Senior Manager/Associate Director, GVP/GCP QA

Senior Manager/ Associate Director, GCP/GVP Quality

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for genetically defined diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia. **

The impact you will make:**

Agios Pharmaceuticals is searching for a dynamic Sr. Manager/Associate Director, GCP/GVP Quality 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/Associate Director, GCP/GVP Quality 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. The individual will 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 in relation to compliance issues such as quality event management, protocol deviations, risk management and 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; advanced degree preferred
• Minimum 6-8 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 (~10-20%) domestically and internationally

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.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• 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.