Pharma COE QMS Director

. Own and execute defined central QMS processes across the network and contribute to overall QMS strategy .

Posted 10/1/2026full-timeUnited StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in Quality Management, particularly in the pharmaceutical industry, with a focus on developing and sustaining a harmonized Quality Management System (QMS) across multiple sites. Proven ability to lead teams, influence stakeholders, and ensure compliance with regulatory standards while driving continuous improvement initiatives.

Highest-signal resume keywords

Pharmaceutical QMS DevelopmentFDA-Regulated Industry ExperienceCAPA ManagementQuality Data AnalyticsProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management System (QMS)CAPADeviation ManagementRegulatory ComplianceQuality AuditingRisk-Based Decision MakingGMP StandardsDocument ManagementQuality ScorecardsKPI Frameworks

Soft Skills

Strong CommunicationProject Management SkillsCoaching and MentoringInfluencing Without AuthorityFacilitation Skills

Tools & Technologies

Veeva VaultTrackWiseElectronic QMSDocument Management PlatformsQuality Data Analytics Tools

Industry Keywords

PharmaceuticalBiologicsMedical DeviceGxP Requirements21 CFR Parts 210/211EU GMPISO 13485EudraLexICH Q7GAMP 5

Tech Stack

Tools & technologies

Vault

About the role

Key responsibilities & impact

Own and execute defined central QMS processes across the network and contribute to overall QMS strategy
Lead inspection readiness and support front/back room activities during health authority inspections
Drive on-time closure and quality of investigations and CAPAs
Participate in network CAPA governance
Develop site quality staff through training, coaching and community of practice
Lead a small central team as needed
Influence site quality and operations leaders to adopt central standards
Report to the Vice President of Quality Management and serve on the Pharmaceutical COE Quality Leadership Team
Design, develop, implement and sustain a harmonized pharmaceutical QMS across all sites, affiliates and contract manufacturing partners
Define and execute the central QMS strategy and roadmap, including global quality manuals, policies, standards, SOPs and records structures
Deploy the QMS at new, acquired or transitioning sites and external manufacturing partners
Maintain QMS alignment with evolving GxP requirements and international standards
Drive QMS digitalization using electronic QMS, document management, laboratory, electronic batch record and analytics platforms
Establish QMS governance, process ownership, decision rights, escalation paths and health checks
Own central deviation/nonconformance, CAPA and change control processes
Establish network-level CAPA governance and review
Perform quality-event trending and cross-site signal detection
Direct internal audit and self-inspection programs
Manage FDA, EMA and other health authority inspection readiness across sites and partners
Lead or support supplier, external manufacturer and customer audits
Oversee quality agreements and supplier qualification/purchasing controls
Support Quality, Legal and Regulatory Affairs teams with nonconformities and regulatory enforcement actions
Build site quality capability through training, coaching, mentoring and on-the-job development
Define competency standards and qualification requirements for quality system roles
Establish a cross-site community of practice
Support succession, rotational assignment and development planning
Lead, develop and retain the central QMS team
Design and maintain quality scorecards and KPI frameworks
Coordinate and conduct COE Management Review and track resulting actions
Report quality-system health, compliance risk and improvement progress to COE and corporate leadership

Requirements

What you’ll need

Bachelor's degree required in a scientific, engineering or related discipline
Advanced degree preferred
Minimum 10 years of experience in Quality Management at the Manager or Director level
Substantial pharmaceutical/GMP experience
Experience in pharmaceutical, biologics or medical device/health industry
Demonstrated experience building, implementing and sustaining a pharmaceutical QMS across multiple sites
Central/corporate or COE-level process ownership experience
Significant FDA-regulated industry experience, including supporting inspections and responding to Form 483 observations and warning letters
Proven track record driving timely closure and effectiveness of deviations, CAPAs and change controls at scale
Knowledge of US and international pharmaceutical regulations and standards, including 21 CFR Parts 210/211 and Part 11, EU GMP/EudraLex Volume 4 including Annex 1 and Annex 11, ICH Q7, Q8, Q9, Q10 and Q12, GAMP 5, and MHRA/PIC/S data integrity expectations
Familiarity with ISO 13485 and EU MDR/IVDR is an advantage for combination products
Experience with electronic QMS and document management platforms such as Veeva Vault and TrackWise
Experience with quality data analytics tools
Strong communication, presentation and project management skills
Ability to organize and manage multiple simultaneous projects effectively
Ability to make sound risk-based decisions and solve complex problems
Skilled facilitation for small and large groups, including health authority inspectors and executive leadership
Ability to coach and develop quality talent across sites
Ability to influence site and functional leaders without direct authority
Experience operating effectively in a matrixed environment
Ability to adapt to changing priorities and manage ambiguity

Benefits

Comp & perks

Supportive learning, growth and development environment
BD University investment and ongoing technology skills and expertise development
Inclusive, growth-centered and rewarding culture
Face-to-face collaboration supporting learning, progress and success