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. Harrows 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 youre the right person to help contribute as we build a truly exceptional company, one we are all so proud of!
Harrows ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:
- An expandingRetina Portfolio including IHEEZO, TRIESENCE, BYOOVIZTM, and OPUVIZTM
- Abroad 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 BYQLOVITM
- 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
Under the Head of Quality's leadership, the PIC will provide leadership and support for the development and implementation of strategic quality and operational initiatives for the company's 503B outsourcing facility in Ledgewood, NJ, to deliver business results focused on quality and compliance. The PIC position requires a high level of knowledge across aseptic manufacturing, good manufacturing practices, quality, and regulatory compliance. The PIC must maintain pharmacist licensure in good stnding in specific states and is expected to provide clinical expertise on matters with the potential to impact product safety.
Core Responsibilities
NOTE: Core responsibilities will be finalized based on the incumbents expertise and the organizational needs of the company.
- QA Oversight of Production
- Complete training and remain qualified to perform all operations that the PIC oversees, including sterile garbing and gowning, compounding, aseptic filling, visual inspection, and labeling
- Perform production review of executed batch production records
- Participate in investigations related to potential or actual deviations, out-of-specification results, or other incidents related to the drug product
- Respond to internal audit findings
- PIC Licensure Responsibility
- Serve as a designated Pharmacist-in-Charge, assuming state pharmacist licensure responsibility.
- Ensure operations conducted under PIC responsibility meet all applicable legal, regulatory, and professional standards.
- Support policies, procedures, and operational practices required to maintain facility and pharmacist licensure and good standing.
- Clinical & Regulatory Compliance
- Oversight and management of Adverse Drug Event (ADE) reporting, investigation, trending, and corrective action processes.
- Ensure ADEs are handled and reported in alignment with federal, state, accrediting body, and organizational requirements.
- Assist with compliance & regulatory evaluation of and (as requested) provide clinical input on new product development opportunities.
- Regulatory Communication & Support
- Assist with regulatory communications, including drafting responses, gathering documentation, and participating in inspections or audits as assigned.
- Support regulatory inquiries, deficiency responses, and follow-up actions within the defined scope of responsibility.
- Serve as a clinical liaison during regulatory interactions when delegated.
Qualifications & Requirements
- Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy (BSPharm).
- Active, unrestricted pharmacist license in good standing (state(s) as required by the organization as listed below and ability to obtain licensure in additional states as requested:
- Minimum 57 years of pharmacy experience, including GMP and regulatory or compliance-related responsibilities.
- Demonstrated knowledge of sterile compounding, ADE & complaint management, and controlled substance regulations.
- Experience participating in regulatory inspections, audits, or compliance investigations.
- Strong written and verbal communication skills, including regulatory correspondence.
- Familiarity with DEA, State Board of Pharmacy, accrediting organizations, and patient safety standards.
- Demonstrates sound regulatory and clinical judgment when interpreting pharmacy laws, regulations, and accreditation standards within assigned scope.
- Appropriately balances patient safety, operational realities, and compliance obligations when making recommendations or decisions.
- Understands when to escalate issues and when to act independently under delegated authority.
Pharmacist License Required
- Alaska, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Nebraska, Nevada, Ohio, Oklahoma, Oregon, Texas, Virginia, and West Virginia
Pharmacist License Preferred
- Alabama, Arkansas, Mississippi, Tennessee, California, and Illinois
Position Type
Travel
- Up to 20% as an Imprimis NJOF representative
