Sr. Director of Quality Operations & Technology

The Sr. Director of Quality Operations & Technology at Harrow is responsible for ensuring compliance with cGMP standards and FDA regulations related to ophthalmic products. This includes overseeing quality control activities for raw materials and finished products, managing external lab testing, and maintaining quality systems and documentation. The role is crucial in providing technical guidance on cGMP processes and improving laboratory testing methods.

Candidates for the Sr. Director of Quality Operations & Technology position at Harrow need a Bachelor's degree in Science or a related field, with a Master's degree preferred. A minimum of 15 years of experience in cGMP quality operations, particularly in the pharmaceutical industry, along with strong expertise in Analytical Chemistry and Microbiology, is essential. Familiarity with FDA regulations and the ability to review laboratory data accurately is also critical.

At Harrow, the Sr. Director of Quality Operations & Technology is expected to provide formal and informal performance feedback to team members, contributing to their professional growth. The company values employee development and offers resources to help team members advance their careers, including training and mentorship opportunities, ensuring a clear pathway for promotions and salary increases.

Harrow prides itself on having an entrepreneurial and collaborative company culture. The Sr. Director of Quality Operations & Technology will be part of a supportive environment where each team member is empowered to take ownership of their role. The company fosters open communication and encourages innovative thinking, making it a great place for professionals who want to make a meaningful impact in the field of ophthalmology.

The Sr. Director of Quality Operations & Technology at Harrow will supervise projects related to quality systems compliance, lab testing enhancements, and regulatory audits. They will also lead initiatives aimed at streamlining operational processes, integrating industry best practices, and ensuring that the quality assurance measures align with our commitment to delivering safe and effective ophthalmic products.

When answering this question, emphasize your extensive background in cGMP operations, detailing specific responsibilities you've held and your familiarity with FDA regulations. Highlight any successful initiatives you've led that aligned with compliance expectations and improved quality systems.

To tackle this question effectively, discuss your approach to staying updated on FDA regulations, and how you implement training and documentation procedures within your team. Share experiences where you established mechanisms to ensure ongoing compliance and addressed any non-compliance issues swiftly.

When discussing strategies, focus on your data-driven approach to identifying areas for improvement in quality control processes. Mention specific tools or methodologies you've employed to analyze quality trends and how you've engaged your team in continuous improvement initiatives.

Explain your strategy for maintaining productive relationships with external laboratories, highlighting your communication skills and experience with vendor qualifications. Discuss how you handle any challenges in collaboration and your commitment to ensuring quality standards are met.

Articulate your familiarity with audit processes, detailing any experiences where you led successful audit preparations, responded to findings, or implemented corrective actions. Emphasize the importance of audits in maintaining compliance and the proactive measures you've taken to prepare for them.

Use the STAR technique to describe a specific situation, the task at hand, your actions, and the outcome. Ensure to convey your problem-solving skills and how you learned from the experience, highlighting your ability to manage pressure effectively.

Discuss your leadership style, focusing on how you foster a collaborative environment that encourages input and recognizes contributions. Share your methods for providing feedback, setting clear expectations, and celebrating achievements to keep your team motivated.

Be prepared to mention specific metrics you consider crucial for assessing quality performance, such as OOS results, deviation trends, and compliance rates. Discuss how you utilize these metrics to drive improvements and report findings to upper management.

Explain your commitment to continuous learning and staying connected with industry trends. Mention attending professional conferences, reading relevant publications, and participating in networking opportunities to share insights with peers.

Convey your passion for ophthalmic pharmaceuticals and how Harrow aligns with your professional values and goals. Discuss the company's innovation, patient-centered approach, and how you believe you can contribute to its mission while enhancing quality operations.