Senior Manager, GMP Quality
- Job Title
- Senior Manager, GMP Quality
- Job ID
- 27704360
- Work Remote
- Yes
- Location
- Boston, MA
- Other Location
- Description
-
Position: Senior Manager GMP Quality
Department: Quality Assurance
Reports to: Associate Director, GMP Quality
Location: Boston / Remote
Summary:
The senior manager of GMP Quality will be responsible for interfacing with global contract manufacturing organizations (CMOs) and providing GMP Quality oversight both internally and externally related to the quality management system, deviations, CAPAs, change control, technical transfer activities while ensuring activities are performed according to applicable guidelines and regulations.
Responsibilities:- Quality oversight of clinical trial material manufacturing, including but not limited to:
- Review and approve master batch records, master labeling records, product specifications, stability protocols, stability reports, and other process related documents from contract sites.
- Perform batch disposition through batch record and data review/approval and managing process deviations for timely release.
- Review and/or approve deviations, OOSs, CAPAs, change controls in an efficient manner for adequate and timely closeout of these events for both internal and external GMP and CMC activities.
- Review and approve manufacturing aseptic qualification protocols and reports
- Participate in CMO weekly/bi-weekly meetings, escalating issues as necessary
- Perform GMP / CMC vendor audits and internal audits, as assigned
- Assist in the review and development of quality metrics
- Assist in performance of internal audits, including audit plans and reports. Review and evaluate internal audit responses with current industry expectations to assure compliance.
- Support regulatory inspections internally or at contract sites involved in projects
- Contribute to the development of a strong quality culture
Competencies, Skills and Knowledge:- Minimum of 7+ years of Quality Assurance/Manufacturing Operations experience in pharmaceutical or biotech industry.
- In-depth knowledge of GMP and QA principles, practices, and standards; thorough understanding of FDA, EMA and ICH quality regulations.
- Ability to build relationships with internal stakeholders and external vendor/partners, and influence across disciplines and all levels.
- Highly motivated, flexible, with excellent organizational skills with keen attention to detail.
- Strong team player with a solution oriented, customer service approach.
- Experience in the operational Quality Management of (CMO) Contract Manufacturing Organizations producing products on behalf of another pharmaceutical company
- Experience with Regulatory / Health Authority Inspections preferred
- Demonstrated capability on building effective relationships with CMOs.
- Experience is biologics experience desired, but not required.
- Excellent verbal and written communication skills to effectively communicate with site staff and vendors.
- Ability to travel up to 15%
Requirements:- Bachelor’s degree in a scientific or engineering field.
AVEO Oncology (“AVEO”) is an oncology-focused biopharmaceutical company committed to providing innovative solutions to improve cancer patients lives. On January 20, 2023, AVEO was acquired by LG Chem, Ltd. (“LG Chem”), establishing a U.S. commercial presence for LG Chem and expanding LG Chem’s global oncology portfolio. AVEO continues to commercialize FOTIVDA® (tivozanib) in the U.S. To learn more about FOTIVDA efficacy, safety, and relevant resources, visit FOTIVDAHCP.com.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
- Quality oversight of clinical trial material manufacturing, including but not limited to:
