Summary:
We are seeking a Director of Quality Compliance to join our team at SpyGlass Pharma. This role will be responsible for establishing, maintaining, and overseeing the global Quality Management System (QMS) compliance framework for pharmaceutical & drug-device combination products. This role drives internal and external lifecycle compliance monitoring, manages the corporate audit program and leads risk-based auditing, and leads inspection readiness across internal sites and external partners (CMOs, CROs, and device component suppliers).
This role leads and develops a team that ensures consistent, high-quality audit execution across SpyGlass Pharma's global manufacturing and supply network, including internal manufacturing facilities, external contract manufacturers, laboratories, suppliers, distributors, and other third-party partners. The role partners closely with cross-functional stakeholders to ensure compliance risks and systemic issues identified through audits are appropriately documented, escalated, trended, and resolved, while driving consistency, continuous improvement, and sustained quality oversight across SpyGlass Pharma's global supply chain. This role will also lead to inspection readiness activities such as pre-approval inspection (PAI) and regulatory surveillance audits.
Essential Duties & 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.
- Lead and oversee execution of quality system activities to ensure compliance with internal procedures, applicable regulatory requirements and standards for SpyGlass' product life cycle including supplier's lifecycle management program
- Manage and lead the quality compliance group to ensure effective implementation and compliance monitoring and maintenance of SpyGlass Quality System
- Provide strategic and operational leadership for core Quality System activities and processes including continuous improvement initiatives, trending and monitoring of quality system performance/risks/mitigations, management reviews and product annual reviews
- Oversee Management Reviews
- Ensure all GxP computerized systems are validated in compliance with quality policies, standards and procedures and are maintained in validated state throughout the lifecycle
- Collaborate with cross-functional stakeholders to identify compliance gaps, emerging risks, and opportunities for proactive compliance or continuous improvement initiatives.
- Collaborate with QA, RA, Medical Affairs, Manufacturing and R&D to ensure product quality complaints are assessed for potential safety, regulatory reporting, recall, field action and manufacturing investigations
- Design and execute the annual global internal and external audit programs.
- Lead risk-based audits of internal manufacturing sites and external partners, including contract manufacturers, laboratories, suppliers, distributors, and other third parties.
- Oversee lifecycle compliance and performance monitoring of Contract Manufacturing Organizations (CMOs) and critical hardware/component vendors.
- Promote awareness of current regulatory expectations across clinical and commercial manufacturing platforms and incorporate identified trends into audit program strategy and focus
- Draft, negotiate, and enforce Quality Agreements with external partners
- Identify, assess, and appropriately escalate compliance risks and systemic issues to management to support timely evaluation and resolution
Qualifications Required For Position:
- 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)
Certificates/Licenses Required For Role:
- Qualified Auditor Certification a strong plus
Why SpyGlass Pharma?
- We are offering a range of $200,000 - $225,000 based on experience and qualifications, along with an Annual Bonus opportunity.
- Share in our success with stock options, giving you a stake in the company's future.
- Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.
- Generous paid time off, including holidays, vacation days, and personal leave.
