QA Compliance Auditor

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us.

Who is Harrow?

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 (1) innovation, (2) patient access to affordable medicines, and (3) 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^TM, and OPUVIZ^TM
• 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^TM
• 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 cGMP compliance audits of the company’s suppliers/vendors, contract organizations, and internal Harrow Health sites. As a QA Compliance Auditor, you will have the opportunity in a high-visibility role to ensure that Harrow’s suppliers/vendors, contractor organizations, and the company’s sites continue to enable our mission by providing high-quality, safe, and effective products. This role supports the various businesses within Harrow Health, including our 503A compounding, 503B compounding, and approved drug product businesses.  

Core Responsibilities 

• Conduct onsite, remote, and/or paper-based Qualification audits of the company’s raw material suppliers/vendors and contract organizations 
• Prepare and issue audit reports and/or non-compliances to respective suppliers; collaborate with them for prompt response and resolution of identified issues 
• Propose recommended qualification of suppliers/vendors, endorse and contract organizations 
• Help maintain the Supplier Qualification program and associated documentation 
• Oversee and negotiate Quality Agreements between suppliers and Harrow 
• Collect, trend, and report supplier quality metrics 
• Review change control for 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 for prompt implementation of corrective and preventive actions (CAPAs) of identified issues 
• Other duties as assigned by leadership 

Qualifications & Requirements 

• Expert knowledge of US FDA pharmaceutical and/or drug compounding cGMP regulations 
• Bachelor’s degree in life sciences, engineering or equivalent work and education in a related field 
• 3 years of experience in pharmaceutical supplier quality preferred 
• Experience conducting cGMP audits; auditor certification preferred 
• Willingness to travel (up to 50% of the time) 
• Experience working autonomously with proven ability to meet deadlines 
• Experience with full life cycle project management (initiation, planning, design, and execution) 
• Strong organizational skills with the proven ability to prioritize, multitask, and be detail-oriented 
• Strong communication skills, both verbal and written 
• Strong collaboration and teamwork skills: good communications, 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  

• On-site 

Travel 

• Up to 50% to audit suppliers.