Supervisor, Analytical Quality Assurance (AQA)

Strides Pharma Inc • Chestnut Ridge, NY

76d

About The Position

Strides Pharma Inc. is seeking an experienced and detail-oriented Analytical Quality Assurance Supervisor to lead our AQA operations in Chestnut Ridge, NY. The AQA Supervisor will be responsible for overseeing the review and approval of analytical data, ensuring compliance with cGMP regulations, and supporting product release and regulatory submissions. This role will collaborate cross-functionally with the Quality Control, Regulatory Affairs, and Manufacturing departments to maintain high standards of product quality and integrity. Supervisory responsibilities within a single site.

Requirements

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or related field (Master’s or Ph.D. preferred)
• Minimum of 10 years of experience in pharmaceutical analytical quality assurance or quality control
• Proven leadership or supervisory experience in a GMP-regulated environment
• Experience with analytical instrumentation (HPLC, GC, UV, IR, etc.) and associated data review
• Demonstrated management and leadership experience with strong interpersonal and influencing skills.

Nice To Haves

• Strong understanding of FDA regulations, cGMP, ICH guidelines, USP/EP compendia
• Knowledge of pharmaceutical manufacturing processes and laboratory practices
• Familiarity with regulatory submission requirements (ANDA, NDA, etc.)
• Proficiency with laboratory software and documentation systems (e.g., Empower, LIMS, TrackWise)

Responsibilities

• Manage all Analytical and Quality Control (QC) activities to ensure compliance with cGMP, FDA, EMA, and ICH guidelines.
• Lead a team of data reviewers, ensuring accurate, complete, and timely review of raw data, analytical results, and laboratory documentation.
• Supervise the Stability Program and Coordinator, including protocol approval, sample pull scheduling, data review, and reporting.
• Ensure analytical data integrity through implementation and oversight of robust review processes and audit trails.
• Collaborate with QC, QA, and R&D departments to support method validations, transfers, and investigations.
• Review and approve analytical documentation such as CoAs, method validation/verification protocols and reports, and stability summaries.
• Lead or support investigations into out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents.
• Support regulatory inspections and internal/external audits, providing documentation and subject matter expertise.
• Drive continuous improvement initiatives in QA/QC processes and systems to ensure operational excellence and regulatory readiness.
• Mentor, coach, and develop the AQA team to build a high-performing quality organization.
• Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.
• Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.
• Review/Approve SOP’s, procedures and monographs for the QC Group as needed.
• Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.
• Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.
• Evaluate potential candidates for QA; performance evaluation of direct reports.
• Coordinate data review for analytical tests, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree