Senior Manager API Quality Operations
This role is an 18-month contract for the BMS Global Quality External Manufacturing team.
Job Function
Provide quality operations and compliance oversight to active pharmaceutical ingredient (API) and intermediate contract manufacturing organisations (CMO) engaged by External Manufacturing within a cross-functional team.
Responsibilities
Proactively manage contract manufacturer relationships from a quality and compliance perspective; build strong effective working relationships with CMOs.
Lead quality for a Virtual Plant Team (VPT) or manage a significant portfolio at a CMO.
Develop and manage quality events, change control and market complaint programs for contract manufacturers; ensure an effective deviation management system to address vendor non-conformances from third-party suppliers.
Review process validation protocols and reports, and process verification/campaign reports for CMOs where relevant.
Implement Quality by Design (QbD) principles for all new products at CMOs; review and approve process risk assessment and process verification reports for intermediates and APIs.
Support pre-approval inspections.
Manage all activities associated with vendor approvals.
Provide subject-matter expertise to Supplier Relationship Management, Global Procurement, Supply Chain and Global M&S & T teams in support of new projects, technical transfer programmes, supplier selection programmes, investigations and validation programmes.
Provide requisite quality support to BMS functional groups such as Global Regulatory/Chemistry Manufacturing and Controls (CMC) and local country regulatory managers for regulatory filings, product renewals and regulator inquiries.
Manage quality metrics programmes in relation to CMO performance.
Serve as the Quality Operations Leader in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to third parties.
Prepare, negotiate and approve quality agreements and purchase specs with CMOs.
Review and approve annual product reviews submitted by CMOs; support the global BMS external auditing programme by participating in audits of third parties.
Provide information for quality council meetings.
Assess and implement corporate policies and directives.
Liaise with auditors of external vendors and suppliers; review vendor audits to identify trends and manage audit observation closure.
Review and update CMO Bona Fides as required.
Carry out annual risk assessments for CMOs.
Review and update stability protocols as necessary.
Proactively manage direct reports; review and approve goals and objectives; develop direct reports.
Carry out batch release as required.
Note
Travel will be required on a routine basis as part of this role (approximately 25 %).
Required Competencies
Five years' experience in the pharmaceutical industry, specifically in API manufacture, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency.
Extensive experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences, and interface with research & development.
In-depth knowledge of current Good Manufacturing Practices (cGMP) regulations pertinent to the United States of America (USA), European Union (EU) and other international markets.
Ability to build relationships, partnerships and influence and/or enforce quality decisions at external manufacturers.
Strong negotiation, communication and presentation skills across all levels both internal and external to BMS.
Exhibits BMS BioPharma Behaviours.
Strong analytical and problem-solving skills.
Why you should apply
You will help patients in their fight against serious diseases.
You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
You'll receive a competitive salary and a great benefits package including an annual bonus, pension contribution, family health insurance, 27 days of annual leave, access to on-site gym and life assurance.
On-site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work.
This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.
The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100 % of shifts onsite at your assigned facility.
Site-by-design roles may be eligible for a hybrid work model with at least 50 % onsite at your assigned facility.
For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive company culture.
For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
Supporting People with Disabilities
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.
Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.
If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to ******.
Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Candidate Rights
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Data Protection
We will never request payments, financial information, or social security numbers during our application or recruitment process.
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Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol Myers Squibb is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
Company: Bristol-Myers Squibb
Req Number: R*******
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