Site Quality Leader

HR PARTNER II

EHS Analyst

Associate Director RA & QA

Senior Software Engineer 1 (.Net)

Product Specialist – Pharma Sales

Senior Data Scientist 2

Senior Software Engineer 2 (Ruby on Rails)

Staff Software Engineer

Senior Software Engineer 2

Role Description: <ul><li>The Site Quality Leader is responsible for the administration, supervision, and development of the Wilsonville Quality Assurance and Quality Engineering functions.&nbsp;</li><li>This position is responsible for ensuring full compliance to the regulatory requirements of 21 CFR 820, ISO13485, MDR and other applicable regulations including production and process controls.&nbsp;</li><li>The Site Quality Leader will report to the Global Head of Quality Operations.</li></ul> Responsibilities: <ul><li>Ensure that Material Review Boards are in place to ensure products are appropriately dispositioned within a timely manner, while ensuring appropriate corrective and preventive actions are initiated and regulatory requirements are met.</li></ul>&nbsp;Develop and implement systems to assure that development as well as production teams receive support in the following areas: <ul><li>Quality planning, including inspection techniques and sampling methods</li><li>Statistical Analysis</li><li>Application of required regulatory standards</li></ul> Develop and implement procedures and systems to assure product manufactured for human use meets design and functional specifications. These systems are to include as a minimum: <ul><li>Delivery of raw materials and components</li><li>Manufactured devices and equipment</li><li>Documentation associated with these functions</li><li>Develop, track, and report on the following administrative systems:</li><li>Department metrics</li><li>Department objectives</li><li>Personnel development and training</li><li>Support regulatory agency and customer quality audits.</li><li>Ensure the conformity of the components and products are appropriately checked in accordance with the Quality Management System before release.</li><li>Responsible for assisting and training associates in concepts of probability and statistics.</li><li>Responsible for failure appraisal and analysis (internal and external).</li><li>Authority to place products or processes on hold.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Corrective and Preventive Action program</li><li>Based on operational/quality requirements, assist in test equipment selection and validation.</li><li>Utilize formal problem solving techniques to resolve product and/or process related issues.</li><li>As required, lead cross-functional teams to support resolution of product and/or process related issues or objectives.</li><li>Work with suppliers of both raw materials and components, to improve product quality and/or resolve quality issues.</li><li>Be innovative, knowledgeable and intensely committed to ensure that every product and service we supply conforms to FDA and Quality System Regulations..</li></ul> Requirements: <ul><li>Bachelors Degree with a scientific or engineering emphasis.</li><li>ASQ Certified Quality Engineer recommended. Six Sigma Green/Black belt recommended.</li><li>7-10 years experience in a related regulatory environment.</li><li>Experience should include positions at senior levels within the medical device organizations.</li></ul>

Responsibilities: <ul><li>Understand business cycles and talent needs to develop and strengthen workforce capabilities aligned with business objectives.</li><li>Support recruiting and staffing initiatives and guide managers on compensation decisions.</li><li>Manage Family and Medical Leave Act (FMLA) and leave benefits through external program providers.</li><li>Facilitate and develop HR-related training and resources for managers to strengthen leadership and people management capabilities.</li><li>Support compensation and benefits administration, payroll, and salary management activities.</li><li>Align HR priorities with business unit strategies while balancing broader HR functional goals.</li><li>Maintain a positive and productive employee relations environment.</li><li>Drive a culture of continuous improvement and operational excellence.</li><li>Act as a change agent to support transformation initiatives, learning, and development programs.</li><li>Support employee engagement, culture initiatives, and inclusion &amp; diversity programs.</li><li>Partner with value stream managers and supervisors to develop employee training programs.</li><li>Ensure effective onboarding, orientation, and employee assimilation processes.</li></ul> Requirements: <ul><li>Bachelor’s degree in Human Resources or related field.</li><li>3–5+ years of experience as an HR Generalist within a manufacturing environment.</li><li>Prior plant/manufacturing site HR experience preferred with expertise in Employee Relations, Talent Acquisition, Coaching, and Development.</li><li>Experience working within cross-functional teams and influencing stakeholders.</li><li>Ability to manage ambiguity, risk, and shifting priorities.</li><li>Strong understanding of employment laws and HR best practices.</li><li>Proven experience in HR Operations, Compensation &amp; Benefits, Talent Management, Employee Relations, and Labor Relations.</li><li>Continuous improvement mindset with strong operational execution.</li><li>Strong strategic thinking and hands-on execution capabilities.</li><li>Excellent communication, facilitation, and presentation skills.</li><li>Ability to build trust and credibility across all organizational levels.</li><li>Strong interpersonal, organizational, analytical, and process-oriented skills with a strong sense of urgency.</li></ul>

