Quality Manager

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 one of the leading U.S. ophthalmic-focused pharmaceuticals companies.  Aside from being a for-profit company, from a cultural perspective, all members of the Harrow Family are proud of our commitment to (1) innovation, (2) patient access to, and affordability of, our medicines, and (3) that we have never turned down an ophthalmologist doing mission work around the world – to provide free-medicines – to support their work to give to the gift of sight to those most in need.    

Harrow owns numerous branded pharmaceutical products, including Iopidine, Maxitrol, Moxeza, Triecense, Vigamox, Maxidex, Nevanac, Ilevro, and Iheezo. In addition, Harrow owns and operates ImprimisRx, the nation’s leading ophthalmology-focused compounded pharmaceuticals, including its FDA-registered and FDA-inspected 503B outsourcing facility and a 50-state mail order pharmacy – both of which are in Ledgewood, New Jersey.

Harrow also holds non-controlling equity positions in Eton Pharmaceuticals, Surface Ophthalmics, and Melt Pharmaceuticals, all of which started as Harrow Health subsidiaries, and owns royalty rights in four clinical-stage drug candidates being developed by Surface Ophthalmics and Melt Pharmaceuticals. 

At Harrow, we foster our individual and collective entrepreneurial and creative spirits. We focus on pursuing opportunities for drug candidates in underserved markets. We are data-driven and use our access to real-world clinical experience to lower the investment risks of our work. We concentrate on the commercial appeal of high-value assets, and our objective is to seek to make paradigm-shifting medicines available to patients as soon as possible. Our approach to finding high-value opportunities and balancing risk with real-world experience can deliver exceptional value for all our stakeholders

Job Summary

As the QA Manager for Sterile Ophthalmic Products, you will play a pivotal role in ensuring the quality and compliance of our contract manufacturing processes and products. Your primary responsibility will be to lead and manage the Quality Assurance team, implementing and maintaining quality systems that meet regulatory requirements for sterile pharmaceuticals.

In addition to their primary responsibilities, the QA supervisor also offers essential administrative assistance to the internal quality department. This multifaceted position involves handling administrative tasks and projects for both the management and other members of the quality department, contributing to the overall efficiency and effectiveness of the team's operations.

Essential Responsibilities

Team Leadership:

• Supervise and lead the QA team, providing guidance, training, and support to ensure a high level of performance and compliance.
• Foster a culture of continuous improvement, accountability, and proactive problem-solving within the QA team.

Quality Systems Management:

• Develop, implement, and maintain robust quality systems in collaboration with our Contract Manufacturing Organization (CMO) partners, ensuring compliance with regulatory requirements, including but not limited to cGMP, FDA, and other relevant guidelines.
• Conduct joint internal audits with CMOs and oversee external audits to assess compliance with quality standards.

Regulatory Compliance:

• Work closely with our Contract Manufacturing Organization (CMO) partners to stay abreast of changes in regulatory requirements related to sterile ophthalmic products, ensuring joint compliance efforts.
• Interface with regulatory agencies during inspections and provide necessary documentation and support

Record Review:

• Collaborate with CMOs to oversee the joint review and approval of batch records, protocols and APQR, ensuring accuracy, completeness, and compliance with established procedures.

CAPA Management:

• Manage and provide Approval of deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPA) as needed.

Change Control: