West Pharmaceutical Services · 1 day ago
Quality Systems Manager
Scottsdale, AZ
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expWest Pharmaceutical Services is a dedicated team focused on improving patient lives and has a long-standing history in the healthcare industry. The Quality Systems Manager will lead the Quality Systems group, ensuring compliance with policies and regulations while enhancing overall customer satisfaction through effective quality management practices.
BiotechnologyHealth CareIndustrialManufacturingPackaging ServicesPharmaceutical
Responsibilities
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, as needed, 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—including Document Control, Audits, CAPA, NCR, Deviation Management, Site QA KPIs, and Management Review
Prepare for and lead customer, corporate, and regulatory 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, including 21 CFR Part 820, ISO 13485, and EU MDR
Establish, track, and analyze Quality Metrics to assess system performance, compliance, and opportunities for improvement
Ensure that quality review boards—such as CAPA Reviews, Nonconformance Review Boards, and Audit Reviews—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
Qualification
Required
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)
Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of customer visits and business development related activities
Position operates in a professional office environment. May stand or sit for extended periods of time
Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
Read and interpret data, information and documents
Must maintain the ability to work well with others in a variety of situations
Must be able to multi-task, work under time constraints, problem solve, and prioritize
Ability to make independent and sound judgments
Observe and interpret situations, analyze and solve problems
Preferred
Master's Degree in a science related field preferred
Experience in regulated industry such as pharmaceutical and medical device preferred
Experience with SAP systems preferred
Strong knowledge and experience in Quality Systems in Medical Devices/Pharmaceuticals and/or Plastics Manufacturing
Demonstrated people skills specific to team building, problem solving, root cause analysis, and conflict resolution
Excellent presentation, writing, verbal, computer, interpersonal and communication skills
In depth knowledge of cGMP, cGDP, relevant ISO standards and medical device requirements
Familiarity with document management databases, particularly Master Control
Ability to adapt to frequent changes, unexpected events and still yield an effective outcome
Manages competing demands, makes timely and sound decisions, even under conditions of risk
Accepts feedback from others, ability to engender enthusiasm, motivate peers and subordinates and teambuilding
Effectively influences actions and opinions of others. Ability to perform effectively and efficiently in a fast-paced environment
Support and contribute to Lean Sigma programs and activities towards delivery of the set target
Able to comply with the company's safety policy at all times
Able to comply with the company's quality policy at all times
Company
West Pharmaceutical Services
West Pharmaceutical Services is a manufacturer of technologically advanced containment and delivery systems for injectable medicines.
5001-10000 employees
H1B Sponsorship
West Pharmaceutical Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (14)
2024 (24)
2023 (18)
2022 (26)
2021 (17)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Eric Green
President, CEO and Chair of the Board
Atul Patel
Vice President, Devices & Delivery Systems
Recent News
2025-12-06
Company data provided by crunchbase