Director, Global Quality Compliance & Inspection Readiness

Socket.dev; Irvine (CA); On-site; USD 200,000 - 225,000; Full time

Benefits offered by this job

Annual Bonus

Stock options

Health, dental, and vision insurance

Generous paid time off

Job summary

SpyGlass Pharma in Irvine, CA seeks a Director of Quality Compliance to establish and oversee the global QMS compliance framework for pharmaceutical & drug-device combination products. You will drive audit programs, lead risk-based audits, and ensure inspection readiness across internal sites and external partners, including CMOs, CROs, and suppliers.

You will lead a team delivering consistent, high-quality audit execution across SpyGlass Pharma’s global network, working with cross-functional

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Pharmacy, or Biomedical Engineering. Advanced degree preferred.
• 12+ years in a regulated GxP pharmaceutical or biotechnology setting (at least 3+ years focused on drug‑device combination products is a plus)
• Strong knowledge of U.S regulatory requirements (GMP/GXPs) & direct operational knowledge of 21 CFR Part 4, 210/211, 820, ISO 13485, and ISO 14971
• Excellent knowledge of Quality Management Systems, Quality Compliance programs, Business processes and industry best practices for clinical and commercial pharmaceutical products
• Proven track record hosting health authority audits and leading global supplier audit teams (Sterile ophthalmic and combination products experience preferred). Certified Quality Auditor (ASQ CQA/CQE) is a strong plus
• Demonstrated leadership experience in managing quality teams and oversight of pharmaceutical quality system management
• Demonstrate direct experience leading FDA inspections (ie. PAI) for pharmaceutical products
• Excellent negotiation skills, and the ability to communicate effectively with all levels of the organization and external stakeholders
• Excellent knowledge of Quality Management Systems/Quality Compliance programs/processes and industry best practices for development and commercial pharmaceutical products
• Technical expertise in Microsoft Office (Outlook, Word, Excel, PowerPoint)
• Willingness to travel 10-15% (both domestic and international)
• Qualified Auditor Certification a strong plus

Responsibilities

• Serve as the primary Quality lead for regulatory authority inspections (e.g., FDA) partnering closely with QA to address inspection product related requests, questions and issues.
• Lead inspection readiness simulations internally and at partner facilities to secure seamless product approvals.
• Manage consultants supporting PAI readiness assessments, preparations, and mock inspection activities
• Facilitate remediations/risk mitigations with internal and external functional teams to ensure successful PAI outcome
• Provide leadership, coaching and training to audit team and SMEs on (PAI) inspection preparation and readiness
• Maintain QMS compliance with both drug regulations (21 CFR Part 210/211) and medical device requirements (21 CFR Part 820 / ISO 13485), specifically addressing 21 CFR Part 4 for combination products.

Skills

Regulatory compliance leadership

Quality management systems

Auditing leadership

Cross-functional collaboration

Stakeholder communication

Education

Bachelor's degree in Life Sciences/Chemistry/Pharmacy/Biomedical Engineering

Advanced degree preferred

Tools

Microsoft Office

Job description

SpyGlass Pharma in Irvine, CA seeks a Director of Quality Compliance to establish and oversee the global QMS compliance framework for pharmaceutical & drug-device combination products. You will drive audit programs, lead risk-based audits, and ensure inspection readiness across internal sites and external partners, including CMOs, CROs, and suppliers.

You will lead a team delivering consistent, high-quality audit execution across SpyGlass Pharma’s global network, working with cross-functional