Global Quality Control Operations

Description:

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.

Provides QC support as a subject matter expert for internal and external testing sites and product related inspections (e.g., Pre-Licensing Inspection (PLI) and periodic cGMP inspections).

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 indicators and quality system signals and supply risks. Initiate corrective actions when necessary and perform follow-up on resulting measures, with support from the local Pharma, Bio and Sterile organizations.

Support local Pharma, Bio, and Serile teams to ensure that GMP follow up actions for audit/inspection observations are tracked and actioned as per current QMS (Quality Management System).

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 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. Develop a high-performance culture within the Quality Control organization.

Coaches, leads and mentors direct reports and builds a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs.

Supports deployment of operational excellence strategies within Quality Control Network