Bachelor's Degree in a scientific field (Food Science, Chemistry, Biochemistry, Engineering, or related)
15+ years in quality control/assurance in dietary supplements or pharmaceuticals, with 5+ years in management
In-depth knowledge of FDA regulations (CFR 21 parts 111, 210, 211, and 11), GMP, HACCP, and ISO standards
Experience with GRMA certification programs
Proven audit and regulatory compliance experience
Strong leadership and team management skills
Excellent organizational and communication abilities
Familiarity with modern IT solutions for Quality Management Systems
Responsibilities
Lead the development and maintenance of quality management systems compliant with FDA and GMP standards
Oversee quality control processes including raw material verification and finished product testing
Manage laboratory operations and ensure compliance with quality standards
Enhance supplier qualification programs to meet quality and regulatory standards
Coordinate with R&D and production to improve product consistency and safety
Conduct internal audits to identify quality issues and implement corrective actions
Prepare and present quality reports to senior management and regulatory bodies
Benefits
Comprehensive health insurance
Retirement savings plan
Professional development opportunities
Flexible work schedule
Employee wellness programs
Full Job Description
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.
