RESPONSIBILITIES:
- Lead and manage QA/QC departments, including Quality Systems, Quality Control Laboratories, Document Control, and Compliance.
- Develop, implement, and maintain robust quality management systems in alignment with regulatory standards (cGMP, ISO 9001, FDA).
- Ensure compliance with all relevant regulatory requirements and serve as the point of contact for audits and inspections (e.g., FDA, USDA, ISO certifying bodies).
- Drive continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction.
- Oversee product release, change control, CAPA (Corrective and Preventive Actions), and deviation management.
- Lead internal audits and supplier qualification programs; manage external audit readiness and responses.
- Collaborate with cross-functional departments including R&D, Manufacturing, Supply Chain, and Regulatory Affairs to ensure quality objectives are integrated throughout the product lifecycle.
- Hire, train, and mentor QA/QC personnel; build high-performing teams.
- Monitor key quality metrics and report to executive leadership.
- Stay current on industry trends, emerging regulations, and best practices.
- Support Change Management Team
- Drive/Support Sustainability within QA/QC
- Participate in Safety Council with cross-functional team
- Develop Lab and Metrology methodology
Collaborate with Manufacturing/Assembly and align on continuous improvement
REQUIREMENTS:
- Bachelor's or Master's degree in Life Sciences, Food Science, Chemistry, Engineering, or a related field.
- 10+ years of progressive experience in QA/QC roles in Biopharma, Food & Beverage, or related regulated industry.
- 5+ years in a leadership role
- Strong knowledge of regulatory requirements (FDA, cGMP, ISO standards).
- Experience with laboratory operations, microbiological and chemical testing, and analytical method validation.
- Demonstrated success in leading regulatory inspections and audits.
- Demonstrated expertise within Metrology (CMM programming, Statistical Analysis)
- Excellent leadership, communication, and organizational skills.
- Lean Six Sigma or other continuous improvement certification is a plus.
In return, we offer you exciting and challenging responsibilities, diverse perspectives with a high degree of individual freedom and a corporate culture that encourages you to use it.
