Pharma COE QMS Director



 We are the people who give possibilities purpose 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 MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 Job Description We are the makers of possible 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 MedTech 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. Experience Minimum 10 years in Quality Management at Manager or Director level, with substantial pharmaceutical GMP experience. Scope Owns and executes defined central QMS processes across the network; contributes to the overall QMS strategy. Inspections Leads inspection readiness and supports front/back room during health authority inspections. CAPA/NC governance Drives on-time closure and quality of investigations and CAPAs; participates in network CAPA governance. People & capability Develops site quality staff through training, coaching and the community of practice; may lead a small central team. Influence 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 surveillance/pharmacovigilance interfaces; validation and qualification governance; calibration; and quality metrics and management review reporting. The successful candidate will bring a demonstrated track record of building, implementing and sustaining pharmaceutical quality systems that are substantially compliant with cGMP and international standards, operationally efficient, and effective in supporting business growth and regulatory expectations. Job Responsibilities (Primary Duties, Roles and/or Authorities) Pharmaceutical QMS Development and Implementation Defines and owns the central pharmaceutical QMS strategy and roadmap, including the architecture of the global quality manual, policies, standards, SOPs and supporting records structure for the COE. Designs, develops and implements harmonized quality system processes across the pharmaceutical network, driving one QMS in accordance with corporate strategy and eliminating site‑by‑site divergence where standardization adds value. Leads deployment of the QMS at new, acquired or transitioning sites and external manufacturing partners, including gap assessments, implementation plans, training and readiness verification. Ensures the QMS remains current with evolving GxP regulatory requirements and international standards, and that impacted procedures are revised, communicated and implemented on schedule. Drives digitalization and modernization of the QMS, including electronic quality management systems (e.g., Veeva Vault QMS, TrackWise), eDMS, LIMS, electronic batch records, and quality analytics platforms (Power BI, Qlik). Establishes the QMS governance framework — process ownership, decision rights, escalation paths, and periodic health checks — to ensure the system remains effective and audit‑ready at all times. CAPA, Nonconformance and Timely Closure Accountability Owns the central deviation/nonconformance, CAPA and change control processes; sets standards for investigation quality, root cause methodology, risk classification and effectiveness checks. Is accountable for on‑time closure performance of deviations, nonconformances, CAPAs, change controls and audit/inspection commitments across the network; defines targets, monitors aging and backlog, and escalates at‑risk records to site and COE leadership. Establishes and operates a network‑level CAPA governance/review board to challenge root cause depth, prevent recurrence, approve extensions on an exception basis only, and verify CAPA effectiveness. Performs trending and cross‑site signal detection on quality events; identifies systemic issues and directs network‑wide corrective and preventive action and continuous improvement initiatives. Drives remediation programs in response to internal findings, regulatory observations, warning letters or consent decree commitments, ensuring timely and sustainable resolution. Compliance, Audits and Regulatory Inspections Directs the internal audit and self‑inspection program for the pharmaceutical network, including schedule, auditor qualification, risk‑based planning, reporting and follow‑up to closure. Manages inspection readiness for FDA, EMA and other health authority inspections across manufacturing sites, development centers and external partners, including readiness plans, m