Senior Manager, GCP & GVP, QA

Senior Manager, GCP & GVP, QA

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture – one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and innovate. Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific – it's deeply personal, grounded in the meaningful connections we have built.

Agios Pharmaceuticals is searching for a dynamic Sr. Manager, GCP & GVP Quality Assurance (QA) to join our growing GCP & GVP Quality team. We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Sr. Manager, GCP & GVP QA will be responsible for ensuring quality assurance and compliance of Agios Pharmacovigilance (PV) System and Agios sponsored interventional and non-interventional clinical trials in accordance with applicable Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) regulatory requirements (e.g., FDA, ex-US, country specific), ICH GCP/GVP Guidelines, Agios Standard Operating Procedures (SOPs), and current industry standards and practices. They support, maintain and ensure effectiveness of quality programs and documentation to assure compliance with GVP and GCP and inspection readiness.

What you will do:

• Responsible for collaborating cross-functionally to develop risk-based GCP/GVP internal and external audit program and annual audit plans.
• Conduct and/or oversee consultant auditors in the conduct of GCP/GVP audits of clinical trial internal and PV processes, GCP/GVP vendors, clinical investigator sites, clinical study documents and trial master files in accordance with annual audit plans.
• Provide timely GCP/GVP quality guidance and partner with key stakeholders to resolve compliance issues and support functions in the quality event management process, protocol deviations, risk management, issue escalation and CAPA development.
• Actively participate in the Clinical Trial Working Groups (CTWG) as the Quality Representative and serve as liaison to other GxP Quality teams as needed.
• Advise teams on controlled document development to ensure adherence to ICH and GCP/GVP guidelines and alignment with Agios Quality Policy and QMS.
• Support preparation, coordination and management of Health Authority inspections including Sponsor and Investigator Site Inspections.

What you bring:

• Bachelor's degree in a scientific discipline preferred or Associate's degree with commensurate experience; advanced degree preferred
• Minimum 4-6+ years of progressive experience working within a clinical, regulatory or quality environment in the pharmaceutical or biotechnology industry
• Must have applied experience in quality assurance auditing and applicable regulations
• Prior experience in regulatory inspections preferred
• Ability to establish collaborative working relationships with internal and external stakeholders
• Self-motivated and able to effectively prioritize and manage multiple projects
• Excellent time and project management skills Effective written and verbal communication skills with the ability to communicate clearly and concisely
• Ability to take ownership of specific projects, and to effectively lead and work with team members on projects as required
• Ability to travel (~25%) domestically and internationally

Concerned that you don't check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other's differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you're excited about this role but your previous experience doesn't align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!

Work Location:

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexibility. 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. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
• 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. The current base salary range for this position is expected to be between $131,035 and $196,553 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
• 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.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.