Associate Director Quality

Natco Pharmaceuticals USA•Parsippany-Troy Hills, NJ

11d

About The Position

Join Natco Pharma USA Team Natco Pharma USA is entering an exciting phase of growth as we expand our U.S. sales and distribution operations. Backed by the global strength of Natco Pharma Limited, we are committed to delivering high-quality, compliant pharmaceutical products to the U.S. market. What is Natco Pharma USA? Based in Northern New Jersey, we are a fast-growing, innovative specialty pharmaceutical company, distributing solutions for both retail and institutional needs from leading global manufacturers. We’re revolutionizing the U.S. pharmaceutical industry by making high-quality medicines more accessible and affordable. As a subsidiary of Natco Pharma Ltd., a global leader with a presence in over 50 countries, we are proud to bring top-tier pharmaceutical products to the American marketplace. Who are we looking for? We are seeking an experienced and hands-on Associate Director, Quality to lead and oversee the U.S. Quality function. This is a high-visibility role responsible for leading U.S. Quality and compliance activities, supporting external manufacturing partners, and upholding the highest standards of CGMP and product quality. In this lean, entrepreneurial environment, the Associate Director will serve as the primary Quality authority for U.S. operations, overseeing regulatory interactions, audit readiness, and product release activities.

Requirements

B.S. in a science discipline
Minimum of 10 years experience in the quality/compliance finished dosage form drug product area
Good communication skills
Knowledge of current and proposed CGMP regulations, guidances and initiatives, as applicable to Natco drug products.

Responsibilities

Support and coordinate Natco Pharma Limited and Natco Pharma USA ("NATCO") regulatory and pharmacovigilance initiatives.
Support qualification of Natco CMO and 3PL vendors. Perform scheduled CGMP audits of CMOs and 3PL vendors.
Supervise site audits of Natco by FDA, NJ regulatory agencies,. and customers. Prepare and submit CAPA responses to FDA until final approval and closure.
Monitor direct contacts with 3PL's including contract laboratories, LSL, SafetyCall. Maintain company and customer documents.
Approve and release Natco Pharma Limited and Natco Pharma USA, as applicable, CMO Master Batch Records, packaging and shipping authorizations, Change Controls, Deviations, OOS Investigations, Stability Program, COAs, COCs for finished product release for distribution.
Work with Safety call to document all product inquiries, complaints, and adverse events.
Review labeling.
Prepare, review and revise SOPs
Personnel Training