Senior Quality Manager – Drug Products

About the role

We lead plant-wide Quality programs and compliance activities, overseeing CAPAs, non-conformances (QNs), planned deviations, and internal audit readiness across multiple departments. We drive Quality oversight for change control and engineering initiatives within the Drug Products function, ensuring alignment with regulatory and internal standards. We serve as a key member of the Quality Leadership Team, ensuring site compliance with procedures, regulatory requirements, and industry standards for medical device and pharmaceutical manufacturing.

Responsibilities

• Lead plant-wide Quality programs and compliance activities, overseeing CAPAs, non-conformances (QNs), planned deviations, and internal audit readiness across multiple departments
• Drive Quality oversight for change control and engineering initiatives within the Drug Products function, ensuring alignment with regulatory and internal standards
• Serve as a key member of the Quality Leadership Team, ensuring site compliance with procedures, regulatory requirements, and industry standards for medical device and pharmaceutical manufacturing
• Champion continuous improvement initiatives as part of the Quality Steering Committee, driving quality system enhancements and supporting departmental and site-wide goals
• Contribute to operational excellence projects, including blitzes, Six Sigma, and cross-functional improvement initiatives
• Own Annual Product Reviews (APRs), ensuring thorough evaluation of product quality and compliance performance
• Analyze quality data and trends to proactively identify risks and initiate improvement projects that address gaps and deficiencies
• Empower and coach Quality teams, fostering a culture of accountability, continuous improvement, and compliance excellence
• Partner cross-functionally with Quality, Production, and Engineering teams to identify root causes of quality issues and implement effective corrective actions
• Prepare and deliver presentations for management reviews and site forums, ensuring clear communication of Quality performance and key insights
• Lead and develop Quality team members, including engineers, technicians, and calibration staff, through:
• Regular one-on-one engagement
• Performance coaching and career development
• Workload prioritization and resource planning
• Negotiation and conflict resolution
• Act as a subject matter expert (SME) on QMS and drug product regulations, mentoring cross-functional teams on requirements, expectations, and best practices
• Serve as a delegate for the Plant Quality Associate Director, representing Drug Product Quality in cross-functional and site leadership discussions as needed
• Support external audit readiness and execution, including FDA, ISO, corporate, and customer audits
• Ensure full compliance with safety and environmental regulations, including RCRA hazardous waste requirements and all applicable BD policies
• Uphold quality assurance standards and practices, ensuring consistent application of sound Quality principles across all operations

Requirements

• Bachelor’s degree with 8 years relevant experience or a combination of equivalent education and experience
• Previous supervisory or management with 5 years relevant experience managing direct reports
• Previous GMP experience with 5 years in Pharmaceutical, Drug Product, OTC and/or Combination Product experience

Preferred qualifications

• Degree in Engineering or Life Sciences
• Six Sigma Certification

Knowledge and Skills

• Extensive application of technical principles, theories, concepts and quality sciences, tools and systems with measurable / confirmed results
• Track record of root cause determination and effective corrective / preventive action implementation
• Change management authorship, review, and/or approval
• Validation and qualification authorship, review, approval, and/or execution such as (Install/Operational/Performance Qualification (IQ/OQ/PQ), Test Method Validation (TMV), and Measurement Systems Analysis (MSA).
• Provides training for product development teams and continuous improvement teams on best practices
• Conducts audits as member of a quality system audit team (e.g. SME, etc…)
• Writes and leads risk management activities including risk management reports, risk assessment and risk analyses
• Working knowledge of ISO 13485, FDA 21 CFR 211 and 820, and GMP requirements.
• Root cause analysis methodologies (8D, A3, Fishbone, 5 Whys).
• Skilled in Minitab, SAP, and TrackWise (or other ERP/QMS software).