Harrow, Inc.

Sr. Director of Quality Operations

Ledgewood, NJ · Director

Sponsorship not specifiedDetected 35 days ago

ExpressBudgetingExcelSupply ChainPharmacy PracticeGMPFDA RegulatoryLeadershipCommunicationCritical ThinkingMicrosoft Office

About the role

Under the leadership of the Head of Quality, the Sr.
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 is a proactive leader passionate about resolving issues and improving processes to facilitate growth.

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
Partner with Manufacturing, MS&T, Supply Chain, and Compliance on quality-related decisions
Track and manage the quality release status of all in-process lots, ensuring compliance, optimal timing, and alignment with evolving release plan priorities
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.

Develop weekly/monthly/quarterly/annual goals and schedules to manage activities and the team

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

Before reading the job post, we encourage you to watch this video 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?
The incumbent will lead and meet the company's goals in product quality, staff development, and leadership.

This listing is sourced directly from Harrow, Inc.'s careers page and normalized into a canonical job model.