Sr. Director of Quality Operations Ledgewood, NJ

Job Summary

Under the leadership of the Head of Quality, the Sr. Director of Quality Operations will oversee the day-to-day operations of the Quality Assurance and Quality Control teams at Harrow’s Imprimis 503B outsourcing facility in Ledgewood, NJ. The role will ensure GMP compliance, product quality, and inspection readiness across the site or organization.

• Manage direct reports in the Quality Assurance and Quality Control departments.
• Lead day‑to‑day quality operations to ensure compliance with SOPs, cGMPs, FDA standards, USP/NF monographs, and state Boards of Pharmacy requirements.
• Establish quality strategy, priorities, and resource allocation to support manufacturing, testing, and supply objectives.
• Provide quality oversight of manufacturing, packaging, labeling, validation, and technology transfer activities.
• Partner with Manufacturing, MS&T, Supply Chain, and Compliance on quality‑related decisions.
• Sustain inspection readiness by maintaining and improving systems, processes, and procedures to meet regulatory requirements.
• Oversee managers responsible for internal QC laboratories and external contract testing laboratories.
• Lead state and federal health/drug authority inspections and collaborate with the Pharmacist‑in‑Charge on inquiries or deficiencies.
• Track agency commitments and ensure obligations are met.
• Oversee batch review and release processes, ensuring timely disposition of raw materials, components, and finished products.
• Manage quality release status of all in‑process lots for compliance and optimal timing.
• Lead investigations into out‑of‑specification results and deviations to determine root causes and identify CAPAs.
• Ensure data integrity of all documentation and data supporting compounded drug products distributed commercially.
• Continuously assess and improve the site’s quality systems by proactively resolving quality issues.
• Establish and monitor metrics for Quality’s Key Performance Indicators.
• Lead quarterly Management Reviews with the Leadership Team.
• Participate in Quality Governance Council meetings.
• Plan, budget, and administer expenditures for departmental activities.
• Develop weekly, monthly, quarterly, and annual goals and schedules to manage activities and the team.
• Manage a heavy workload and aggressive timelines, prioritizing under pressure.
• Serve as a coach and mentor to the quality unit staff, providing development and training opportunities.
• Perform duties following established company procedures and policies; perform other duties as assigned.

• Bachelor’s degree in Science, Engineering, or related field (Master’s preferred) or equivalent work experience.
• 10+ years of progressive leadership experience in a cGMP facility.
• People‑management experience with large groups (20+ employees).
• Strong technical understanding of manufacturing, laboratory, and quality systems.
• Proven leadership in regulatory inspections and complex quality decision‑making.
• Ability to balance compliance, operational efficiency, and business priorities.
• Experience with aseptic drug product bulk manufacturing (preferred).
• Ability to work autonomously with little direction.
• Strong written, verbal, and presentation communication skills.
• Proficiency in Microsoft Office Suite and database/documentation tools.
• Creative problem‑solving skills and sound business judgment.
• Ability to influence without direct authority.

On‑Site

Ability to travel up to 10% of the time.

Salary: 220k+

As set forth in Harrow, Inc.’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.