Manager, Finished Goods Quality Operations

This role is considered Hybrid.

Overview

The Manager of Finished Goods Quality Operations is responsible for providing support to all GMP aspects of US finished goods assembly, packaging and labeling. This role will work cooperatively with their counterparts throughout Quality Operations to provide quality oversight and support to ensure US lifecycle activities meet GMP regulatory requirements and guidelines. This position reports to the Associate Director - FG Quality Operations.

This position is a hybrid position and is located at the Kendall location in Massachusetts. The candidate selected for this role will be required to be on-site a minimum of two days per week.

Key Responsibilities

• Provide QA support (including qualification, auditing, contracting, and technical transfer activities) for assembly packaging and labelling activities performed by Alnylam sites or external contractors located in US.
• Oversee quality aspects of commercial finished goods specifications, artwork, label, and packaging operations at CMOs for global commercial supply and ensure compliance to internal standards and regulatory requirements.
• Execute Batch record review, certification, and release.
• Ensure serialization requirements are implemented within Alnylam and CMOs and assist in excursion response as necessary.
• Manage Quality Records (deviation, capa, change control, issue escalation) as it relates to product assembly, label, and packaging activities.
• Provide quality oversight and auditing for component suppliers for assembly, label, and packaging operations.
• Provide quality oversight and approval for project and technical documents, including specifications, qualification and validation documents, user requirements, engineering drawings, artwork, and label proofs.
• Provide quality oversight of our external US commercial finished goods manufacturing network quality management systems, ensuring compliance with regulations in all relevant markets.
• Collaborate with external partners to develop processes and systems that enable compliant and successful manufacturing, release, and lifecycle management of US 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 and maintained to enable accurate and timely reporting.
• Collaborate with other groups in preparing the organization for Regulatory Inspections.
• 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 5 years of experience in a pharmaceutical or biopharmaceutical company.
• Experience of first-hand GMP management including exposure to FDA or other authorities of similar standing.
• Experience leading, training, and/or implementing root cause analysis and effective investigation practices.
• Operations background to ensure value added and effective quality operations. Experience driving out inefficiencies and improving turnaround times.
• Experience in a Design Quality Engineering or Assurance role is a plus.

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.