Position Summary
Quality Senior Manager - Prescription Primary Packaging
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.
Key Responsibilities - Quality Management System (QMS)
- 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
- Regulatory & Customer Compliance
- Ensure compliance with:
- Customer-specific GMP requirements (pharma clients)
- U.S. Food and Drug Administration expectations for packaging suppliers (as applicable)
- Act as primary contact for:
- Customer audits and qualifications
- Regulatory inspections (as applicable)
- Ensure audit readiness at all times
- Product Quality & Release
- 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
- Customer Quality & Complaints
- 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
- Manufacturing Quality Oversight
- Partner with Operations for:
- Injection molding, extrusion, or thermoforming processes
- Process capability and control (Cp/Cpk)
- Scrap and defect reduction
- Ensure process validation (IQ/OQ/PQ) and ongoing process verification
- Supplier Quality Management
- Qualify and monitor raw material suppliers (resins, additives, components)
- Conduct supplier audits and performance reviews
- Ensure incoming material compliance with specifications
- Continuous Improvement
- Lead Lean / Six Sigma initiatives focused on:
- Defect reduction
- Yield improvement
- Cost of poor quality (COPQ) reduction
- Establish and monitor Quality KPIs (scrap, rework, complaints, audit findings)
- Team Leadership
- 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
- Risk Management
- Apply risk-based approaches (e.g., FMEA)
- Identify and mitigate product and process risks
- Ensure business continuity from a quality perspective
Qualifications
Education
- Bachelor’s degree in Engineering, Chemistry, Materials Science, or related field
Experience
- 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
Certifications (Preferred)
- ASQ CQE or CQA
- Lean Six Sigma Green/Black Belt
Key Skills
- 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
Key Performance Indicators (KPIs)
- Customer complaints (PPM, trends)
- Internal defect rates and scrap (CNQ%)
- CAPA effectiveness and closure time
- Audit results (customer and certification audits)
- New launch quality performance
- First acceptance (FA) and RFT (right first time)
- CRIT (complaint response in time)
Reporting Structure
- Reports to: Plant Manager / VP of Quality
- Direct reports: Quality System Manager and Quality Engineers
