Manager, GMP Quality Assurance, Clinical, QA

The Manager, GMP Quality Assurance - Clinical

The impact you will make: Agios Pharmaceuticals is searching for a dynamic Manager, GMP Quality Assurance - Clinical to join our growing QA team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities.

What you will do:

• Conduct product release activities for drug substance and drug product for all phases of development including review and approval of master batch records and executed batch records.
• Provide back-up support for clinical finished goods release on as-needed basis.
• Represent Agios QA on external CMOs project teams.
• Manage relationships with CMOs, which may include providing onsite oversight/monitoring of manufacturing campaigns as appropriate.
• Coordinate QP release as appropriate.
• Work collaboratively with key stakeholders on drug substance and drug product manufacturing strategies and plans to ensure investigational product releases within timelines.
• Effectively interact with external contract manufacturers and testing laboratories as well as work as part of an internal multidisciplinary team to support manufacturing, testing, and product complaint investigations.
• Assist in preparing or reviewing CMC sections of regulatory submissions.
• Manage and address associated Investigations, CAPAs, Change Controls, Material Review Boards, OOS, etc.
• Implement necessary Quality Agreements.
• Conduct audits of CMOs, Testing Laboratories

What you bring:

• Bachelor’s degree in biology, chemistry, life sciences or a related field.
• Minimum 6 years of Quality Assurance experience in a cGMP manufacturing environment.
• Experience related to oligonucleotide manufacture and/or process validation is a plus.
• Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations.
• Experience working in virtual manufacturing and vendor management is a plus.
• Exercises judgment within broadly defined practices and policies in determining solutions and actions.
• Demonstrates ability to identify and recognize critical decisions that will result in delays in schedule or operations that may jeopardize overall business activities.
• Knowledge of drug substance, drug product solid dosage and fill/finish manufacturing principles, equipment, and processes.
• Concerned that you don’t check off every box in the requirements listed above? Please apply anyway!

What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexible. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
• Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.