Sr Manager, Combination Product Quality Engineering

This role is considered Hybrid.

Overview

The Principal Combination Product Quality Engineer is responsible for providing 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.

This position is a hybrid role and is located at the Kendall location in Massachusetts.

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 (e.g., design focused) 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.

Qualifications

• 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

About Alnylam: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. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. 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. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients.