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.
- Solid 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.

📌 Manager – Development Quality Assurance (Gurugram)
🏢 Qvents.In
📍 Gurugram