Responsibilities: Planning; <ul><li>Initiate annual EHS training plan &amp; EHS internal audit plan in order to meet the department annual operating plan.</li></ul> Procedures &amp; Document Update; <ul><li>Review &amp; update EHS procedure according to internal &amp; external audit finding.</li><li>Initiate, update and execute EHS policies or procedures according to national laws and regulations or S.A.F.E or Global policies in order to fulfill company EHS system and make work efficient.</li></ul> Safety and Health Management: <ul><li>Submit application to Safety Bureau for Safety and Health Impact Assessment and other required permits or registration in order to meet the requirement of national laws and regulations.</li><li>Conduct Safety Standard Management review and follow in velocity EHS system.</li><li>Coordinate industrial hygiene monitoring, evaluation, medical surveillance in order to prevent occupational disease.</li><li>Maintain SAFE and environment tool with continuous improvement.</li><li>Follow up Incident investigation, correction and Injury Trend Analysis in order to prevent incidents.</li><li>Conduct canteen and dormitory inspection with Admin. to supervise food safety and fire safety,in order to prevent incidents.</li><li>Conduct contractor &amp; supplier EHS management, issuing non-routine high risk task permits, in order to prevent incidents.</li></ul> EHS Projects: <ul><li>Lead and follow up JSA, LOTO, Ergo, Machine Guarding,BBS, Nearhit reporting, PPE management, IH, Environmental and etc.</li><li>Coordinate the Kaizens and other EHS activities, in order to meet SAFE and 5 star requirement and prevent incidents.</li></ul> Audit; <ul><li>Implement routine EHS internal audit and examine;</li><li>Prepare necessary material or data sheet for S.A.F.E ,customer, local government, global audit;in order to ensure meet compliance requirements.</li></ul> Reporting &amp; Training: <ul><li>Prepare Monthly EHS performance report in order to present EHS performance;</li><li>Organize health and safety related training to employee in order to promote the awareness of health and safety."</li></ul> Requirements: <ul><li>Minimum 5+ years of EH&amp;S experience required;</li><li>Possesses a strong grasp of Malaysias EHS laws and regulations, EHS Greenbook,can conduct compliance assessments.</li><li>Autonomous ability in conducting audits and inspections of all aspects of EHS;</li><li>Good reading and writing in English &amp; Chinese</li><li>Skilled in leveraging Excel for data analysis, visualization, and tracking key metrics.</li></ul>

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>Design, develop, and maintain robust, scalable, and secure web applications.</li><li>Utilize Object-Oriented design principles and best practices to ensure high-quality software.</li><li>Write clean, efficient, and well-documented code in C# with both .NET Core and .NET Framework.</li><li>Ensure adherence to Web Standards (XML, JSON, HTML, CSS, APIs, Web Services).</li><li>Create and manage CI/CD pipelines using tools like Jenkins, GitLab CI, or Azure DevOps.</li><li>Automate repetitive tasks in the software development lifecycle, including builds, testing, and deployments.</li><li>Configure and maintain infrastructure for CI/CD pipelines, including servers and containerized environments.</li><li>Leverage cloud platforms like AWS, Azure, or GCP for scalable infrastructure and application management.</li><li>Incorporate DevOps principles to foster collaboration between development and operations teams.</li><li>Integrate unit testing frameworks (e.g., NUnit) into pipelines to ensure robust software quality.</li><li>Utilize test-driven development practices to enhance software reliability.</li><li>Work closely with developers, QA engineers, and operations teams to streamline workflows and address feedback.</li><li>Demonstrate strong communication skills to present ideas, solutions, and progress effectively.</li><li>Monitor CI/CD pipeline execution and troubleshoot issues promptly to minimize downtime.</li></ul> Requirements: <ul><li>Demonstrated knowledge of software application development (certifications and experience considered in lieu of a degree).</li><li>6+ years of experience in software development using C# and .NET.</li><li>5+ years of experience in developing .NET applications, including .NET Core and .NET Framework.</li><li>Proven experience in building enterprise-level web applications.</li><li>Strong background in Object-Oriented design and development.</li><li>Advanced JavaScript experience, including closures and prototype inheritance.</li><li>Proficiency in SQL (DDL and DML) and experience managing database structures.</li><li>Solid understanding of Web Standards (XML, JSON, HTML, CSS, APIs, Web Services).</li><li>Demonstrated use and knowledge of design patterns and cloud-native technologies.</li><li>Experience with Agile methodologies and iterative development processes.</li><li>Proficiency in CI/CD tools such as Jenkins, GitLab CI, Azure DevOps, or AWS Code Pipeline is required.</li></ul> Preferred work experience and skills: <ul><li>Strong proficiency in C#, JavaScript, and scripting languages like Bash, Python, or PowerShell for task automation.</li><li>Expertise in popular CI/CD platforms like Jenkins, GitLab CI, Azure DevOps, or AWS Code Pipeline.</li><li>Deep understanding of Git and branching strategies for effective code management.</li><li>Familiarity with unit testing frameworks like Unit, JUnit to integrate automated testing into pipelines.</li><li>Knowledge of cloud platforms like AWS, Azure, or GCP for scalable infrastructure management.</li><li>Familiarity with containerized environments (e.g., Docker, Kubernetes) and microservices architecture.</li><li>Exceptional problem-solving and analytical skills.</li><li>Strong communication and collaboration abilities.</li><li>Self-motivated and able to work independently with minimal supervision.</li><li>Detail-oriented with excellent organizational skills.</li></ul>

