Development quality assurance

Meril · Ahmedabad, India

Senior Manager / Manager – Development Quality Assurance (DQA)
Location: Vapi, Gujarat
Experience: 10 –15 Years

Job Summary
We are seeking an experienced Senior Manager / Manager – Development Quality Assurance (DQA) to establish, maintain, and continuously improve the Development Quality Assurance (DQA) system supporting Research & Development activities. The ideal candidate should have strong expertise in Biologics or Cell & Gene Therapy (CGT) , with extensive experience in quality systems, regulatory compliance, data integrity, and quality oversight across the product development lifecycle.
Key Responsibilities:
Prepare, review, revise, and periodically update Quality Assurance SOPs, templates, formats, and other controlled quality documents supporting R& D activities.
Establish, implement, maintain, and continuously improve the Development Quality Assurance (DQA) system.
Develop and implement quality procedures supporting process development, analytical development, formulation development, technology transfer, process characterization, and stability studies.
Review R& D documentation, including SOPs, Work Instructions (WIs), Equipment Operating Procedures (EOPs), specifications, protocols, reports, technical documents, process and analytical development records, method qualification, method transfer, and technology transfer documentation.
Provide independent quality oversight to ensure compliance with approved procedures, Good Documentation Practices (GDP), ALCOA+ principles, internal quality standards, and applicable regulatory requirements.
Ensure quality compliance across all product development activities, including process development, analytical method development, validation, qualification, technology transfer, scale-up studies, engineering batches, and stability programs.
Review laboratory notebooks, electronic laboratory records, worksheets, raw data, chromatograms, calculations, instrument printouts, and supporting documentation for accuracy, completeness, traceability, and compliance.
Oversee Quality Management System (QMS) activities, including change controls, deviations, investigations, CAPAs, risk assessments, document revisions, and effectiveness verification.
Participate in investigations related to development deviations, OOS, OOT, documentation errors, and process-related issues while ensuring effective corrective and preventive actions.
Assess quality and regulatory impact of proposed changes through the change management process.
Plan, coordinate, and conduct internal quality audits of R& D laboratories and development functions.
Prepare audit reports, communicate observations, monitor CAPA implementation, and ensure timely closure of audit findings.
Collaborate with cross-functional R& D teams to ensure effective implementation of quality systems throughout product development.
Support technology transfer activities by reviewing protocols, reports, risk assessments, and transfer packages.
Promote a strong quality culture by providing guidance on documentation practices, data integrity, quality risk management, and regulatory compliance.
Required Qualifications:
Master's Degree in Life Sciences or a related discipline.
10–15 years of experience in Development Quality Assurance within the pharmaceutical or biotechnology industry.
Mandatory experience in Biologics or Cell & Gene Therapy (CGT).
Strong knowledge of Quality Management Systems (QMS), Good Documentation Practices (GDP), ALCOA+ data integrity principles, and applicable global regulatory requirements.
Hands-on experience in quality oversight of product development, analytical development, process development, technology transfer, and stability studies.
Experience in investigations, CAPA management, change control, internal audits, and risk assessments.
Excellent communication, documentation, problem-solving, and stakeholder management skills.
Preferred Skills
Strong understanding of regulatory expectations governing biologics and Cell & Gene Therapy product development.
Experience working in cross-functional R& D environments.
Excellent leadership, collaboration, and decision-making capabilities.
Commitment to continuous improvement and quality excellence.
If you have the expertise and passion to drive quality throughout the development lifecycle and contribute to innovative biologics or Cell & Gene Therapy programs, we invite you to apply and become part of our growing team.