Quality Compliance Senior Manager

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Inspection Readiness & Risk Management

• Maintain permanent Audit readiness across ExM.
• Support self-inspections, internal audits, Health Authority inspections and/or Customer Audits at EXM sites as required.
• Lead or oversee self-inspection activities.
• Support the Policy Evaluation and Regulatory landscape (PEARL) program and Global Reg Observation evaluation (GROe).
• Provide quality oversight of CMOs (API, intermediates, biologics), including, Product Quality Complaints.
• Review/approve QMS documents and maintain controlled Document & Record Management systems.
• Represent ExM Quality on global or Local projects.
• Represent ExM during Health Authority inspections, including preparation activities and on-site support.
• Author responses to Health Authority inspection observations and review responses prepared by CMOs.
• Coordinate and track the annual CMO Risk Assessment (RA), ensuring timely completion.
• Support the development and monitoring of Quality Risk Mitigation Plans based on annual and interim RA triggers.
• Present risk, inspection, and audit trends, issues, and exceptions at ExM Quality Councils.

In addition, the Senior Manager, ExM Quality Compliance will:

• Where applicable, lead and develop direct reports; build a high-performance team culture and strong cross-functional relationships.
• Manage goal setting, performance, and development of team members where applicable.
• Own all elements of the process including relevant procedures/ forms, training materials, share point content, metrics where applicable
• Display technical knowledge of the process and understand risks/weaknesses in the system
• Responsible for ensuring the elements of the process are compliant with Regulatory requirements, Health Authority expectations and with BMS policies/directives where applicable
• Responsible for ensuring the elements of the process are current and reflect current practices
• Be primary subject matter expert for review of regulatory or directive changes, responsible for coordination of input from key stakeholders into the impact assessment to the process
• Regularly review the process (trends metrics, trends observations, right first time (RFT), Design, waste elimination) for their effectiveness and provide feedback to the Quality management team for action and remediation
• Own relevant process issues - speak to trends/issues/exceptions at ExM Quality Councils
• Own Health Authority commitments related to the process
• Serve as the subject matter expert in audits / inspections
• Develop and implement pro-active continuous improvement plans for the process for example Value Stream Mapping and identification of weak elements, regulatory surveillance
• Review process performance, lead remediation where needed, and escalade compliance risks to senior management.
• Support Annual Product Reviews/APQRs, vendor approvals, bona fides, and stability protocol updates, where applicable.

Key Responsibilities:

• Supports and manages assignments to simplify and improve processes and systems.
• Understands and applies industry regulations knowledge to an understanding of the business operation to achieve regulatory compliance.
• Identifies any gaps in the quality management system (QMS) and takes necessary actions to correct and improve.
• Improves the efficiency of the quality management system (QMS) by managing simplification initiatives throughout the organization.
• Contributes to developing and upholding the company's quality systems and processes.
• Confirms that the quality management system (QMS) aligns with specific regulatory requirements.

Qualifications, Knowledge and Skills Required:

• BSc or equivalent in a scientific discipline such as Natural Sciences, Chemistry, Microbiology, Biology, or Pharmacy.
• 8-10+ years' 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 oversigh