Associate Director Quality
Natco Pharmaceuticals USA, Parsippany, NJ, United States
Benefits
401(k) 401(k) matching Competitive salary Dental insurance Health insurance Paid time off Vision insurance Overview
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. 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. Role
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. 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 3PLs 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). Travel: 10-15% of time. Qualifications
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. Diversity, Equity and Inclusion
At Natco Pharma USA, we believe that diversity is our strength. We celebrate different perspectives and embrace the unique qualities each individual brings to the table. Our commitment to building a team as diverse as the clients we serve fosters innovation, growth, and excellence. We’re dedicated to creating a workplace where everyone feels valued, respected, and empowered—free from harassment and discrimination. Join us in making a difference and contributing to a culture where authenticity thrives! Disclaimer / Equal Opportunity
Natco Pharma USA is a proud Equal Employment Opportunity employer and encourages applicants from all walks of life. All employment decisions are based on business needs, job requirements and individual qualifications without regard to race, religion, creed, color, sex, pregnancy, childbirth or related medical conditions, national origin, age, ancestry, veteran status, liability for military service or military status, disability, mental illness, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), unemployment status (with respect to job advertisements), affectional or sexual orientation, gender identity or expression, marital, domestic partnership, or civil union status, lawful activity outside the workplace during non-work hours, such as the use of tobacco products, or any other characteristics protected by law. Come join our team!
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401(k) 401(k) matching Competitive salary Dental insurance Health insurance Paid time off Vision insurance Overview
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. 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. Role
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. 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 3PLs 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). Travel: 10-15% of time. Qualifications
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. Diversity, Equity and Inclusion
At Natco Pharma USA, we believe that diversity is our strength. We celebrate different perspectives and embrace the unique qualities each individual brings to the table. Our commitment to building a team as diverse as the clients we serve fosters innovation, growth, and excellence. We’re dedicated to creating a workplace where everyone feels valued, respected, and empowered—free from harassment and discrimination. Join us in making a difference and contributing to a culture where authenticity thrives! Disclaimer / Equal Opportunity
Natco Pharma USA is a proud Equal Employment Opportunity employer and encourages applicants from all walks of life. All employment decisions are based on business needs, job requirements and individual qualifications without regard to race, religion, creed, color, sex, pregnancy, childbirth or related medical conditions, national origin, age, ancestry, veteran status, liability for military service or military status, disability, mental illness, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), unemployment status (with respect to job advertisements), affectional or sexual orientation, gender identity or expression, marital, domestic partnership, or civil union status, lawful activity outside the workplace during non-work hours, such as the use of tobacco products, or any other characteristics protected by law. Come join our team!
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