Director of Quality, Orange

Director of Quality

27 Days Old

The Director of Quality is responsible for leading the Quality Assurance, Quality Control, and Regulatory departments to ensure compliance with applicable regulatory standards, including cGMPs, FDA requirements, and internal quality systems.

Job Title: Director of Quality
Location: San Bernardino County, California
Direct Hire
Pay: $165,000 to 180,000 Annually

Key Responsibilities

Develop and implement quality systems aligned with federal cGMP regulations for cosmetics and OTC drug products
Interpret and integrate regulatory requirements into manufacturing operations
Oversee creation and enforcement of quality policies, standards, SOPs, and strategic plans
Review and approve key documents including SOPs, product specs, BOMs, and validation records
Supervise the QA Supervisor, QC Manager, and Regulatory Manager, providing guidance and regular direction
Maintain and manage the customer complaint file, and ensure timely resolution
Lead internal quality audits and implement corrective/preventive actions
Respond to FDA observations and ensure full regulatory compliance
Maintain the OTC Master Drug List
Collaborate with suppliers, customers, and regulatory agencies on quality matters
Evaluate and approve supplier performance per established specifications
Measure performance against standards; drive continuous process improvements
Provide cross-functional training on customer and regulatory requirements
Attend external conferences and seminars to stay current on industry trends and regulations
Manage department budget and ensure cost-effective quality operations
Support all company policies and initiatives

Required Qualifications

Bachelor's degree in Biology, Microbiology, Chemistry, or Mathematics (Master's degree preferred)
10 years of experience in OTC drug manufacturing and quality
Minimum 5 years in a supervisory or management role in a regulated manufacturing environment
Strong knowledge of FDA regulations, cGMPs, validation, and quality system development
Proven experience with regulatory, third-party, and customer audits
Excellent organizational, problem-solving, and communication skills
Demonstrated leadership in people development, strategic planning, and cross-functional collaboration
Experience with manufacturing operations, technical documentation, and statistical analysis

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

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Location:: Orange

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