Quality Senior Manager

Centor•Millersburg, OH

About The Position

The Quality Senior Manager is responsible for ensuring that all prescription primary packaging components meet stringent customer, regulatory, and internal quality requirements. This role leads the Quality Management System (QMS), ensures compliance with applicable GMP standards for pharmaceutical packaging, and drives defect prevention in high-volume manufacturing processes. The position serves as the primary interface with pharmaceutical customers, ensuring consistent product quality and regulatory compliance to protect patient safety.

Requirements

Bachelor’s degree in Engineering, Chemistry, Materials Science, or related field
7+ years in quality within pharma packaging, plastics, and/or Automotive manufacturing industry
Strong experience with lean manufacturing process, injection molding or plastics processing preferred
Proven experience with customer audits and quality systems
Expertise in structure root cause analysis and statistical tools
Leadership and cross-functional collaboration
Data-driven decision-making
Strong focus on dimensional, functional, and material compliance
Heavy emphasis on process capability, defect prevention, and risk assessment
Customer-facing communication skills
Ability to manage competing priorities
Strong knowledge of ISO 9001
Understanding of pharma customer expectations and GMP principles

Nice To Haves

ASQ CQE or CQA
Lean Six Sigma Green/Black Belt

Responsibilities

Lead and maintain a compliant QMS aligned with ISO 9001 and International Organization for Standardization (GMP for primary packaging materials)
Oversee deviations, CAPA, and change control, document control and training systems
Ensure strong data integrity practices
Ensure compliance with customer-specific GMP requirements (pharma clients) and U.S. Food and Drug Administration expectations for packaging suppliers (as applicable)
Act as primary contact for customer audits and qualifications, and regulatory inspections (as applicable)
Ensure audit readiness at all times
Oversee incoming, in-process, and final inspection/testing
Ensure conformance to specifications (dimensions, functionality, visual defects, material properties)
Approve Certificates of Analysis (CoA) / Certificates of Conformance (CoC)
Manage non-conforming materials and product disposition
Lead investigation and resolution of customer complaints
Perform root cause analysis and implement effective CAPA
Track customer quality KPIs (CNQ%, complaints, PPMs)
Drive customer satisfaction and continuous improvement
Partner with Operations for injection molding, extrusion, or thermoforming processes, process capability and control (Cp/Cpk), and scrap and defect reduction
Ensure process validation (IQ/OQ/PQ) and ongoing process verification
Qualify and monitor raw material suppliers (resins, additives, components)
Conduct supplier audits and performance reviews
Ensure incoming material compliance with specifications
Lead Lean / Six Sigma initiatives focused on defect reduction, yield improvement, and Cost of Poor Quality (COPQ) reduction
Establish and monitor Quality KPIs (scrap, rework, complaints, audit findings)
Lead Quality System Manager, Quality Engineers, Technicians, Auditors, and Lab personnel
Develop team capabilities and training programs
Promote a strong quality culture across production and support functions
Apply risk-based approaches (e.g., FMEA)
Identify and mitigate product and process risks
Ensure business continuity from a quality perspective