What are the responsibilities and job description for the Associate Director, GMP Quality Assurance position at Kinsley Power Systems?
Associate Director, GMP Quality Assurance
Find out if this opportunity is a good fit by reading all of the information that follows below.
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 rare 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 Associate Director to join our growing GMP Quality Assurance 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 Associate Director will be responsible for lot review / release activities for commercial drug substances and bulk drug products manufactured by Contract Manufacturing Organizations (CMOs). This Quality Assurance professional will assure the company, its affiliates and / or contractors associated with the manufacture, packaging, labeling, testing and distribution of products used for Phase III / process validation through commercial phases comply with cGMPs and standards as well as regulations of applicable authorities. The AD will have one direct report at Sr. Manager level also responsible for drug substance and bulk drug product and should provide guidance, learning and development opportunities, feedback, and opportunities for independence.
What you will do :
- Manage direct report, provide leadership, mentorship, and direction
- Execute commercial product release activities for drug substance and bulk drug product (batch and continuous manufacturing) including review and approval of Master Batch Records along with executed batch records. Provide back-up for commercial finished goods product release on as needed basis
- Provide Quality oversight and represent Agios QA on external CMO project teams. Manage relationships with CMOs. This may include periodic visits to CMOs, as required
- Coordinate QP release as appropriate
- Effectively interact with external contract manufacturers as well as work as part of an internal multidisciplinary team to support manufacturing, testing, and product complaint investigations
- Manage and address associated investigations, CAPAs, change controls, OOS, Material Review Boards, etc. for commercial products
- Implement necessary Quality Agreements
- Assist in preparing or reviewing CMC sections of regulatory submissions and collecting related CMO source documents
- Review and approve Annual Product Reviews (Vendor and Internal)
- Conduct or support audits of CMOs
- Provide QA support for regulatory inspections
- Provide QA expertise in the development of Agios quality systems, processes and procedures
What you bring :
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 :
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
J-18808-Ljbffr
