Manager – Development Quality Assurance

Designation : Manager

Function : DQA

Functional Area : Developmental QA - Clinical Studies

Job Role Summary : Manager, Development Quality Assurance (Inspection Readiness) within the Global Development Organization (GDO) is responsible for establishing, maintaining, and advancing global regulatory inspection preparedness. The Manager/Sr Manager will act as a strategic partner to Clinical Development and Operations, Quality, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and external partners to instill inspection preparedness into routine operations and foster a culture of inspection excellence.

Job Profile

• Design, implement, and maintain a global clinical inspection preparedness framework across GDO asset programs in collaboration with cross‑functional stakeholders.
• Partner with the VP and Head of Development QA to define inspection readiness KPIs and contribute to governance reporting, dashboards, and risk monitoring activities.
• Drive ongoing preparedness activities, including mock inspections, gap assessments, and targeted readiness health checks.
• Embed inspection preparedness throughout the clinical trial lifecycle, including start‑up, conduct, and close‑out phases.
• Serve as the primary inspection readiness lead for Health Authority inspections at the Princeton, NJ site and partnering closely with regional inspection teams at global facilities.
• Oversee inspection preparation, execution, and follow‑up activities, including document readiness, inspection logistics, and SME preparation and coaching.
• Lead inspection response activities, including daily debriefs, Health Authority interactions, post‑inspection commitments, and CAPA development and tracking.
• Identify systemic inspection risks and lead mitigation, remediation, and continuous improvement initiatives.
• Ensure timely and effective completion of inspection‑related CAPAs and audit actions, monitoring effectiveness and sustainability.
• Communicate inspection risk, compliance posture, and readiness status to key stakeholders and senior leaders.
• Facilitate cross‑functional forums, training sessions, and lessons‑learned workshops in partnership with project management colleagues.
• Contribute to inspection/audit oversight of CROs, vendors, and other external partners to ensure preparedness.
• Develop and deliver inspection preparedness training and coaching for internal teams, clinical sites, and designated SMEs.
• Support onboarding and ongoing inspection preparedness education for new programs and personnel

Job Requirements

• Significant experience in Clinical Quality, Clinical Operations, and/or Regulatory Compliance.
• In‑depth understanding of R&D regulatory requirements and inspection expectations.
• Direct and recent experience supporting or leading global GxP regulatory inspections.
• Strong working knowledge of GxP regulations, ICH guidelines, and global inspection processes and CAPA.
• Experience collaborating with CROs and third‑party vendors.

Work / Job Experience : 10+ Years

Type of Experience : Global clinical inspection preparedness, Clinical QA

Academic Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related discipline; Master’s degree preferred.
• Master’s degree preferred.

Job Post Link : https://tinyurl.com/y3a6hzwy

• Full Time
• India | Haryana | Gurgaon
• Posted 50 mins ago

Website Linkedin Sun Pharmaceutical Industries Ltd

To apply for this job please visit careers.sunpharma.com.