Head of Biologics Quality Internal Sites
- Provides quality support and leadership to internal biological manufacturing network and testing laboratories. Owns responsibility for all regulatory and compliance activities within the biologic network and leads a quality organization of ~400 employees.
- Creates and maintains a high level of commitment to quality and compliance. Understands the regulatory environment and works proactively to assure that the state of the industry is anticipated and maintained.
- Assures the Quality Unit responsibilities described in BMS-Corporate Policies and GMS Policies and Directives are fulfilled.
- Communicates effectively and builds cooperative and supportive working relationships with all sites in the supply chain on technical, and quality matters. Interfaces with members of the Operations LT and QLT Management Teams.
- Maintains positive relationships inside and outside of the Company, including regulatory agencies and BMS business partners and suppliers. Proven ability to lead and motivate employees in all operational areas of the Company.
- Leads and develops staff to achieve professional growth and attain established goals and a robust succession plan. Develop remedial action for staff whose performance does not meet standards.
- Manages through direct report the Quality and Compliance functions at Devens, MA Syracuse, NY, Manati, PR, and Cruiserath, Ireland.
- Oversees and owns the execution of the Global Biologics Testing Strategy (capability and capacity) in the Cruiserath (GBL) and Devens (GSL) testing facilities.
- Develops/revises policies and directives and other quality system business processes as assigned.
- Reviewer and/or advisor for methods and specifications for biological products.
- Implements policies and procedures consistent with regulatory compliance. Ensures adherence to QC/QA procedures, policies and guidelines.
- Implements systematic corrective and/or preventive action plans. Anticipates regulatory trends and establishes systems to minimize GMP compliance impact to each site and the Company.
- Assures the timely escalation of significant events through the Notification to Management process.
- Leads or oversees fact finding and other investigations and makes recommendation for escalation of issues and events to the Product Review Committee for consideration of market action.
- Maintains oversight of departmental spending and head count. Reviews budget and conducts oversight of periodic projections of spending against budgets. Determines merit salary actions for staff and assures timely staff adherence to performance management deliverables.
- Develops, leads, and motivates an empowered high-performing team of change champions capable of delivering extraordinary performance and proactively fostering a culture where everyone owns quality. Enables aligned decision-making, rapid launch, and reliable delivery of ongoing drug supply.
- Participates and contributes to site and above site Quality Councils and Site Business Reviews to ensure Management with executive responsibility is appropriately informed and aware of the suitability and effectiveness of the quality system and significant events.
- Ensures that sites are inspection-ready at all times and attends site inspections as required.
- Oversees the generation of written response to regulatory inspection findings and submits to Head of Key Brands and Manufacturing Quality for review and endorsement as outlined in approved procedures.
- Ensures potential reportable problems (e.g., BPDR, QDN) are identified and reported to global health authorities as required. Oversees the generation of the regulatory report and submits for review and endorsement as outlined in approved procedures.
- Minimum of 20+ years of pharmaceutical manufacturing experience, with demonstrated experience in QC, QA, Validation and Process/Analytical methods supporting biological drug substance and drug products.
- Undergraduate degree in science required
- Advanced degree in a science or engineering discipline is preferred.
- Extensive knowledge and experience in the development and commercialization of biological drug products, including manufacturing, quality control and global regulatory strategies necessary for appropriate decision making and representation to regulatory agencies.
- Experience as the quality leader for a commercial manufacturing site and ideally also having experience in a headquarters/regional leadership role. More broadly, the successful candidate understands the business and marketing aspects of biological product operations and a highly regulated industry, as well as the relevant implications in evaluating the potential impact of product decisions.
- Prior responsibility for managing a large budget, and achieving profit and loss objectives.
- Significant experience with FDA and EMA regulatory authority interactions, including PAI & GMP inspections.
- Demonstrated technical expertise in BDS and biological drug product manufacturing and control strategies with aseptic experience that extends to finished drug product. Experience with combination drug products preferred.
- Ability to build strong relationships, lead large, complex organizations, and work across diverse cultures.
- Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
- Proven influencing and negotiating skills for interface with regulators.
- Strong project management and execution skills, and is able to manage multiple projects and prioritize as needed. Ability to plan and conduct projects within a multi-disciplinary environment.
- In-depth experience in managing large teams, and in providing coaching, development and mentoring to employees
- Position requires 30-60% travel.