Quality Manager (Manufacturing)
- Lead, develop, and monitor the performance and growth of the Quality Assurance team, including staffing, training, coaching, and performance evaluations.
- Promote an inclusive, collaborative culture where “everyone owns quality” and team members are empowered to contribute to product excellence and compliance.
- Manage the Quality Management System (QMS) in compliance with ISO 22716, ISO 9001, FDA regulations, and customer requirements; ensure systems are audit-ready at all times.
- Oversee internal audits, deviations, CAPAs, change control, document control, and validation activities to ensure robust quality systems and continuous improvement.
- Serve as the primary quality and regulatory contact for internal teams, customers, and regulatory bodies, lead responses to customer complaints, audits, and inspections.
- Liaise with customers on product quality, new product introductions, specification alignment, and resolution of quality concerns.
- Partner cross-functionally with Production, Supply Chain, Regulatory, R&D, and the Lab Manager to solve problems, reduce defects, and improve product and process quality.
- Monitor and analyze KPIs and quality data to drive operational excellence and meet product performance expectations.
- Ensure compliance with cGMP, GLP, Good Documentation Practices, and internal policies; stay current on regulatory changes and implement updates as required.
- Drive strategic quality initiatives, including cost reduction, efficiency improvements, and risk mitigation, in alignment with company goals and customer expectations.
- Own product release decisions for raw materials, bulk formulations, and finished goods in partnership with the Lab Manager and senior leadership.
- Support supplier quality management, including specification flow-down, qualification, monitoring, and corrective actions for nonconforming materials.
- Represent the Quality function in customer, corporate, and regulatory interactions, lead audit readiness and inspection preparedness efforts.
- Develop and manage departmental budgets, resource plans, and capital needs in alignment with operational and compliance priorities.
- Bachelor’s degree in relevant fields such as Life Science, Engineering, Chemistry, or related discipline required.
- Minimum of 5 years of experience in quality assurance or a life sciences role (e.g., analytical, microbiological) within a manufacturing environment.
- At least 5 years of management experience or a combination of 7+ years of supervisory and leadership experience.
- Experience working in a regulated environment with strong working knowledge of FDA, EPA, ISO 22716, and other applicable regulatory frameworks.
- Proven track record of leading cross-functional teams and developing talent within a
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