ExperienceMinimum 10 years in Quality Management at Manager or Director level, with substantial pharmaceutical GMP experience.
ScopeOwns and executes defined central QMS processes across the network; contributes to the overall QMS strategy.
InspectionsLeads inspection readiness and supports front/back room during health authority inspections.
CAPA/NC governanceDrives on-time closure and quality of investigations and CAPAs; participates in network CAPA governance.
People & capabilityDevelops site quality staff through training, coaching and the community of practice; may lead a small central team.
InfluenceInfluences 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, mock inspections and on-site inspection support.
- Leads or supports supplier, external manufacturer and customer audits, and oversees quality agreements and supplier qualification/purchasing controls.
- Supports Quality, Legal and Regulatory Affairs teams in responding to nonconformities and regulatory enforcement actions to drive timely resolution of issues.
- Promotes benchmarking of quality systems and compliance methodologies to implement best-in-class industry practices.
Development of Site Staff and Capability Building- Builds the quality system capability of site-based quality staff through structured training curricula, coaching, mentoring and on-the-job development in investigation writing, root cause analysis, CAPA management, risk management and data integrity.
- Defines competency standards and qualification requirements for quality system roles across the network and monitors capability gaps against them.
- Establishes a community of practice across sites to share standards, tools, lessons learned and improvement practices; drives consistency of execution network-wide.
- Supports talent planning for the quality function, including succession, rotational assignments and development plans for high-potential site quality personnel.
- Leads, develops and retains the central QMS team; builds a mission-driven, cohesive group and shares team successes across the organization.
Metrics, Management Review and Reporting- Designs and maintains the quality scorecard and KPI framework for the pharmaceutical network, including CAPA/NC on-time closure, backlog, repeat events, audit findings and training compliance.
- Coordinates and conducts Management Review for the COE, including collection and analysis of all data required, and tracking of resulting actions to closure.
- Provides regular, data-driven reporting on quality system health, compliance risk and improvement progress to COE and corporate leadership.
Education and Experience- Bachelor's degree required in a scientific, engineering or related discipline; advanced degree preferred.
- Minimum of 10 years of experience in Quality Management at the Manager or Director level in the pharmaceutical, biologics or medical device/health industry, with substantial pharmaceutical/GMP experience.
- Demonstrated experience building, implementing and sustaining a pharmaceutical QMS across multiple sites, including central/corporate or COE-level process ownership.
- Significant experience with FDA-regulated industry, including experience supporting inspections and responding to regulatory actions such as Form 483 observations and warning letters.
- Proven track record of driving timely closure and effectiveness of deviations, CAPAs and change controls at scale.
- Knowledge of US and international regulations and standards applicable to pharmaceutical products, 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 data integrity expectations (MHRA/PIC/S). Familiarity with ISO 13485 and EU MDR/IVDR is an advantage for combination products.
- Experience with electronic QMS and document management platforms (e.g., Veeva Vault, TrackWise) and quality data analytics tools.
- Strong communication, presentation and project management skills; able to balance a complex agenda, multitask, and remain well organized and methodical.
Knowledge and Skills- Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs.
- Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions.
- Decision Quality: Accurately assesses risk and clarifies ambiguous situations to make good decisions, developing alternatives with clearly documented consequences for each possible course of action.
- Communication Skills: Skilled facilitator for small and large groups and organizations, adapting content and style to engage the audience, including health authority inspectors and executive leadership.
- Action Oriented: Demonstrates a significant bias for action to execute key objectives, while actively seeking other opportunities to contribute.
- Coaching & Developing Others: Actively develops quality talent across sites through feedback, coaching and stretch assignments, raising the technical and compliance capability of the network.
- Courage & Independence: Seeks out and selects stimulating work with challenges, increasing scope and responsibilities; willing to hold the line on compliance standards.
- Composure: Responds constructively in stressful situations, including live inspections, and effectively calms others while taking action to resolve the root cause.
- Flexibility: Adapts plans to changing priorities, modeling and practicing key principles of change management.
- Process Effectiveness: Independently identifies the most efficient way to simplify and implement complex processes.
- Organizational Agility: Is cognizant of organizational culture in a matrixed environment and appropriately adjusts personal style to be effective; builds beneficial relationships inside and outside the organization.
- Influencing Others: Influences site and functional leaders without direct authority to adopt central standards and meet commitments; experienced at using multiple chains of influence to achieve broad organizational acceptance.
- Dealing with Ambiguity: Anticipates the organizational impact of change, rising to the challenge, applying ingenuity while accepting risk and uncertainty as normal.
- Building Effective Teams: Builds mission-driven, cohesive teams of people, sharing team wins and successes throughout the organization.
