Associate Director, QC Operations, US Site

General Description:

The Associate Director Quality Control (QC) will lead analytical strategy, method lifecycle management, and QC operations to support GMP testing and release of materials, intermediates, and finished products. Direct analytical team on the studies of the characterization of in-process, release, and stability samples in support of

manufacturing operations ensuring compliance with FDA/EU and international regulations. The position requires strong cross-functional collaboration with Regulatory Affairs, Process Development, Manufacturing, and Quality teams, as well as external vendor management. This position is in Hopewell, NJ reporting into the Director, QC Operations.

Essential Functions of the Job:

• Develop and oversee quality control (QC) procedures and programs for Good Manufacturing Practice (GMP) testing and product release.

• Lead and conduct laboratory investigations for Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results, including the authorship of technical documents such as Standard Operating Procedures (SOPs), Test Methods, and Validation Protocols/Reports.

• Manage assay development, qualification, and technical transfer processes for both internal and external vendors.

• Provide technical guidance and written support for Investigational New Drug (IND) submissions and other regulatory documentation.

• Coordinate and schedule analytical testing, ensuring thorough review and approval of test records, Certificate of Analysis (COA), and final reports.

• Train and supervise laboratory personnel, effectively managing direct reports to foster a high-performing team.

• Support troubleshooting during method transfers and validation studies, while authoring, reviewing, and approving experimental protocols, validation reports, test methods, and technical memos/reports.

• Guide the team in data analysis and trending to evaluate results and draw actionable conclusions to support decision-making.

• Ensure that all documentation is completed accurately, timely, and in compliance with regulatory standards.

• Provide decisive leadership and operational expertise to drive quality and efficiency within the QC department.

• Collaborate cross-functionally within the organization to shape product life-cycle timelines and support synthesis and formulation divisions effectively.

• Facilitate successful technology transfer between internal departments and external partners, including ARD, TPL, and Contract Manufacturing Organizations (CMOs).

• Establish and maintain a working environment that attracts and retains top talent, promotes ongoing staff development, and recognizes individuals with high potential in both technical and managerial roles.

Education/Experience Required:

• Bachelor's degree in Biology or related field and 8+ years of experience in analytical sciences and GMP/GLP environments; Master's degree preferred

• Minimum 5 years of managerial experience leading teams and projects

• Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc.

• Expertise in Chemistry or other closely related disciplines with 5+ years relevant work experience in pharmaceutical industry

• Strong understanding of GMP/GLP regulations

• Excellent project management and cross-functional collaboration skills

• Hands-on experience on analytical team building with strong problem-solving skills.

• Conversant with ICH guidelines, applicable law and regulations of major markets (China, US, EU, Japan, etc.), and other compendial requirements (USP, EP, ChP etc.)

• Experienced in CMC document preparation for IND and NDA filing.

• The candidate should be a very effective communicator, interacting with key stakeholders, regulators and other technical lines and matrix teams.

• Strong written and communication skills and an ability to work effectively with a diverse team of co-workers in a dynamic environment.

Travel: Up to 20%

Global Competencies :

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Collaborative SpiritFosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs Inclusively

• Bold IngenuityDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces Change

• Driving ExcellenceResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.