><li>Solid knowledge SQL and relational databases.</li><li>Knowledge of Extract-Transform-Load (ETL) and big data analytics tools.</li><li>Experience working in a cloud environment (AWS, Azure, GCP).</li><li>Familiarity with popular Python data analytics frameworks.</li><li>Familiarity with Snowflake or other large analytics engines.</li><li>Experience with data warehousing and working in environments with large scale, complex analytics requirements.</li><li>Familiarity with DAG-based job scheduling tools.</li><li>Cloud-native container orchestration platforms and tools.</li><li>Experience working in the Financial Services industry.</li></ul>

Role Description: <ul><li>The Entry-Level Associate, Quality Assurance supports the Quality Management System (QMS) and documentation processes at the Chestnut Ridge site.</li><li>This role is designed for individuals beginning their career in pharmaceutical quality assurance and provides hands-on experience in maintaining compliance and supporting documentation workflows in a regulated environment.</li></ul> Responsibilities: <ul><li>Assist in organizing and maintaining QMS documentation including SOPs, CAPAs, deviations, and complaints.</li><li>Support the preparation and tracking of quality metrics and trending reports.</li><li>Help coordinate internal audits and document audit responses.</li><li>Participate in documenting product quality complaints and adverse event records.</li><li>Aid in digitizing logbooks and checklists using electronic systems.</li><li>Collaborate with cross-functional teams to ensure timely and accurate documentation updates.</li><li>Provide administrative support for change control processes and quality-related meetings.</li><li>Assist in preparing documentation for regulatory inspections and external audits.</li><li>Maintain document control systems and ensure timely review and archival of QA records.</li><li>Support training documentation and tracking for QA-related procedures.</li><li>Help with data entry and analysis for quality reports using basic statistical tools.</li><li>Monitor document lifecycle and ensure version control compliance.</li><li>Participate in continuous improvement initiatives related to documentation and QMS processes.</li></ul> Requirements: Education &amp; Experience <ul><li>Required Education: Bachelor’s degree in Pharmaceutical Sciences or a related field.</li><li>Preferred Education: Master’s degree is a plus.</li><li>Experience: 1–3 years in a pharmaceutical or regulated industry (internships or co-op experience acceptable).</li><li>Tools/Technologies: Familiarity with QMS platforms and electronic documentation systems preferred.</li></ul> Physical Requirements <ul><li>On-site role at Chestnut Ridge, NY.</li><li>Standard work hours: 8 AM to 5 PM.</li><li>No travel required.</li><li>No lifting or driving responsibilities.</li></ul>

Responsibilities:﻿ <ul><li>Serve as the main contact for customer complaints and quality issues—coordinate root cause analysis and corrective actions (8D, CAPA), ensuring robust and timely responses.</li><li>Monitor complaint trends, DPPM, COPQ, warranty returns, and initiate improvement initiatives when necessary</li><li>Investigate internal and supplier quality issues; lead supplier audits, performance evaluations, process audits, and enforce corrective measures</li><li>Review customer contracts and quality requirements (PPM targets, FAI demands, Q-certifications); communicate deviations and ensure alignment across internal teams.&nbsp;</li><li>Conduct onsite visits to customer plants and supplier locations for quality discussions, complaint containment, and relationship building</li></ul> Requirements: <ul><li>Must have experience in the automotive industry (Tier 1 or Tier 2).</li><li>Familiarity with quality management for connectors, harnesses, and cable products is preferred (but not mandatory).</li><li>Approximately 5 years, ideally under 30 years of age, with growth potential.</li><li>Familiarity with customer quality complaint handling processes.</li><li>Proficiency in quality tools (e.g., 8D, 5 Whys, FMEA).</li><li>Preference will be given to candidates with AQE/PQE experience.</li><li>Working proficiency in English is a plus.</li><li>Associate degree or higher; a bachelors degree is preferred.</li></ul>

