Senior Manager, Quality Operations jobs in United States
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West Leland Group · 19 hours ago

Senior Manager, Quality Operations

West Leland Group is partnering with a growth-oriented pharmaceutical manufacturing organization to hire a Senior Manager, Quality Operations. This site-based leadership role is responsible for overseeing Quality Assurance activities to ensure compliance with GMP expectations and internal procedures while leading quality improvements on the manufacturing floor.

Staffing & Recruiting
Hiring Manager
Jack Feeley
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Responsibilities

Lead Quality Assurance activities supporting compounding, filling, and packaging operations
Translate 21 CFR 210/211 requirements into practical, compliant execution on the manufacturing floor
Provide real-time quality leadership for equipment setup, line clearance, in-process checks, and batch execution
Exercise authority to stop production and escalate issues when GMP compliance, product quality, or safety is at risk
Lead investigations, root cause analysis, and corrective and preventive actions using structured problem-solving methods
Review and approve batch records, SOPs, deviations, CAPAs, and change controls
Partner with Operations, Maintenance, and Engineering to support validated processes and quality-first decision making
Coach and develop QA staff working directly on the manufacturing floor, reinforcing consistent expectations and accountability

Qualification

CGMP Quality experienceGMP requirements knowledgeLeadership in productionRoot cause analysisTechnical writing skillsCoaching QA staffEffective communicationProblem-solving methods

Required

Bachelor's degree in a scientific or technical discipline
7+ years of cGMP Quality experience within a pharmaceutical manufacturing environment
Experience in a leadership role, with success leading teams in a production setting
Strong working knowledge of GMP requirements and quality systems, with the ability to apply them in real manufacturing conditions
Demonstrated ability to make independent quality decisions, manage escalation appropriately, and communicate effectively with Operations
Strong investigation capability and technical writing skills
Comfort supporting a continuous manufacturing environment with shared leadership responsibility

Benefits

Competitive compensation and benefits

Company

West Leland Group

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West Leland Group is a specialized search firm focused on recruiting Quality Engineering, Quality Systems, and Regulatory Affairs talent within the Medical Device industry.

Funding

Current Stage
Early Stage
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