Senior Manager, Quality Operations
Posted 1 month ago Expired
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Upload Your ResumeAbout This Role
This is a site-based leadership role responsible for overseeing Quality Assurance activities that support compounding, filling, and packaging operations within a pharmaceutical manufacturing organization. This manager will serve as a key quality leader on the manufacturing floor, ensuring day-to-day execution remains compliant with current Good Manufacturing Practices (GMP) and internal procedures.
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
Requirements
- 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
- Demonstrated ability to make independent quality decisions, manage escalation appropriately, and communicate effectively with Operations
- Strong investigation capability and technical writing skills
Qualifications
- Bachelor’s degree in a scientific or technical discipline
- 7+ years of cGMP Quality experience within a pharmaceutical manufacturing environment, with leadership experience leading teams in a production setting.
Skills
* Required skills
Benefits
About West Leland Group
West Leland Group is a boutique search firm focused on Quality, Regulatory, and Medical Affairs roles for medical device, biotech, and pharmaceutical companies. They are managing this search on behalf of a client company.