Sr. Director of Quality Operations

Job Summary

Under the leadership of the Head of Quality, the Sr. Director of Quality Operations will oversee and lead the day-to-day operations of the Quality Assurance and Quality Control teams. They will oversee the quality of the company's 503B outsourcing facility in Ledgewood, NJ, to deliver business results focused on ensuring quality and compliance. Key aspects of the job include managing the Quality Unit to ensure consistent GMP compliance, product quality, and inspection readiness across the site or organization.

The successful candidate must demonstrate the ability to build and maintain teams, relationships, trust, and respect with employees, peers, and regulators. The successful candidate is a proactive leader passionate about resolving issues and improving processes to facilitate growth.

The incumbent will lead and meet the company's goals in product quality, staff development, and leadership. Will interact with all State and Federal governmental agencies (FDA, DEA, State boards of pharmacy, etc.). This position will ensure the established quality procedures are followed for the compounding of sterile and non-sterile drugs under section 503B of the US Food, Drug & Cosmetic Act.

It is critical to ensure a continuous and sustainable state of cGMP compliance.

Responsibilities will include leadership over adherence to the site's quality systems. This includes standard operating procedures, documentation control, change control, deviation & complaint handling, CAPA, quality control processes (analytical chemistry and microbiological testing, stability, and retention program), and material controls (including raw material, component and finished good batch release process).

• Manage direct reports in Quality Assurance and Quality Control departments at Harrow's Imprimis NJOF site in Ledgewood, NJ.
• Lead and direct the activities involved in day-to-day quality operations to ensure compounding quality controls and procedures are following Standard Operating Procedures (SOPs), US current Good Manufacturing Practices (cGMPs), US Food and Drug Administration (FDA) standards, and specifications, including USP/NF monographs, Boards of Pharmacy for each State.
• 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 a level of perpetual inspection readiness by maintaining and improving appropriate systems, processes, and procedures to meet regulatory requirements, guidelines, and industry standards
• Oversee the managers responsible for the activities of internal QC laboratories and external contract testing laboratories
• Lead both state and federal health/drug authority inspections
• Collaborate with Pharmacist-in-Charge to respond to state and federal health/drug authorities about inquiries or deficiencies identified during inspections
• Track the status of agency commitments and ensure such obligations are met
• Oversee the batch review and release process, ensuring thorough review and timely disposition of raw materials, components, and finished drug products
• Track and manage the quality release status of all in-process lots, ensuring compliance, optimal timing, and alignment with evolving release plan priorities
• Provide leadership over investigations into out-of-specification analytical results and deviations during compounding activities to determine root cause and identify CAPAs to prevent recurrences
• Ensure data integrity of all documentation and data supporting compounded drug products that are commercially distributed
• Engage in activities to continuously assess and improve the site's quality systems by identifying and proactively resolving quality issues as needed
• Establish and monitor metrics for the measurement of Quality's Key Performance Indicators to ensure the site's quality systems and distributed products consistently and efficiently meet the highest quality standards for patients
• Lead quarterly Management…