QA Compliance Auditor
Ledgewood NJ
Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow's values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to innovation, patient access to affordable medicines, and our track record of having never turned down an ophthalmologist doing mission work around the world providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you're the right person to help contribute as we build a truly exceptional company, one we are all so proud of!
Harrow's ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:
- An expanding Retina Portfolio including IHEEZO, TRIESENCE, BYOOVIZ, and OPUVIZ
- A broad Dry Eye Disease product line, led by VEVYE and bolstered by well-known adjacent ocular surface disease products such as FLAREX and FRESHKOTE
- A peri-operative Surgical product line, led by TRIESENCE and BYQLOVI
- A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO, NATACYN, and VERKAZIA
- A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01
Job Summary
The QA Compliance Auditor is responsible for overseeing and continuously improving the site's Supplier Quality Management program. This role owns the Approved Supplier List (ASL), supplier qualification and requalification activities, supplier-related quality systems, including Supplier Corrective Action Requests (SCARs), and internal audit activities. As the QA Compliance Auditor, you will serve as the primary Quality representative for supplier performance and compliance, ensuring alignment with applicable regulatory requirements and internal quality standards. This role provides strategic oversight of audit outcomes and may perform or support on-site audits as needed. The role supports the various businesses within Harrow Health, including our 503B compounding business and our approved drug product business.
Core Responsibilities
- Help maintain the Supplier Qualification program and associated documentation
- Lead and maintain the site's Approved Supplier List (ASL), ensuring suppliers are appropriately qualified, categorized, and risk-ranked
- Own the supplier qualification and onboarding process, including risk assessments and required documentation review
- Manage periodic supplier requalification, ensuring compliance with internal procedures and regulatory expectations
- Initiate, manage, and close Supplier Corrective Action Requests (SCARs)
- Drive root cause investigations and ensure timely and effective resolution of supplier-related quality issues
- Monitor and trend supplier performance metrics (e.g., deviations, complaints, SCAR effectiveness)
- Partner cross-functionally to address supplier-related risks impacting product quality or supply continuity
- Manage/deliver audit reports and/or non-compliances to respective suppliers' vendors; collaborate with them for prompt response and resolution of identified issues
- Propose recommended qualification of suppliers/vendors endorse and contract organizations
- Oversee and negotiate Quality Agreements between suppliers and Harrow
- Collect, trend, and report supplier quality metrics
- Review change control room supplier/vendor qualification status
- Conduct onsite internal cGMP audits of Harrow's sites and support regulatory inspections
- Prepare and issue audit reports to communicate risks / non-compliances to respective department heads and Quality Leadership; collaborate with the site to ensure prompt implementation of corrective and preventive actions (CAPAs) of identified issues
- Other duties as assigned by leadership
Qualifications & Requirements
- Expert knowledge of US FDA (21 CFR) pharmaceutical and/or drug compounding cGMP regulations
- Bachelor's degree in a scientific or technical discipline
- 5-8+ years of experience in Quality Assurance within the pharmaceutical, biotech, or related regulated industry
- Demonstrated experience in supplier quality management, including qualification, ASL management, and SCARs
- Experience conducting cGMP audits; auditor certification preferred
- Willingness to travel (up to 15% of the time)
- Experience with working autonomously with proven ability to meet deadlines
- Experience with full life cycle project management (initiation, planning and design, and executing)
- Strong organizational skills with the proven ability to prioritize, multi-task and be detail oriented
- Strong communication skills, both verbal and written
- Strong collaboration and teamwork skills: good communication, facilitation, and coordination
- Ability to communicate effectively with individuals at various levels of the organization, various partners, and various departments or disciplines
- Strong written, verbal and presentation communication skills.
- Ability to think creatively in confronting issues and pursuing novel approaches to old problems.
- Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.
- Ability to manage multiple projects simultaneously, adjusting priorities as needed and meeting deadlines.
Position Type
Travel
- Potential for occasional travel to supplier sites, if necessary