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 U.S. ophthalmic-focused pharmaceutical company. The Company was founded and continues operating based on the highest corporate values. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to and affordability of our 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.
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.
Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:
- IHEEZO:
- 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;
- TRIESENCE®:
- A Specialty Anterior Segment product line, which includes various high-need and utility products such as ILEVRO®, NEVANAC®, and VERKAZIA®;
- ImprimisRx is the nation’s leading ophthalmology-focused compound pharmacy, including an FDA-registered and FDA-inspected 503B outsourcing facility and a 50-state mail-order pharmacy. The division of Harrow serves as an innovation hub and plays a vital role in Harrow’s mission to help patients maintain their gift of sight.
Job Summary
As the External Manager Quality Assurance 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 Manager 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.
Decision-Making Authority:
- Approve or reject deviations, CAPAs, change controls, and quality agreements.
- Provide the final decision on batch disposition (release or reject).
- Approve master batch records and raw material specifications.
- Define GMP-related strategies and positions in collaboration with key stakeholders.
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:
- Work collaboratively with CMOs to manage the change control process for sterile ophthalmic products, assessing the impact on quality systems and ensuring joint documentation and approvals.
Vendor Management:
- Collaborate with the procurement team to assess and manage the quality of materials and services provided by external vendors and contract manufacturing organizations (CMOs).
Other duties:
- Engage in various Quality and compliance projects as delegated by the management.
- Fulfill other duties as assigned.
Qualifications
- A minimum of BS/BA in a scientific discipline.
- 6+ years related industry experience with a minimum of 2 years’ management experience in quality assurance, quality control and compli
- Strong organizational skills, including ability to follow assignments through to completion.
- Knowledge of relevant regulations and guidance documents
- Strong decision-making capability and ability to ask compelling questions and to think strategically and understand the global impact of decision.
- Excellent verbal and written communication skills
- Detail-oriented with skills in problem solving and solid decision-making abilities.
- Experience with working autonomously with proven ability to meet deadlines.
- Experience with full life cycle project management (initiation, planning and design, and executing)
- Experience working with Contract Manufacturing Organizations (CMOs) preferred.
- Proficient in the use of standard Microsoft Office software products, including Outlook, Word, and Excel required.
What We Do
Harrow (NASDAQ: HROW) is a growing leader in the ophthalmic healthcare market.
Our mission as a growing leader in the ophthalmic healthcare market is driven by two core values: (1) unyielding dedication to innovation and (2) a mission of providing affordable and accessible medications. We pride ourselves on closely listening to the needs of providers and their patients, so we can do everything in our power to address them with high-quality products and services.
Our worthwhile mission is producing amazing financial results, and because we’ve produced a 72% compound annual growth rate for our first eight years in business, we are one of the fastest-growing ophthalmic pharmaceutical companies in the United States.
