QC Manager

Recruitment Consultant at Barrington James | Recruiting Technical Operations Professionals for Biotechs - USA I am currently partnered with an exciting and outstanding client of ours who is looking to grow their QC team! The QC Manager will be leading a team of 5-6 members of the vertical further towards ANDA/ NDA submissions this year. They plan to grow the company from 30 to 250 within the next three years as well as open up new facilities across the Tri State area. This position will allow for growth and leadership! You will be reporting into the Senior Director of Quality. Responsibilities: Lead, mentor, and develop a team of analysts to ensure data integrity, compliance, and strong performance. Oversee daily scheduling of testing activities to support manufacturing, API production, and product release timelines. Establish, document, and maintain QC standards, procedures, and objectives aligned with cGMP and global regulatory expectations (FDA, EMA, ICH). Review and interpret analytical data (HPLC, GC, UV, FTIR) in accordance with USP, EP, BP, JP, IP, and internal specifications. Author and approve SOPs, specifications, analytical methods, validation protocols, and reports. Perform and supervise analytical testing of APIs, excipients, intermediates, stability samples, and finished products (including generics). Develop and validate new analytical methods to support product development and regulatory submissions (ANDA/NDA). Conduct laboratory investigations, root cause analysis, and implement CAPAs, Change Controls, and continuous improvement initiatives. Ensure adherence to stability programs, environmental monitoring, and quality metrics reporting. Manage outsourcing of testing to contract laboratories and ensure third-party compliance. Maintain laboratory instrumentation (HPLC, GC, UV, FTIR, dissolution systems) including troubleshooting and preventative maintenance. Promote lab safety, oversee chemical inventory, and ensure compliance with OSHA and environmental regulations. Support FDA and international regulatory inspections, internal audits, and client audits. Act as technical SME during regulatory submissions, data reviews, and inspections. Perform QC testing as needed to support workload surges and critical release deadlines. Requirements: Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field with minimum 5 years’ laboratory management experience or Master’s degree in Chemistry, Pharmaceutical Sciences, or related field with minimum 3 years’ laboratory management experience Experience in an FDA-regulated QC laboratory with focus on APIs, generics, and commercial pharmaceutical products. Strong technical expertise in analytical chemistry, including method development and validation. Proficiency with Empower 3, HPLC, GC, and spectroscopy systems. In-depth knowledge of USP monograph testing, CFR & ICH guidelines, cGMP, GLP, and GDP principles. Seniority level: Mid-Senior level Employment type: Full-time Job function: Management Industries: Pharmaceutical Manufacturing Barrington James is an equal opportunities employer and welcomes applications from all suitably qualified persons.

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