Position Summary
To define and shape the Quality strategy for global Contract Manufacturing Organizations (CMO) and associated Contract Test Labs (CTLs) management for the Cell Therapy External Manufacturing (ExM) network and to ensure a high level of cGMP compliance and the safety, efficacy, and quality of externally manufactured commercial products. This includes but is not limited to the following areas:
1) CAR T (Cell Banks, Plasmids, Vector, and Drug Product) manufacturing/ testing and evolving Gene Editing technologies for both clinical and commercial products.
2) Areas managed by BMS companies, e.g., 2Seventy Bio (testing) and Orbital Therapeutics (in vivo).
3) Patient Operations as it relates to global Apheresis Centers.
To lead a team of Quality Senior Directors or others in the oversight of the External Manufacturing Network. To build relationships with senior leadership in the CMO and CTL network to support the Virtual Plant Teams (VPTs) and Virtual Analytical Teams (VATs) and to proactively manage and improve CMO Quality performance through risk-based oversight and periodic reviews.
To drive significant impact on current and future business performance through building a functionally excellent infrastructure (knowledge, processes, and systems) to handle moderately complex quality and compliance responsibilities.
Duties/Responsibilities
Support Development of the Quality Strategy and the Quality Planning for the Cell Therapy External Manufacturing Organization and the Quality Global Business unit.
Owns the strategy of the Cell Therapy External Manufacturing Quality team.
Ensures all aspects of Quality Management of External Supplier/CMO is carried out according to the standards defined and is regularly reported and assessed for adequacy of performance.
Develop a high-performance quality culture with the Cell Therapy Vector and External Manufacturing Operations (VExMQ) organization
Builds strong organizational capability for current and future needs. Recruit and develop global talent to sustain local and global competitiveness. This includes identifying individuals with leadership potential, providing mentoring and enrichment opportunities consistent with succession planning.
Support deployment of operational excellence strategies within VExMQ
Prepare and manage VExMQ organizational budget
Ensures the Quality Assurance Agreements for Suppliers/CMOs are created and maintained according to GMP and requirements, that they are regularly reviewed and followed, and that they address the respective roles, responsibilities and requirements for all parties involved in the supply of the product.
Manage/support the resolution of quality and technical problems in alignment with global standards
Deploys Quality Risk Management Techniques for quality oversight and problem resolution for CMOs to mitigate unacceptable risk in conjunction with BMS Manufacturing/Supply management and Quality.
Support audits and Health Authority inspection for the CMOs as necessary, including the assistance in the generation of HA responses and CAPAs. Ensure that the all-critical and major issues, which may have an adverse effect on the quality of the product, or represent a risk of supply are escalated as per standard procedures to management and are resolved within stated timelines.
Assure appropriate quality governance through performance of management reviews of quality KPIs, metrics, process performance indicators, and quality system signals and ExM CMO supply risks. Initiate corrective actions when necessary and perform follow-up on resulting measures.
Ensure that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS
Provides oversight and resourcing where applicable within the VExMQ organization for projects (transfers, launches, due-diligence, other) 6 providing support where needed to ensure compliance with the QMS, and to facilitate issues escalation and resolution.
Coordinates and/or provides SME input to for BMS Policies, Directives, SOPs related to quality compliance when required.
Leads communication and develops effective strategies & partnership with stakeholders from MSQ, OPEX, Supply Chain, Regulatory, Project Management, and Operations.
Ensures improved oversight of onboarding and offboarding in the fast changing Life Cycle Management of CT products.
Ability to travel up to 25% (Domestic US and International).
Qualifications
Specific Knowledge, Skills, Abilities:
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.
Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end to end enterprise) and makes the best decisions for the whole
Excellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on behalf of the VP Cell Therapy Global Quality and interface with stakeholders in a matrix environment.
Uses judgment to make sound decisions based on information gathered and analyzed.
Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
Sets and maintains high performance standards. Pays close attention to detail, accuracy, and completeness.
Has a proven track record of delivering results and is action oriented.
Adapts to changing work environments, work priorities and organizational needs.
Plans and organizes tasks and work responsibilities to achieve objectives. Sets priorities. Schedules activities.
Education/Experience/ Licenses/Certifications:
Minimum bachelor6s degree in science or pharmaceutical related fields (Chem, Pham, Bio, Chem Eng). Advanced degree preferred.
Mastery of global Quality compliance processes and regulations, e.g., cGMP/GDP regulations for External Manufacturing QA.
A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations.
Thorough understanding of technical areas related to pharmaceutical and/or biological manufacturing, sterility assurance, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.
>15 years of experience managing Quality and Compliance organizations.
