Engineer III - Combination Product Quality Assurance (CPQA)

Overview

The Engineer III - Combination Product Quality Assurance (CPQA) is responsible for providing quality oversight for the development and life cycle management for combination products at Alnylam. This role will work cooperatively with their counterparts throughout the combination product development team and QA providing quality oversight and support to ensure clinical through commercial lifecycle activities meet cGMP regulatory requirements and guidelines including Part 4 for combination products. This position reports to the Senior Manager of CPQA.

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

Key Responsibilities

• Review of post-market surveillance activities for an on-market program including device constituent and component QA support for change controls, complaints, and post-market surveillance meetings
• Provide new product and sustaining QA support for design and development activities of combination product design history, human factors, and risk management files.
• Provide quality support for notified body opinion submissions for significant changes
• Provide combination product QA support for Quality Management System (QMS) improvement efforts
• Collaborate with various CMOs and represent Alnylam QA. Help ensure that CMOs adhere to various requirements and oversee any required manufacturing changes.
• Identify and drive process/procedure improvements to increase efficiency. Lead and manage various QA feeder systems to ensure continued compliance.

Qualifications

• Bachelor’s degree in engineering or sciences. Advanced degree preferred
• Minimum of 3 years of relevant experience, 5 years preferred, in a regulated industry preferably with medical device, combination product, or QA experience.
• 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)
• Ability to translate and implement evolving regulatory requirements into internal SOPs
• Proficient technical writing skills
• Excellent organizational, communication, and interpersonal skills including collaborating and working with a high functioning team

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.