Quality Manager - Manufacturing
Quality Manager - Manufacturing
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$ 80000 - 90000
1 Vacancy
Job Description
Responsibilities
- Oversee daily operations of the Quality Assurance (QA) and Quality Control (QC) departments.
- Ensure compliance with applicable FDA regulations (21 CFR Part 210/211 820 etc.) ISO standards and internal SOPs.
- Lead and manage audits and inspections by the FDA ISO registrars and customers.
- Develop implement and maintain the companys Quality Management System (QMS).
- Review and approve deviations CAPAs change controls and nonconformance reports.
- Monitor key quality metrics (e.g. batch failures complaints audit findings) and present trends to senior leadership.
- Oversee validation and qualification activities (e.g. equipment process cleaning and software validation).
- Support training programs to ensure staff are fully trained on quality procedures and GMP requirements.
- Collaborate cross-functionally with manufacturing R&D supply chain and regulatory affairs.
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
Requirements
- Bachelors degree in Life Sciences Engineering or related field (Masters preferred).
- Minimum 3 years of quality experience in an FDA-regulated manufacturing environment (e.g. pharmaceutical medical device biotech or food).
- At least 3 years in a management or leadership role.
- Strong knowledge of cGMP 21 CFR Part 210/211 or 820 and relevant FDA regulations.
- Experience with QMS implementation regulatory inspections and audit readiness.
- Excellent problem-solving and root cause analysis skills (e.g. CAPA FMEA 5 Whys).
Required Experience:
Manager
Employment Type
Full-Time