Responsibilities: <ul><li>Collaborate with team, high availability, concurrent and fault tolerant software systems.</li><li>Significantly contribute to development of Aladdin’s global, multi-asset trading platform.</li><li>Work with product management and business users to define the roadmap for the product.</li><li>Design and develop innovative solutions to complex problems, identifying issues and roadblocks.</li><li>Apply validated quality software engineering practices through all phases of development.</li><li>Ensure resilience and stability through quality code reviews, unit, regression and user acceptance testing, dev ops and level two production support.</li><li>Be a leader with vision and a partner in brainstorming solutions for team productivity, efficiency, guiding and motivating others.</li><li>Drive a strong culture by bringing principles of inclusion and diversity to the team and setting the tone through specific recruiting, management actions and employee engagement.</li><li>For VP Level: In addition to above, a VP level candidate should be able to lead individual projects priorities, deadlines and deliverables using AGILE methodologies.</li></ul> Requirements: Qualifications: <ul><li>B.S. / M.S. degree in Computer Science, Engineering, or a related subject area</li><li>For VP Level: 8+ years of proven experience</li><li>For Associate Level: 4+ years of experience</li></ul> Skills and Experience: <ul><li>A proven foundation in core Java and related technologies, with OO skills and design patterns</li><li>Track record building high quality software with design-focused and test-driven approaches</li><li>Good hands-on object-oriented programming knowledge in Java, Spring, TypeScript, JavaScript, Microservices, Angular (2.0+), React.</li><li>Strong knowledge of Open-Source technology stack (Spring, Hibernate, Maven, JUnit, etc.).</li><li>Experience with relational database and/or NoSQL Database (e.g., Apache Cassandra)</li><li>Great analytical, problem-solving and communication skills</li><li>Some experience or a real interest in finance, investment processes, and/or an ability to translate business problems into technical solutions.</li><li>For VP Level: In addition to the above, a VP level candidate should have experience leading development teams, projects or being responsible for the design and technical quality of a significant application, system, or component. Ability to form positive relationships with partnering teams, sponsors, and user groups.</li></ul> Nice to have and opportunities to learn: <ul><li>Exposure to building microservices and APIs ideally with REST, Kafka or gRPC.</li><li>Experience working in an agile development team or on open-source development projects.</li><li>Experience with optimization, algorithms or related quantitative processes.</li><li>Exposure to high scale distributed technology like Kafka, Mongo, Ignite, Redis</li><li>Experience with Cloud platforms like Microsoft Azure, AWS, Google Cloud</li><li>Experience with DevOps and tools like Azure DevOps</li><li>Experience with AI-related projects/products or experience working in an AI research environment.</li><li>A degree, certifications or opensource track record that shows you have a mastery of software engineering principles.</li></ul>

Responsibilities:&nbsp; <ul><li>Design of non-standard equipment: pin insertion machines, bending machines, assembly machines, testing machines, and glue dispensing machines.&nbsp;</li><li>Involves designing equipment for the entire production line, including automation levels, robotic arms, and fixture efficiency improvements, aimed at enhancing the overall equipment effectiveness (OEE) of the production process.&nbsp;</li><li>Designing and improving equipment layouts, manufacturing processes, and production controls</li><li>Identifying and resolving operational problems, such as bottlenecks or material use variances&nbsp;</li><li>Ensuring compliance with workplace safety, health, and regulatory requirements</li><li>Responsible for production equipment manufacturing and subsequent process improvements.</li></ul> Requirements:&nbsp; <ul><li>At least an associate degree, age under 43.&nbsp;</li><li>Strong industry background, especially in automotive electronics.&nbsp;</li><li>Experience in non-standard equipment design preferred; candidates with SMT and surface mount technology experience will not be considered.&nbsp;</li></ul>

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13 associate Jobs found

Associate Director RA & QA

Registered Client Service Associate

Senior Manager of Parts

Production Technician I

Associate Data Engineer

Associate, Quality Assurance (QMS)

Customer Quality Engineer (CQE)

Java Backend Engineer

116365 Senior Manufacturing Engineer Kunshan

120368 Senior Manufacturing Engineer

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13 associate Jobs found

Associate Director RA & QA

Registered Client Service Associate

Senior Manager of Parts

Production Technician I

Associate Data Engineer

Associate, Quality Assurance (QMS)

Customer Quality Engineer (CQE)

Java Backend Engineer

116365 Senior Manufacturing Engineer Kunshan

120368 Senior Manufacturing Engineer

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

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

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