Quality Systems Manager
West Pharmaceutical Services
full-time
Posted on:
Location Type: Office
Location: Scottsdale • Arizona • 🇺🇸 United States
Visit company websiteJob Level
SeniorLead
About the role
- Manage the Quality Systems group which includes quality and customer projects as needed
- Support supervision of document control personnel and activities depending on the departmental needs
- Support corporate, internal, customer and regulatory audits, and customer notification of changes
- Improve the Quality Systems, ensure compliance with policies, procedures and regulations and perform activities to improve customer satisfaction
- Develop the infrastructure for the Quality Systems function, aligning with the strategic plan for Quality and for Global West business
- Ensure that the Quality System is current and meets the needs of the customer base and applicable Regulatory bodies and Quality Standards such as 21 CFR Part 820, ISO 13485, and EU/MDR Requirements
- Lead, manage, and develop the Quality Systems team by establishing clear goals, providing regular performance feedback, and supporting professional growth and development plans
- Oversee and review or approve investigations related to QMS elements such as audit findings, nonconformances (NCRs), CAPAs, and issue reviews
- Support the execution of quality strategic plans and policies for the Scottsdale site in alignment with corporate objectives
- Lead or participate in remediation and improvement initiatives that enhance the effectiveness and compliance of the Quality Management System
- Participate in investigations and corrective actions stemming from QMS audits or other continuous improvement activities
- Develop, implement, and deliver training programs related to QMS processes, compliance, and quality system improvements
- Identify, evaluate, and implement process improvements across QMS elements
- Prepare for and lead audits to ensure robust audit readiness and compliance
- Build and sustain a strong "culture of quality" through effective leadership, coaching, and cross-functional collaboration
- Monitor and maintain compliance with global quality and regulatory standards
- Establish, track, and analyze Quality Metrics to assess system performance, compliance, and opportunities for improvement
- Ensure that quality review boards operate effectively to monitor QMS health and progress
- Lead Management Review Meetings and monitor site-level Quality KPIs to drive data-based improvements
- Generate, review, and approve Quality Assurance documentation required to support customer relationships, product development, regulatory filings, and compliance verification activities
- Drive projects and initiatives focused on cost savings, QMS optimization, and compliance enhancement
- Manage and support Customer, Corporate, and Regulatory audits including pre-audit planning, backroom leadership, hosting, and post-audit corrective action follow-up
- Perform additional duties as assigned to support business needs and strategic quality goals
Requirements
- Bachelor's Degree in a science related field or equivalent experience required
- Minimum 8 years Quality experience required
- Minimum 3 years of supervisory/management experience required
- Must possess knowledge of regulatory and governmental guidelines and requirements (21 CFR Part 820, ISO 13485, EU-MDR, cGMP, GLP)
- Experience in the regulated industry such as pharmaceutical and medical device preferred
- Experience with SAP systems preferred
Benefits
- Supported by benefit programs
- Empower the physical, mental, emotional and financial health of team members and their families
- Committed to creating a healthier environment and planet through sustainability efforts
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Quality Management System (QMS)CAPANonconformance Reports (NCRs)Quality MetricsRegulatory complianceDocument controlProcess improvementAudit readinessTraining program developmentQuality Assurance documentation
Soft skills
LeadershipCoachingCross-functional collaborationPerformance feedbackProfessional developmentGoal settingCommunicationProblem-solvingAnalytical thinkingTeam management