Salary :
Activate JobCopilot
Salary: $80,000 - 90,000/year
We are seeking a highly experienced and detail-driven Quality Manager to lead quality assurance and quality control functions in an FDA-regulated manufacturing environment. The ideal candidate will ensure compliance with cGMP, FDA, ISO 13485 (if applicable), and other regulatory standards, while driving continuous improvement across the organization. This role is critical to ensuring product safety, efficacy, and regulatory readiness.
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 company’s 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
- Bachelor’s degree in Life Sciences, Engineering, or related field (Master’s 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).
$80,000 - $90,000 a year
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