Manager, Quality Management Systems

The Manager, Quality Management Systems is responsible for leading and managing the site’s Quality Management System (QMS) to ensure ongoing compliance with cGMP, FDA, and applicable regulatory requirements. This role provides oversight of core quality systems including deviations, investigations, CAPA, change control, document control, recalls, quality records governance, and related quality system processes. The Manager, Quality Management Systems serves as a key quality leader for QMS governance, inspection readiness, procedural compliance, quality metrics, and continuous improvement across the site. This position also partners closely with cross-functional departments to ensure quality systems are effective, timely, compliant, and aligned with operational and regulatory expectations.

Key Responsibilities:

• Lead and manage the site Quality Management System to ensure compliant, effective, and inspection-ready execution of core quality system processes.
• Oversee deviations, investigations, CAPA, change controls, document control, recalls, and quality records to ensure accuracy, completeness, compliance, and timely closure.
• Review and approve complex QMS records, ensuring robust root cause analysis, appropriate risk assessment, and effective corrective and preventive actions.
• Monitor and trend QMS metrics, backlogs, and recurring quality issues; communicate risks and recommendations to Quality leadership and site management.
• Establish, maintain, and continuously improve QMS procedures, workflows, and governance practices to strengthen compliance and operational effectiveness.
• Support internal audits, customer audits, and regulatory inspections by ensuring quality systems and associated records are inspection-ready at all times.
• Provide quality systems oversight for supplier-related quality processes, including supplier quality events, vendor notifications, quality record management, and linkage of supplier issues to deviations, investigations, CAPA, and change control systems, as applicable.
• Partner with Manufacturing, Packaging, Quality Control, Validation, Regulatory Affairs, Supply Chain, and Engineering to ensure appropriate application of QMS requirements across site operations.
• Lead, coach, and develop QMS personnel, including prioritization of work, performance oversight, and support for professional development.
• Support or lead the effective use and continuous improvement of the site electronic quality management system, with strong preference for MasterControl experience.

What We’re Looking For

Experience:

• 8–12 years of progressive Quality Assurance and/or Quality Systems experience in a cGMP-regulated pharmaceutical manufacturing environment.
• 3 years of leadership or direct management experience within Quality Systems, Quality Assurance, or a closely related quality function.
• Demonstrated experience owning or overseeing deviations, investigations, CAPA, change control, document control, recalls, and quality records management.
• Demonstrated experience supporting regulatory inspections, customer audits, and internal audits.
• Experience in oral solid dosage pharmaceutical manufacturing strongly preferred.
• Experience with electronic quality management systems required.
• MasterControl experience strongly preferred.

Education:

• Bachelor’s degree required in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or another related scientific or technical discipline.

Skills & Knowledge:

• Strong working knowledge of cGMPs, FDA regulations, and pharmaceutical quality systems, including 21 CFR Parts 210 and 211.
• Strong expertise in investigations, root cause analysis, CAPA, change control, document control, and quality systems governance.
• Excellent technical writing, documentation review, and organizational skills.
• Strong ability to analyze quality trends, manage competing priorities, and make sound risk-based decisions.
• Effective leadership, communication, and cross-functional collaboration skills in a regulated manufacturing environment.

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities
• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position (Monday–Friday, 8:00 AM – 5:00 PM)