Key Responsibilities:
- Lead the development, implementation, and maintenance of quality management systems in compliance with all FDA regulations and GMP standards.
- Oversee the entire quality control process, 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 required 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 to identify potential quality issues and implement corrective actions in a timely manner.
- Maintain up-to-date knowledge of industry trends, new regulatory requirements, and best practices in quality management.
- Train and mentor quality assurance staff and oversee their daily activities and performance.
- Manage the handling of customer relations related to product quality, investigating issues and developing 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 Quality representative to all external organizations.
- Establish key metrics and Quality Strategy in line with Company objectives.
Required Qualifications:
- Minimum Bachelor’s Degree in a scientific field such as Food Science, Chemistry, Biochemistry, Engineering, or related field.
- Minimum of 15 years’ experience in quality control or quality assurance in the dietary supplement or pharmaceutical industry, with at least 5 years in a managerial capacity.
- Deep understanding of FDA regulations (CFR 21 part 111, 210, 211 and 11), GMP, HACCP, and ISO standards relevant to dietary supplements.
- Deep understanding or dietary supplement and pharmaceutical standards – experience in GRMA certification programs.
- Proven experience in handling audits and 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 in the space of Quality Management System
Preferred qualifications:
- Master’s degree in a relevant scientific discipline.
- Certifications related to quality management (e.g., Certified Quality Auditor, Certified Quality Manager).
- Experience with lean manufacturing and continuous improvement processes.
- Experience in managing laboratory operations.
- Experience in managing External Manufacturers and vendors.
- Prove track record in digitalization and management of transformation.
- Experience in implementing QMS.
- Experience in automation and in-line process controls.
- Proven track record in establishing effective teams.
- Experience in creation and implementation of Quality strategy.
Skills:
- Exceptional analytical and problem-solving skills.
- Ability to multitask and manage multiple projects simultaneously under tight deadlines.
- Strong attention to detail and a commitment to delivering high-quality products.
- Proficient in using quality management software and tools.
