Principal Combination Product Quality Engineer
4 weeks ago
This role is considered a hybrid position, combining technical and leadership responsibilities.
Job Summary:The Principal Combination Product Quality Engineer will provide quality assurance support to Combination Product Design and Development, Design Transfer, and on-market support. This role will work collaboratively with Technical Operations and Quality teams to ensure safe and effective combination products are developed, brought to market, and maintained in accordance with global regulatory requirements and standards.
Key Responsibilities:- Lead quality oversight and provide QA strategy for Combination Product Design and Development programs, including design and development planning, defining design inputs and establishing design outputs, risk management, design verification and validation testing, and design transfer activities.
- Provide technical quality support for design-related continuous improvement efforts, design changes, and market expansions for in-clinic and on-market combination products.
- Provide technical quality oversight for root cause investigations, complaint trending, CAPAs, change controls, post-market safety reporting, and post-market surveillance activities.
- Provide quality oversight for device constituent and component suppliers used in combination products, including change management, quality agreements, and supplier audit expertise.
- Provide combination product quality support for regulatory intelligence processes, including assessments of any global evolving combination product regulations.
- Provide combination product QA expertise for Finished Good / Packaging activities, including the design and development of combination product assembly equipment and packaging operations and on-market support.
- QA support for combination product related internal audits, notified body audits, and regulatory inspections.
- Provide Quality support for regulatory submissions, meeting requests, and responses to questions.
- Lead/support efforts to enhance knowledge of combination product requirements throughout Quality organization.
- Escalate significant quality risks or issues to Quality leadership with proposed mitigation strategies.
- Bachelor's degree in engineering or sciences. Advanced degree preferred.
- 10 years of device and/or combination product cGMP experience.
- Experience of first-hand GMP management is preferred, and will include exposure to FDA or other authorities of similar standing.
- Understanding of global Device and Combination Product regulations, standards, and guidelines (e.g., 21 CFR Part 4, Part 803, Part 820, ISO 13485, ISO 14971, ISO 62366).
- Working knowledge of Pre-filled Syringe and Autoinjector technical standards (e.g., ISO 11040, ISO 11608, ISO 23908) is preferred.
- Experience maintaining design history, human factors, and risk management files throughout the product lifecycle for on-market products.
- Experience providing quality oversight of external partners (e.g., suppliers, CMOs, CTOs), including conducting external audits and authoring quality agreements.
- Ability to translate and implement evolving regulatory requirements into a corporate QMS including experience leading the creation and revision of SOPs in an electronic document control system.
- Excellent organizational, communication, and interpersonal skills including collaborating and working with a high-functioning team.
- American Society of Quality certifications for Biomedical Quality Auditor and/or Certified Quality Engineer are preferred.
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases.
Our culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential.
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