Quality Assurance Specialist I, CMO

Job description

*Before reading the job post, we encourage you to watch this [video](https://player.vimeo.com/video/746673398?h=813f818de3) 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®, BYOOVIZTM, and OPUVIZTM - **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 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** The **QA Specialist I** is responsible for administratively overseeing and supporting external manufacturing operations with our global CMO (Contract Manufacturing Organization) partners. As an individual contributor, this role provides QA oversight of CMO operations in compliance with business agreements, international regulatory requirements, and industry standards. Additionally, the position involves providing administrative support to the internal quality department, including managing tasks and projects for both department management and team members. **Core Responsibilities** - Act as QA Initiator and Investigator for Product Quality Complaints, ensuring timely initiation and investigation in accordance with compliance requirements. - Act as the key point of contact for internal teams and external manufacturing partners, fostering cross-functional collaboration while managing inquiries within the general QA mailbox. - Support the development and execution of CAPAs, change controls, validation documentation, and other GMP-related activities. - Deliver exceptional customer service related to Harrow Eye products, ensuring a commitment to achieving 100% customer satisfaction. - Collaborate closely with Harrow Eye’s External Manufacturing Team, Supply Chain, Pharmacovigilance, and Regulatory Affairs to maintain seamless communication with external manufacturing partners and internal stakeholders. - Effectively communicate issues, risks, and proposed solutions across the organization. - Assist in implementing policies, procedures, and training programs while providing support to the Quality Team on various tasks and initiatives. - Contribute to the preparation and execution of internal and external audits, as required. - Perform additional duties and responsibilities as assigned **Qualifications & Requirements** - Associate's degree or equivalent work and education in a related field; BA preferred. - 2+ years of experience in the pharmaceutical or related industry. Experience in quality assurance, quality control, or compliance is preferred but not required. - Strong organizational skills, including the ability to follow assignments through completion. - Basic knowledge of relevant regulations and guidance documents - Basic knowledge of CAPAs, Deviation investigations, Change Controls and Supplier Qualification Program. - Strong decision-making capability and ability to ask compelling questions and to think strategically and understand global impact of decision - Excellent oral 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 - Proficient in the use of standard Microsoft Office software products, including Outlook, Word, Excel, and PowerPoint required. - Knowledge of GxP systems is preferred but not required. - Exposure to AI tools such as ChatGPT, Claude, etc.