Strides · 3 months ago
Supervisor, Analytical Quality Assurance (AQA)
Chestnut Ridge, NY, US
Full-time
Onsite
Senior Level, Lead/Staff
$80K/yr - $110K/yr
10+ years expStrides 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.
BiotechnologyHealth CareLife ScienceManufacturingPharmaceutical
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
Qualification
Required
Bachelor's degree in Chemistry, Pharmaceutical Sciences, or related field
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
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)
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
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
Preferred
Master's or Ph.D. in Chemistry, Pharmaceutical Sciences, or related field
Company
Strides
Strides Pharma Science is a global pharma company headquartered in Bengaluru and a footprint across 100 countries.
1001-5000 employees
H1B Sponsorship
Strides has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (10)
2023 (1)
2022 (3)
Funding
Current Stage
Public CompanyTotal Funding
$32.5MKey Investors
InvAscent
2019-07-05Post Ipo Equity
2018-10-31Post Ipo Equity· $20M
2012-08-09Post Ipo Equity· $12.5M
Leadership Team
Nandini Matiyani
EVP & Global HR Head
Recent News
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2025-12-09
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