Senior Manager, GMP and QMS Quality Operations

The Manager of GMP and QMS Quality Operations provides strategic and operational support within GMP Quality and Quality Systems. This role involves leading training initiatives, vendor management, process improvement, and cross-functional collaboration to support Quality operations and compliance in a regulated industry.

Location: Remote (US)

Salary: $150,000–$175,000 USD

Responsibilities

• Support day-to-day operational quality oversight for manufacturing processes including batch record review, batch disposition, and manufacturing operations.
• Monitor operational activities and assess continuous improvement within QA operations.
• Serve as QA partner on change controls, CAPAs, deviations, OOS, and non-conformances.
• Facilitate root cause / A3 problem solving and partner with business on deviations/CAPAs.
• Draft, revise, review, and approve controlled documents including SOPs.
• Represent QA on cross-functional project teams and with external partners.
• Identify and anticipate trends in quality issues; collaborate on quality initiatives.
• Manage CSV oversight including planning and scheduling validation activities with external vendors.
• Ensure business partners assess and approve change controls for commercial processes.

Requirements

• Bachelor's degree in life science or related discipline.
• 7-10 years of experience in QA, QMS, QC, or Manufacturing in an FDA-regulated industry, preferably biologic therapeutics.
• Experience in all stages of clinical product development to commercialization.
• Direct experience with regulators (e.g., BLA, MAA submissions and/or inspections).
• Experience with Root Cause Analysis, data analytics, LEAN, DMAIC, Six Sigma.

Benefits

• Comprehensive benefits package including medical, dental, vision, 401(k), and more.
• Equity and annual target bonuses.
• Generous PTO and holidays.
• Wellness program with monthly stipend.
• Tuition reimbursement, management development, and mentoring programs.
• Cell phone allowance.

Additional Information

• Base salary range is $150K–$175K USD.
• The role emphasizes a culture of quality, continuous improvement, and cross-functional collaboration.
• The company values diversity, inclusion, and employee engagement.