Sr. Director of Quality Operations & Technology

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 North American ophthalmic-focused pharmaceutical company. 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 Posterior Portfolio including IHEEZO® and TRIESENCE®
• A broad Dry Eye Disease product line, led by VEVYE® and bolstered by well-known adjacent ocular surface disease products such as FLAREX® and TOBRADEX® ST
• A Specialty Anterior Segment product line, which includes various high-need and utility products such as ILEVRO®, NEVANAC®, and VERKAZIA®

Job Summary

 

The Senior Director of Quality Operations and Technology will ensure the company goals are met for product quality, cGMP analytical and microbiological testing as they relate to finished goods, excipients, components and Environmental Monitoring. This position will ensure that Operations follow the cGMP standards required under Sections 503B of the US Food, Drug & Cosmetic Act. The Senior Director of Quality Operations and Technology will provide guidance for improving cGMP processes, laboratory testing processes and Quality Assurance processes for greater compliance with increasingly stringent regulatory expectations. The successful candidate must have demonstrated technical expertise in Analytical Chemistry, Microbiology, FDA cGMP regulations for 503B, USP requirements, State Boards of Pharmacy regulations and have experience in FDA and State Boards of Pharmacy regulatory inspections. The candidate must build and maintain relationships, trust, and respect with subordinates, peers, and leadership.

 

Position Responsibilities

• Ensure compliance with US Food, Drug & Cosmetic Act, Section 503B, and all cGMP elements related to facilities, utilities, warehousing, production, testing, documentation, training, reports and records.
• Responsible for all QC activities related to, incoming raw materials, in-process raw materials, finished products, process validation, environmental monitoring, root cause analysis, and technical guidance.
• Maintaining quality systems, including but not limited to change control, CAPA, deviations/investigations, product complaints, vendor qualification. Review and approve complex 503B quality systems documentation in multiple technical areas, including SOPs, batch records, protocols, forms, checklists, etc.
• Management external testing laboratory and for out-of-specification results ensuring that all investigations proceed in a logical, orderly and timely manner and that appropriate corrective and preventive actions are identified, when necessary, review and approve investigation reports.

• Oversee operations of the in-house microbiology lab and analytical lab in Nashville.
• Manage implementation and maintenance of Quality Systems following cGMP, including but not limited to, Laboratory Procedures (SOPs), Deviations, Personnel Training, and Policies. Interpret SOPs/Methods/Specifications and provide clarity as needed.
• Support the site Stability program for testing, data analysis, validation, and commercial products. The position will partner with QA to ensure the stability program remains in a state of sustainable compliance.
• Oversee in-house EM program, Sterile Water for Injection still monitoring, Gown Qualification and Media Fill pro