Manager, Quality GMP
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Job Description
GMP Quality Manager overseeing quality management system in biopharmaceutical company. Ensuring compliance with regulatory standards and leading quality initiatives for continuous improvement.
Responsibilities:
- Oversee review and approval of batch records, analytical data, and supporting documentation.
- Ensure timely disposition of materials, intermediates, and finished products.
- Support investigations of out-of-specification (OOS), out-of-trend (OOT), and deviation events.
- Support qualification, periodic review, and auditing of GMP vendors.
- Review vendor and site quality issues, change control, deviations, and CAPAs.
- Support the planning, conduct, and follow up on internal GMP audits and GMP external vendor audits.
- Review audit schedules, reports, and CAPA tracking.
- Support the development and maintenance of GMP training programs for employees.
- Support the development, review and maintenance of SOPs.
- Support the development, implementation, and maintenance of the Quality Management System (QMS).
- Ensure compliance with GMP regulations, internal procedures, and industry standards.
- Manage document control, change control, deviation investigations, CAPAs, and product release processes.
- Track and analyze quality metrics to identify trends and opportunities for improvement.
- Lead quality improvement initiatives to enhance compliance, efficiency, and product quality.
- Implement risk management tools (e.g., FMEA, risk assessments) to support sound decision-making.
Requirements:
- Bachelor’s degree in life sciences, Engineering, Pharmacy or related discipline
- 5–8+ years of QA experience in biotech/pharmaceutical environment; experience in small biotech strongly preferred.
- Knowledge of GMP and working familiarity with GCP; GLP experience is a plus.
- Ability to work independently in a fast-moving, resource-lean environment.
- Ability to interpret global regulatory expectations (FDA, EMA, ICH).
- Prior involvement in inspection readiness or regulatory submissions.
Benefits:
- medical
- dental
- vision
- time off
- 401K
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