Senior Manager / Manager – Development Quality Assurance

About the Role

We are looking for a Senior Manager or Manager in Development Quality Assurance (DQA) to join our team in Vapi, Gujarat. The position requires a professional with 10 to 15 years of experience who will lead the establishment, maintenance, and enhancement of the Quality Assurance system tailored for Research & Development activities. The ideal candidate should possess deep expertise in Biologics or Cell & Gene Therapy (CGT), with a strong background in quality systems, regulatory adherence, data integrity, and comprehensive quality oversight throughout the product development stages.

Key Responsibilities

• Create, revise, and periodically update SOPs, templates, and other quality-controlled documents that support R&D functions.
• Design, apply, and improve Development Quality Assurance systems continuously.
• Implement quality procedures for process, analytical, and formulation development, along with technology transfer, process characterization, and stability study support.
• Evaluate various R&D documentation such as SOPs, Work Instructions, Equipment Operating Procedures, specifications, protocols, reports, technical docs, and records related to method qualification, transfer, and technology transfer.
• Provide independent quality reviews ensuring adherence to approved procedures, Good Documentation Practices (GDP), ALCOA+ data integrity principles, internal standards, and relevant regulations.
• Oversee quality compliance across product development activities including validation, scale-up, engineering batches, and stability programs.
• Examine laboratory notebooks, electronic lab records, raw data, chromatograms, calculations, and related documentation to verify accuracy, completeness, traceability, and regulatory compliance.
• Manage Quality Management System (QMS) functions such as change controls, deviations, investigations, CAPAs, risk analyses, document updates, and validate their effectiveness.
• Lead investigations involving deviations, Out-of-Specification (OOS), Out-of-Trend (OOT) results, documentation errors, and process-related challenges and ensure appropriate corrective and preventive measures are implemented.
• Evaluate the quality and regulatory impact of proposed changes using established change management procedures.
• Organize and conduct internal audits of R&D laboratories and development operations to ensure compliance.
• Compile audit reports, communicate findings, monitor corrective actions, and ensure timely closure of audit points.
• Work collaboratively with cross-functional R&D teams to support quality system deployment during product development.
• Support technology transfer processes by reviewing relevant documentation, risk assessments, and transfer packages.
• Foster a quality-driven culture by guiding proper documentation practices, enhancing data integrity, managing quality risks, and complying with regulatory standards.

Required Qualifications

• Master's Degree in Life Sciences or a related field.
• Minimum of 10 to 15 years’ experience in Development Quality Assurance within pharmaceutical or biotechnology sectors.
• Essential experience in Biologics or Cell & Gene Therapy (CGT).
• Comprehensive knowledge of Quality Management Systems (QMS), Good Documentation Practices (GDP), ALCOA+ data integrity principles, and global regulatory standards.
• Demonstrated expertise in quality oversight of product/process development, analytical methods, technology transfers, and stability assessments.
• Proven experience handling investigations, CAPA processes, change control, internal audits, and risk evaluations.
• Strong communication abilities, skilled in documentation, problem resolution, and stakeholder engagement.

Preferred Skills

• In-depth insight into regulatory expectations for biologics and Cell & Gene Therapy development.
• Experience collaborating within cross-disciplinary R&D teams.
• Excellent leadership qualities, with strong teamwork and decision-making skills.
• Dedication to continuous quality improvement and excellence.