Vice President, Biologics Quality

vor 3 Wochen

Boudry, Schweiz Bristol Myers Squibb Vollzeit

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

**Position Summary**

In support of the Chief Quality Officer, define and shape the Quality strategy for the Bio Sterile Manufacturing Quality Network, internally and externally, to ensure a high level of cGMP compliance and the safety, efficacy, and quality of all Bio and Sterile manufactured commercial products. Responsible for direction of the Quality Operations teams supporting Manufacturing, Laboratory operations and releasing or certifying of all BMS’s products produced, including internal and external manufacturing.

This role will ensure consistency and alignment in the overall Bio/Sterile Network Strategy and operational performance. The role will be part of the Global Quality Leadership Team (GQLT), the Biologics Operations Unit Leadership Team and will manage a team of Managers of others, including the Site Quality Heads of internal manufacturing sites, and other Quality Leaders responsible to enable quality activities critical to compliance and network related projects. This role will require strong collaboration with the Global Manufacturing, Supply Chain and SB&E functions.

Drive significant impact to current and future business performance and network strategies, through building a functionally excellent infrastructure (knowledge, processes, and systems) to handle moderate to high complexity quality and compliance responsibilities to ensure quality.

Recognizes the current context of where we are (run the business) and future actions and ensure the organization can operate in a compliant and effective way to maintain continuity of supply.

**Key Responsibilities**
- Supports the development, direction, and execution of the Quality Strategy for the Bio/Sterile Manufacturing Organization.
- Provides leadership direction for a multi-functional group of quality professionals, aligned with company culture that recognizes market practices and regulatory trends to achieve a uniform Quality strategy, as well as other Senior Quality Leaders responsible to enable quality activities critical to compliance and network related projects.
- Ensures that a robust and effective quality management system is implemented according to the global standards, to achieve the quality objectives of the Bio/Sterile Manufacturing operations.
- Progresses on the suitability and effectiveness of the quality management system and GMP compliance through participation in the required quality management reviews.
- Deploys Quality Risk Management Techniques for quality oversight and problem resolution to mitigate risk in conjunction with BMS Manufacturing/Supply management and Quality.
- Manages/supports the resolution of quality and technical problems within the Bio and Sterile organization in alignment with global standards, including Internal and external manufacturing.
- Supports audits and Health Authority inspections for the Bio / Sterile sites 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.
- Assures appropriate quality governance through performance of management reviews of quality KPI’s, metrics, process performance indicators and quality system signals and supply risks. Initiate corrective actions when necessary and perform follow-up on resulting measures.
- Ensures that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS (Quality Management System), with support from the global Quality Control team.
- Provides quality oversight and adequate resourcing where applicable within the Bio and Sterile organization for complex projects (transfers, launches, due-diligence, other) - providing support where needed to ensure compliance with the QMS, and to facilitate issues escalation and resolution.
- Coordinates and/or provides SME (Subject Matter Expert) input to for BMS Policies, Directives, SOPs related to quality compliance when required.
- Leads communication and develops effective strategies & partnership with stakeholders from Manufacturing, SB&E, Supply Chain, Regulatory, Project Management, and Operations.
- Builds strong organizational capability for current and future needs. Recruit and devel

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