MANAGER, QUALITY ASSURANCE

This role is considered Hybrid.

Overview

The Manager of Quality Assurance Operations will work within the DP / CMC / Alliance QA Operations team and is responsible for providing oversight and support to all GMP aspects of drug product (DP) manufacturing, CMC and alliance management.

This role will work cooperatively with their counterparts in Quality Operations to provide quality oversight to ensure clinical through commercial lifecycle activities meet cGMP regulatory requirements and guidelines.

This position reports to the Director of Quality Assurance Operations.

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

Key Responsibilities

• Execute quality oversight of external manufacturing of both clinical and commercial drug product up through lot disposition to include review and approval of Deviations, Change Controls, CAPAs.
• Provide QA support of the CMC processes that may include authoring, review, approval of relevant regulatory documents sections (IMPD, IND, NDA, etc).
• Participate in CMC development processes in support of program establishment internally and at CMOs and in support of lifecycle advancement from clinical to commercial.
• Engage with alliance partners to assure compliance to their quality systems and practices as related to manufacturing through disposition of drug product.

Support establishment of best practices with alliance partners

• Provide quality oversight of our external manufacturing network quality management systems, ensuring compliance with regulations in all relevant markets.
• Collaborate and support internal colleagues and external vendors to navigate complex quality issues, ensuring compliant solutions are explored and meet patient needs.
• Oversee Investment Planning and oversight for related CapEx and OpEx.
• Collaborate with external partners to develop processes and systems that enable compliant and successful manufacturing, technology transfers, release, and lifecycle management of GMP clinical and commercial products, ensuring all program and corporate goals are met.
• Assuring appropriate GMP systems training of GMP personnel and customers.
• Ensure robust measurement and reporting tools are developed to enable accurate and timely reporting
• Collaborate with other groups in preparing the organization for Regulatory Inspections and support Regulatory Agency routine and Pre-Approval or other internal and expernal Inspections as needed
• Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective operation to support business needs.

Qualifications

• Minimum BS degree in life sciences, engineering or related field.
• A minimum of 8 years of experience in a pharmaceutical or biopharmaceutical company in roles of increasing responsibility in Quality Assurance.
• Ability to travel domestically and internationally and dedicate approximately 30% of time to travel.
• Experience working with external Contract Manufacturing Organizations in a virtual setting.
• Experience of first hand GMP management is essential, and will include exposure to FDA / EMA / PMDA / ANVISA or other authorities of similar standing.
• Experience working with investigational and commercial products in a Quality Operations role is preferred.
• Experience supporting parenteral drug manufacturing operations.
• Experience working with Alliance Partners is preferred.
• Experience leading, training and / or implementing root cause analysis and effective investigation practices.
• Experience driving out inefficiencies and improving turnaround times.

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 the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, 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.

Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.