Sr Quality Manager, QMS

Required Skills

Experience

• Minimum of 10 years of Quality experience in pharmaceutical and/or medical device manufacturing, with pharmaceutical experience strongly preferred.
• Minimum of 5 years in leadership roles with direct people-management or quality-system governance responsibility.
• Demonstrated experience leading complex investigations, CAPA programs, and Change Control in a regulated manufacturing environment.
• Experience supporting FDA or other regulatory inspections and remediation activities, including responses to Form FDA 483 observations or Warning Letters, preferred.

CAPA System Leadership

• Lead site governance for CAPA initiation, risk-based prioritization, action planning, implementation, extension management, verification of effectiveness, and closure.
• Ensure CAPAs address verified root causes, include measurable deliverables, define accountable owners and due dates, and are sustainable across affected processes and products.
• Chair the site CAPA Review Board, challenge weak actions, escalate aging or high-risk records, and drive timely removal of barriers to execution.
• Ensure effectiveness checks use objective acceptance criteria, appropriate monitoring periods, and sufficient evidence to demonstrate recurrence control.
• Assess CAPA trends and systemic effectiveness, including recurrence, overdue actions, extensions, and cross-site or cross-functional applicability.

Change Control Governance

• Own and enhance the site Change Control process from proposal and impact assessment through approval, implementation, effectiveness verification, and closure.
• Ensure changes are evaluated for impact to product quality, patient/user safety, regulatory filings, validated state, facilities, equipment, computerized systems, procedures, training, suppliers, and business continuity.
• Partner with Regulatory Affairs to determine regulatory reportability of changes (Prior Approval Supplement, CBE-30, CBE-0, or Annual Report) under 21 CFR 314.70 and ICH Q12, and ensure no change is implemented before required regulatory approval.
• Ensure implementation plans identify prerequisites, testing, validation, documentation, training, regulatory actions, and post-implementation monitoring before the change becomes effective.
• Lead cross-functional change review forums and ensure changes are properly classified, approved by required functions, implemented as authorized, and closed with objective evidence.

Quality System Performance and Compliance

• Define and monitor leading and lagging metrics for NCI, CAPA, and Change Control, including timeliness, aging, recurrence, right-first-time quality, effectiveness, and implementation performance.
• Use data-driven analysis and quality risk management to identify systemic gaps, prioritize remediation, and communicate quality-system health to site leadership and management review.
• Serve as the site Subject Matter Expert for NCI, CAPA, and Change Control during internal audits, regulatory inspections, and responses to observations or commitments, including execution of CAPAs tied to Form FDA 483 observations and Warning Letter remediation.
• Maintain procedures, workflows, training, role clarity, and governance mechanisms that support consistent and sustainable execution.
• Work directly with the Pharma COE QMS Director to align site NCI, CAPA, and Change Control processes with COE and enterprise QMS standards; escalate systemic issues; implement COE-led harmonization and process improvements; and share lessons learned across Pharma COE sites.

Leadership and Cross-Functional Execution

• Lead, coach, and develop Quality personnel responsible for investigations, CAPA, and Change Control.
• Establish clear accountability, decision rights, escalation pathways, and execution discipline across record owners and approvers.
• Partner with functional leaders to ensure adequate resources, technical expertise, and timely completion of high-risk quality-system activities.
• Foster a culture of transparency, rigorous problem solving, proactive risk reduction, and continuous improvement.