Senior Manager, Small Molecule QA
- Waltham, MA
Responsible for the Quality oversight of assigned projects in production of the regulatory starting material(s), API and drug product, and the various activities in the disposition of commercial product. Review and approve non-conformance and CAPA issues, as well as approve and monitor the validated status of the GMP environment. Responsibilities include conducting quality audits of contracted production services and managing the vendor qualification and periodic audit program. The Sr. Manager will also perform training on the company quality systems, as needed and will write and review company SOPs, and may participate in the auditing of regulatory dossiers.
- Review and approve master batch records, master labeling/packaging 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 control in an efficient manner for adequate and timely closeout of these events
- Maintain the vendor qualification program through timely audits and follow-up actions
- Write, revise and periodically review SOPs to further develop the Quality System and control over the quality of vendor services and products
- Review and approve manufacturing validation protocols and reports..
- Assist in the development and tracking of Quality metrics. Prepare metrics for the Management Review and Annual Product Review.
- Assist in the QC review of various documents, including regulatory dossiers and reports
- As appropriate, attend project meetings and provide development quality input and lead the resolution of quality-related issues
- Clearly communicate issues to vendors and GSK management in a timely basis
- Supports the preparation, coordination, and management of regulatory agency Preapproval or regular inspections.
- Support regulatory inspections at contract sites involved in the project.
- Provides Quality Assurance leadership, guidance, and direction to CMOs consistent with cGMPs and GSK quality compliance.
- 8+ years' experience in the pharmaceutical/bio-pharm manufacturing industry with at least 3 of those years at the QA manager level
- Experience and working knowledge about the small molecules chemistry, tablets and capsules
- Working knowledge ICH quality guidance, EU and FDA drug manufacturing regulations
- Able to work a flexible work schedule to accommodate program priorities and international activities as needed
- US Work authorization is required. Sponsorship is not available.
- Ability to travel (includes international), 20%
- Experience in the operational Quality Management of (CMO) Contract Manufacturing Organizations producing products on behalf of another pharmaceutical company
- Good knowledge of GMP; Regulations and Quality aspects of managing CMOs and suppliers of Drug Substance and Drug Product
- Demonstrated capability on building effective relationships with CMOs
- Experience in GMP manufacturing and/or packaging operations
- Good Clinical Practice experience is a plus
- Experience with sterile formulation
- Competency in MS Office Products and Adobe Acrobat
Please use the cover letter to highlight how you meet the competencies for the role. Your cover letter along with your CV will be used to assess your application. Thanks for your interest in this opportunity.
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
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