Vice President, Global Quality Control Operations
Vor 4 Tagen
**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**
Reporting to the Chief Quality Officer, the Vice President, Global Quality Control and Analytical Sciences defines and shapes the Quality Control strategy for the internal and external QC Network, ensuring a high level of cGMP compliance and the safety, efficacy, and quality of all Pharma, Bio and Sterile manufactured commercial and clinical products.
Leads all aspects of end-to-end QC operations, testing, and compliance for raw materials, drug substance, and drug product. Accountable for ensuring ongoing clinical and commercial testing, as well as supporting new product introductions and life cycle management to enable advancement of the pipeline, globalization and company strategy.
Accountable for the development, implementation, and ongoing support of QC business systems and activities. This individual will lead our network of internal and external QC laboratories globally, and collaborate with other teams at BMS (e.g., Product Development, Manufacturing Sciences and Technology, Digital/IT, QA, Manufacturing, and Regulatory organizations) to provide strategic direction and guidance on world-class end-to-end QC operations and programs.
**Key Responsibilities**
- Leads the development, direction, and execution of the Quality Control Strategy for the Bio/Sterile and Pharma Organization. Provides leadership direction for a multi-functional group of quality professionals, aligned with Quality mindset and culture that recognizes market practices and regulatory trends to achieve a uniform Quality Control strategy, as well as other Senior Quality Leaders responsible to enable quality activities critical to compliance and network related projects.
- Responsible for safety, compliance, strategic planning, capacity and resource analysis, equipment utilization, and ensuring consistent and harmonized day-to-day operations of BMS QC cGMP Laboratories.
- Establishes and oversees testing program requirements for internal and external QC testing for Analytical Chemistry, Bioassay, and Microbiology functions in support of raw material, in-process, drug substance, and finished product for overall day to day testing operations.
- Assists in development and implementation of appropriate policies and standard operating procedures, digital systems, laboratory data collection and documentation systems and training of personnel to ensure cGMP compliance.
- Oversees QC laboratory investigations, change controls, deviations including resolution of Out of Specifications (OOS) and Out of Trends (OOT) observations, and CAPAs for relevant QC operations and ensure knowledge sharing across the QC laboratory network.
- Supports lifecycle management, globalization and CMC deliverables including content authoring and review of Quality owned sections for INDs/IMPDs, BLAs/MAAs and Health Authority information requests and communications and ensure robust analytical control strategy and data package for supporting regulatory filings.
- Owns and drives optimization of laboratory processes and systems to improve organization effectiveness; drives compliance at both internal and external laboratories to meet and exceed all BMS standards and global regulatory requirements
- Champions innovation and optimization of Global Laboratory systems including **development of technology and digital roadmaps **and strategic growth.
- Establishes and manages QC budget and maintaining control of costs;
- Deploys Quality Risk Management Techniques for quality oversight and problem resolution to mitigate risk in conjunction with BMS Manufacturing/Supply management and Quality.
- Owns the resolution of quality and technical problems within the Pharma, Bio and Sterile organization in alignment with global standards, including Internal and External manufacturing, with support from the local sites.
- Supports audits and Health Authority inspections for the Pharma, 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.
- Owns and drives appropriate quality governance through performance of management reviews of quality KPI’s, metrics, process performance
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