Responsibilities:&nbsp; <ul><li>Execute sales and marketing activities to achieve sales targets assigned.&nbsp;</li><li>Track sales progress against key performance indicators and sales plans. Prioritize and review daily sales activities with the Sales Manager/Business Unit Head to enable an efficient and effective work execution.&nbsp;</li><li>Deliver product presentations to the healthcare professionals to ensure thorough understanding of the products.&nbsp;</li><li>Identify and develop new business opportunities with new and existing healthcare professionals to expand customer base and market share.&nbsp;</li><li>Support internal stakeholders in relationship development with key customers. Conduct market and competitor research on project basis.&nbsp;&nbsp;</li><li>Ensure compliance with the company policies and the local industry’s code of conduct to ensure that the company conducts business with integrity.&nbsp;</li></ul> Requirements:&nbsp; <ul><li>Degree or professional qualification in a Science- or Medical-related discipline.&nbsp;</li><li>Minimum of 1 year working experience in dealing with healthcare professionals at pharmaceutical or medical device industry.&nbsp;</li><li>Willing to travel outstation and cover more than one area.&nbsp;</li><li>Possess business awareness and analytical skills, strong communication and negotiation skill and able to work and travel independently.&nbsp;&nbsp;</li><li>Proficient in English, both written and spoken.&nbsp;</li><li>A valid driving license with an own car.</li></ul>

Responsibilities: <ul><li>Lead the design and development of LLM-powered solutions for clinical summarization, intelligent chat, and document understanding to improve patient care outcomes.</li><li>Architect and implement end-to-end machine learning pipelines, including Retrieval-Augmented Generation (RAG) systems using vector databases such as Pinecone and Weaviate.</li><li>Fine-tune and optimize state-of-the-art language models (e.g., GPT, LLaMA, Mistral) and apply advanced prompt engineering to address specialty-specific healthcare use cases.</li><li>Own project delivery end to end, collaborating with stakeholders to ensure AI solutions are ethical, scalable, reliable, and well-governed.</li><li>Mentor and support junior data scientists, fostering a culture of experimentation, learning, and innovation.</li></ul> Requirements: <ul><li>Experience: 8–12 years in Data Science/ML, with at least 3+ years specifically focused on LLMs and Generative AI.&nbsp;</li><li>Technical Mastery: Deep hands-on expertise in Python and frameworks like PyTorch, Hugging Face, LangChain, or LlamaIndex.&nbsp;</li><li>Cloud Fluency: Proven ability to deploy models at scale using AWS SageMaker, Azure ML, or GCP Vertex AI.&nbsp;</li><li>MLOps Mindset: Experience with MLflow, Airflow, Docker, and Kubernetes to ensure our "bold innovations" are also stable and reliable.&nbsp;</li><li>Academic Foundation: A strong grasp of statistical analysis and evaluation techniques to mitigate hallucinations and ensure clinical accuracy.&nbsp;</li></ul>

