Astrix
Join to apply for the
Director of Quality
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Astrix 13 hours ago Be among the first 25 applicants Join to apply for the
Director of Quality
role at
Astrix 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.
Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description.
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!Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesIT Services and IT Consulting Referrals increase your chances of interviewing at Astrix by 2x Get notified about new Director of Quality jobs in
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Director of Quality
role at
Astrix 13 hours ago Be among the first 25 applicants Join to apply for the
Director of Quality
role at
Astrix 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.
Like the look of this opportunity Make sure to apply fast, as a high volume of applications is expected Scroll down to read the complete job description.
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!Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesIT Services and IT Consulting Referrals increase your chances of interviewing at Astrix by 2x Get notified about new Director of Quality jobs in
Orange County, CA . Sr. Director, Food Safety & Quality Assurance Newport Beach, CA $225,000.00-$275,000.00 5 days ago Director, Quality Initiatives (Director III) Orange, CA $192,386.00-$307,817.00 4 days ago Santa Ana, CA $150,000.00-$160,000.00 6 days ago Irvine, CA $178,022.00-$254,317.00 1 week ago Associate Director, Quality Assurance, Change Controls Irvine, CA $195,000.00-$260,000.00 9 months ago Director of Quality Engineering - Optical and Laser Systems Irvine, CA $154,000.00-$286,000.00 2 days ago Irvine, CA $141,000.00-$165,200.00 1 day ago Orange County, CA $158,000.00-$252,000.00 2 weeks ago Fountain Valley, CA $147,721.00-$203,101.00 3 days ago Fullerton, CA $135,000.00-$202,000.00 2 weeks ago Irvine, CA $110,000.00-$130,000.00 1 day ago Director of Operations - Pediatric Cardiovascular ServicesRegional Operations Director - Southern CA Santa Ana, CA $140,000.00-$200,000.00 1 day ago Placentia, CA $100,000.00-$139,000.00 4 months ago Irvine, CA $121,000.00-$177,000.00 4 days ago Huntington Beach, CA $120,000.00-$160,000.00 1 month ago Orange County, CA $180,000.00-$252,000.00 3 months ago Senior Director of Ambulatory Surgery Centers Santa Ana, CA $150,000.00-$190,000.00 6 days ago Orange County Director of Operations - Ambulance ServicesProduction Supervisor MUST BE AS9100/ISO and ITAR Trained Already Irvine, CA $166,600.00-$333,100.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr