Job Description
Job Description
Job Summary -
Strides Pharma Inc. is seeking an experienced and detail-oriented Analytical Quality Assurance Manager to lead our AQA operations in Chestnut Ridge, NY. The AQA Manager 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.
Key Accountabilities & Responsibilities
AQA Management
- 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.
Workload Management
- 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.
SOPs
- 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.
Staff Development
- 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.
Education & Experience
- 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.
Knowledge
- 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)
Skills & Abilities
- Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organization's goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.
- Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
- Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates' activities; is available to staff; provides regular performance feedback; develops subordinates' skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.
- Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
- Demonstrated flexibility in carrying out varied assignments in a high quality work environment.
- Excellent written and oral communications skills with a strong emphasis on organizational capabilities.
- Excellent analytical thinking and problem-solving skills
- Strong attention to detail with a commitment to quality and compliance
- Effective leadership, team management, and interpersonal communication
- Ability to prioritize and manage multiple tasks in a fast-paced environment
- Proficient in technical writing and reviewing complex data and reports
Physical Requirements
- Ability to sit or stand for extended periods
- Occasionally lift up to 25 pounds
- Use of personal protective equipment (PPE) as required in laboratory or production areas
- Ability to work in office, laboratory, and manufacturing settings as needed
- The work environment is representative of a group laboratory environment.