Responsibilities: <ul><li>Design, build, and maintain scalable backend systems using Ruby on Rails, ensuring reliability, performance, and an exceptional user experience.</li><li>Collaborate closely with Product and Design teams to translate customer needs into high-impact technical solutions, balancing simplicity with scalability.</li><li>Define and communicate clear technical specifications by breaking down complex requirements into actionable, well-structured implementation plans.</li><li>Uphold engineering excellence through test-driven development (TDD), comprehensive integration testing, and disciplined API design and management.</li><li>Optimize data storage and messaging systems, including PostgreSQL, NoSQL databases, and RabbitMQ, to ensure system efficiency and stability.</li><li>Mentor and support fellow engineers through pairing, knowledge sharing, and leading refactoring initiatives to continuously raise team-wide technical standards.</li></ul> Requirements: <ul><li>Technical Depth: A degree in Computer Science (or equivalent experience) and 3+ years of professional mastery in Ruby and its frameworks (Rails, Grape, or Sinatra).&nbsp;</li><li>A Quality Mindset: A strong TDD advocate who lives and breathes RSpec.&nbsp;</li><li>Systems Thinking: Deep experience with relational databases and message-driven architectures. You understand how parts of a system talk to one another.&nbsp;</li><li>Growth Mindset: A drive to learn and take ownership. You dont wait for permission to make things better.&nbsp;</li><li>Effective Communication: The ability to influence technical decisions and explain "the why" to both technical and non-technical stakeholders.</li></ul>

Responsibilities:&nbsp; <ul><li>Lead the architecture and design efforts, aligning with future scalability and business objectives.</li><li>Provide mentorship, set technical direction, and drive excellence in the team.</li><li>Establish technical roadmap with cross-functional teams and stakeholders, ensuring alignment with business objectives.</li><li>Simplify and break down complex requirements into manageable deliverables and milestones through development of technical specifications.</li><li>Ensure deliverables meet the functional and non-functional criteria, and drive changes proactively where outcomes are misaligned.</li><li>Promote a culture of continuous improvement by guiding other engineers through design, code, and operational reviews.</li></ul> Requirements: <ul><li>Deep Expertise: 10+ years of software development experience, with at least 3 years in a formal technical leadership role.&nbsp;</li><li>The Java Stack: You are an expert in Java, Spring Boot, and SQL, with a proven track record of building distributed services that dont fail.&nbsp;</li><li>Cloud Native: Extensive experience with public cloud services (we prefer AWS) and a deep understanding of fault-tolerant, distributed systems.&nbsp;</li><li>Strategic Vision: You can zoom out to see the business objective and zoom in to solve a granular technical bottleneck.&nbsp;</li><li>Collaborative Leadership: Exceptional communication skills. You can explain architectural trade-offs to stakeholders and inspire engineers in the same hour.&nbsp;</li><li>Education: Bachelor’s or Master’s degree in Computer Science or a related technical field.&nbsp;</li></ul>

Responsibilities:&nbsp; <ul><li>Lead and own the architectural design of the cloud platform, ensuring solutions align with scalability requirements and long-term business objectives.</li><li>Define and execute the technical roadmap in collaboration with cross-functional stakeholders to advance the product vision.</li><li>Translate complex business requirements into clear technical specifications, actionable milestones, and high-quality deliverables.</li><li>Drive engineering excellence by proactively managing functional and non-functional requirements, and initiating corrective action when outcomes diverge from expectations.</li><li>Mentor and develop engineers through structured design, code, and operational reviews, fostering a culture of continuous improvement and technical rigor.</li></ul> Requirements: <ul><li>Experience: 10+ years of software development experience, with at least 3+ years in a technical leadership role.&nbsp;</li><li>Education: Bachelor’s or Master’s degree in Computer Science or a related field.&nbsp;</li><li>Deep Technical Expertise: Extensive mastery of Java, Spring Boot, and SQL.&nbsp;</li><li>Cloud &amp; Distributed Systems: Proven experience designing and operating modern cloud-native, fault-tolerant distributed services (preferably on AWS).&nbsp;</li><li>Architecture: Solid understanding of Microservices and REST API standards.&nbsp;</li><li>Quality Focus: Strong experience in writing Unit and API tests to ensure platform stability.&nbsp;</li><li>Soft Skills: Exceptional strategic thinking and the ability to communicate technical concepts to non-technical stakeholders.</li></ul>

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24 medical affairs Jobs found

Site Quality Leader

HR PARTNER II

EHS Analyst

Associate Director RA & QA

Senior Software Engineer 1 (.Net)

Product Specialist – Pharma Sales

Senior Data Scientist 2

Senior Software Engineer 2 (Ruby on Rails)

Staff Software Engineer

Senior Software Engineer 2

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24 medical affairs Jobs found

Site Quality Leader

HR PARTNER II

EHS Analyst

Associate Director RA & QA

Senior Software Engineer 1 (.Net)

Product Specialist – Pharma Sales

Senior Data Scientist 2

Senior Software Engineer 2 (Ruby on Rails)

Staff Software Engineer

Senior Software Engineer 2

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.