Chief Quality Officer
About The Position
The Chief Quality Officer leads the development, implementation, and maintenance of quality management systems that comply with FDA regulations and GMP standards. The role oversees quality control processes, laboratory operations, supplier qualification, internal audits, regulatory compliance, and customer quality issues. It works closely with R&D and production teams to support product consistency and safety, leads and develops quality assurance staff, and represents the company with external organizations, auditors, and regulatory officials. The position also establishes quality metrics and strategy aligned with company objectives and prepares quality reports for senior management and regulatory bodies.
Requirements
- Bachelor’s degree or higher in a scientific field such as Food Science, Chemistry, Biochemistry, Engineering, or a related field.
- At least 15 years of experience in quality control or quality assurance in the dietary supplement or pharmaceutical industry, including at least 5 years in a managerial capacity.
- Deep understanding of FDA regulations (21 CFR Parts 111, 210, 211, and 11), GMP, HACCP, and ISO standards relevant to dietary supplements.
- Deep understanding of dietary supplement and pharmaceutical standards; experience in GRMA certification programs.
- Proven experience handling audits and maintaining compliance with regulatory bodies.
- Strong leadership skills and experience managing a quality assurance team.
- Excellent organizational, communication, and interpersonal skills.
- Knowledge of modern IT solutions for Quality Management Systems.
- Exceptional analytical and problem-solving skills.
- Ability to multitask and manage multiple projects simultaneously under tight deadlines.
- Strong attention to detail and commitment to delivering high-quality products.
- Proficiency with quality management software and tools.
Nice To Haves
- Master’s degree in a relevant scientific discipline.
- Quality management certifications, such as Certified Quality Auditor or Certified Quality Manager.
- Experience with lean manufacturing and continuous improvement processes.
- Experience managing laboratory operations.
- Experience managing external manufacturers and vendors.
- Proven track record in digitalization and transformation management.
- Experience implementing QMS.
- Experience with automation and in-line process controls.
- Proven track record in establishing effective teams.
- Experience creating and implementing quality strategy.
Responsibilities
- Lead the development, implementation, and maintenance of quality management systems in compliance with FDA regulations and GMP standards.
- Oversee quality control processes, including raw material verification, in-process quality checks, and finished product testing.
- Oversee laboratory operations.
- Manage and enhance the supplier qualification program to ensure raw materials meet quality and regulatory standards.
- Coordinate with R&D and production teams to implement quality standards and improve product consistency and safety.
- Lead internal audit programs, identify potential quality issues, and implement corrective actions in a timely manner.
- Maintain current knowledge of industry trends, new regulatory requirements, and quality management best practices.
- Train and mentor quality assurance staff and oversee their daily activities and performance.
- Manage customer relations related to product quality, investigate issues, and develop solutions to prevent recurrence.
- Prepare and present detailed quality reports to senior management and relevant regulatory bodies.
- Collaborate with external auditors and regulatory officials during inspections and provide necessary documentation.
- Serve as the Quality representative to external organizations.
- Establish key metrics and a Quality Strategy aligned with company objectives.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
