Principal Combination Product Quality Assurance Specialist
4 weeks ago
The Principal Combination Product Quality Assurance Specialist will provide QA support to Combination Product Design and Development, Design Transfer, and on-market support.
This role will work cooperatively with their counterparts throughout Technical Operations and Quality to ensure safe and effective combination products are developed, brought to market, and are maintained in accordance with global regulatory requirements and standards.
This position reports to the Associate Director - FG Quality Operations.
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 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.
- Evaluate and mitigate significant quality risks or issues.
Requirements:
- Bachelor's degree in engineering or sciences.
- 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.
- American Society of Quality certifications for Biomedical Quality Auditor and/or Certified Quality Engineer are preferred.
About Alnylam:
Alnylam Pharmaceuticals is a leader in the development of innovative medicines based on RNA interference (RNAi) technology. With a strong commitment to scientific excellence and a passion for transforming lives, Alnylam is dedicated to building a diverse and inclusive workplace where employees can thrive and reach their full potential.
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