What are the responsibilities and job description for the Operations Compliance Specialist position at Harrow?
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 Operations Compliance Specialist is responsible for ensuring that compliance in production areas is adhered to at all times. This includes but is not limited to, a review of SOPs, identifying GAPS in SOPs and Processes with appropriate CAPA, change control, and risk mitigation provisions to ensure 100% compliance. To succeed in this position, a person must have a thorough understanding of the FDA GMP requirements, Pharmaceutical technical processes, a mindset of high standards for Quality, and the ability to express complex technical problems in simple, straightforward language, both verbally and in writing.
Core Responsibilities
- Provides leadership to production staff for compliance-related matters.
- Conducts thorough GAPA analysis for production quality systems and processes, identifying opportunities for risks, including prevention, monitoring, and resolution, and placing appropriate measures to mitigate risks.
- Coaches and Mentors, compliance investigators on conducting root cause analysis and placing appropriate CAPA in place to prevent recurrences.
- Acts as a Subject Matter Expert on behalf of production for any continuous improvement, facility expansion, and process improvement projects.
- Acts as a Subject Matter Expert during regulatory audits.
- Monitors trends and conducts trend analysis for deviations, change controls and CAPAs to understand trends and provides findings to production management with alternate solutions to prevent recurrences.
- Providing training and awareness to educate employees in in-scope business areas on emerging risks, issues, and policy requirements.
- Routine interaction with the site management, including compilation of spreadsheets to communicate investigational status and CAPA discussions.
- Work on the production floor for data gathering and observing processes for enhanced compliance.
- Perform other duties as assigned.
Qualifications & Requirements
- Associate or bachelor’s degree in a scientific field or 3-5 years of extensive experience in the pharmaceutical industry, preferably in Product Manufacturing with demonstrated experience working in Quality functional areas.
- Excellent problem-solving skills.
- Working knowledge of root cause analysis tools
- Excellent technical writing skills
- Expert knowledge of manufacturing operations
- Working knowledge of Microsoft Word, Excel, and PowerPoint is necessary
Position Type
- On-Site
Travel
- None