Pharma COE QMS Director

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker
of possible with us.

Minimum 10 years in Quality Management at Manager or Director level, with substantial pharmaceutical GMP experience.

Owns and executes defined central QMS processes across the network; contributes to the overall QMS strategy.

Leads inspection readiness and supports front/back room during health authority inspections.

Drives on-time closure and quality of investigations and CAPAs; participates in network CAPA governance.

Develops site quality staff through training, coaching and the community of practice; may lead a small central team.

Influences site quality and operations leaders to adopt central standards.

Director, Quality Management Systems (QMS), Pharmaceutical Center of Excellence (COE) — level to be determined based on candidate experience — reports to the Vice President of Quality Management and is a member of the Pharmaceutical COE Quality Leadership Team. This is a central, enterprise-facing role accountable for the design, development, implementation and sustained effectiveness of a harmonized pharmaceutical Quality Management System across all sites, affiliates and contract manufacturing partners within the COE network.

The role defines and executes the central QMS strategy for the pharmaceutical portfolio, translating GxP regulatory expectations into a single, standardized set of quality system processes that are compliant, efficient, scalable and fit for purpose. The incumbent serves as the enterprise process owner for the pharmaceutical QMS and is the primary representative of the COE in corporate quality system initiatives, regulatory inspections and compliance governance forums.

A core accountability of this role is driving timely, high-quality closure of deviations/nonconformances, CAPAs, change controls and audit/inspection commitments across the network — including effectiveness verification — and building the capability of site quality staff so that quality system ownership is sustained locally.

The scope of responsibility includes end-to-end oversight of the pharmaceutical Quality System, including but not limited to: management responsibility and quality planning; deviation and nonconformance management; CAPA; change control; internal audit and self-inspection; regulatory inspections; customer, partner and supplier/external manufacturer audits; supplier and purchasing controls; document and records control (including data integrity);
GxP training and qualification; product quality reviews and annual product quality reviews; risk management; complaint management and post-market…