Sun Pharmaceutical Industries Ltd
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.
