Job Details

Join to apply for the 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.

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 level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  IT 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 Services

Regional 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 Services

Production 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