RoleSenior Manager, Quality Compliance, External Manufacturing – 12 month fixed term contract.Duties / ResponsibilitiesQuality Compliance: Lead Continuous Improvement and/or Compliance projects supporting the External Manufacturing (ExM) or network.Serve as Local Process Owner with responsibility for assigned Quality Systems (e.g., Change Control, Deviations, CAPA, Complaints), ensuring procedures, training, metrics, and compliance are maintained.Serve as Lead Site Change Champion with responsibility for manufacturing launches and high complexity CMO technical transfer projects.Lead the BMS Fact Finding Information Team (FIT) and Fact-Finding Information Review Meeting (FIRM) processes for major investigations involving ExM manufacture.Support the Product Action Committee (PAC) process for all recalls associated with CMOs managed by ExM.Support issuance of Health Authority (HA) notifications (e.g., Field Alert Reports) where required.Raise Notifications to Management (NTMs) for major and critical investigations where required.Review and approve responses to Health Authority (HA) observations prepared by CMOs to ensure regulatory alignment.Write and/or review Standard Operating Procedures (SOPs) and other controlled documents to ensure compliance with BMS standards and cGMP requirements.Represent ExM on global quality teams, initiatives, and cross-functional projects, providing quality/compliance subject matter expertise.Leadership & Process OwnershipWhere applicable, lead and develop direct reports; build a high-performance team culture and strong cross-functional relationships.Own all elements of the process including relevant procedures/forms, training materials, share point content, and metrics where applicable.Be primary subject matter expert for review of regulatory or directive changes.Regularly review the process for effectiveness and escalate compliance risks to senior management.Serve as the subject matter expert in audits / inspections.Develop and implement pro-active continuous improvement plans for the process.Support Annual Product Reviews/APQRs, vendor approvals, bona fides, and stability protocol updates, where applicable.Qualifications, Knowledge and Skills RequiredBSc or equivalent in a scientific discipline such as Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy.8-10+ years of experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory Affairs, or within a Health Authority agency.Extensive technical knowledge of chemical, biological, and/or pharmaceutical operations with firsthand experience in manufacturing, quality control, quality assurance, regulatory sciences, and R&D interfaces.In-depth knowledge of cGMP and GDP regulations for the USA, EU, and other international markets.Direct experience interacting with Health Authorities (e.g., FDA, EMA) and supporting or leading inspections.Direct experience working with external manufacturers and providing quality oversight at CMO sites.Strong analytical and problem-solving skills.Strong negotiation, communication, presentation, and interpersonal skills.Ability to build relationships and influence or enforce quality decisions at internal and external sites.Strong project management capability.Ability to balance business requirements with scientific and quality decision-making.Highly detail-oriented with strong organizational and follow-up skills.Ability to work independently with minimal supervision.Comfortable working in a fast-paced environment with dynamic timelines.Ability to lead, coach, and motivate team members across geographically dispersed locations.Strong collaboration and facilitation skills across multiple functional groups.Self-motivated with the ability to manage and prioritize multiple projects simultaneously.Ability to achieve targets and adapt to changing business priorities.Strong presentation skills and confidence in public speaking.Travel requirement typically approx. 10% but up to 25%, depending on business need.Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.Other informationIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.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. For field-based and remote-by-design roles, travel to visit customers, patients or partners and to attend meetings 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 accommodation prior to accepting a job offer. Inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for our Equal Employment Opportunity statement.Data Protection: We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe information is missing or incorrect, contact TAEnablement@bms.com with Job Title and Requisition number. For status inquiries, use Chat with Ripley.
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