Job Title: Manager-Clinical Quality & Process **Business Unit:** Global Development Centre **Job Grade** G10 **Location :** Gurgaon/ Mumbai At Sun Pharma, we commit to helping you **Create your own sunshine** by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. **Are You Ready to Create Your Own Sunshine?** As you enter the Sun Pharma world, youll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a team-oriented spirit, knowing that we Thrive together and support each others journeys. **Job Purpose** The Clinical Process and Quality Manager (CPQM) is responsible for enabling Sponsor Oversight, Quality Control, and Risk-Based Quality Management (RBQM) across global clinical development activities in alignment with ICH E6(R3). The role will support all Global Development Organization (GDO) functions and shall ensure that quality is built into trial design and conduct, sponsor accountability is maintained despite delegation, and trials remain inspection-ready throughout their lifecycle. **Key Responsibilities:** + **Sponsor Oversight & Accountability:** + Maintains **documented Sponsor Oversight frameworks** , ensuring appropriate oversight of CROs, vendors, and investigational sites based on trial complexity, risk, and criticality of activities. + Ensures that delegation of trial activities does not absolve **Sponsor accountability** , and that oversight mechanisms remain effective throughout the trial lifecycle. + Provides **independent assessment** and **escalation** of quality risks, compliance gaps, and emerging signals to appropriate governance bodies. + Supports senior leadership in demonstrating active **Sponsor oversight** during **audits and regulatory inspections** + Provides quality oversight **of CROs, vendors, and partner organizations** , assessing performance against contractual obligations, quality expectations, and regulatory requirements. + **Integrated Quality Control (IQC) Activities:** + Plans, leads, and conducts risk-based IQC activities, including: + In-house process and documentation **risk-based IQC** **reviews** + Remote and on-site **QC visits** + Focused reviews of **high-risk processes, data, vendors,** and **sites** + Ensures QC activities provide independent verification of trial conduct, data credibility, and compliance with protocol, SOPs, and regulatory requirements. + **Documents QC outcomes** clearly, ensuring **traceability** ,



inspection readiness + **Risk-Based Quality Management (RBQM):** + Leads **RBQM** in accordance with ICH E6(R3), ensuring quality is proactively planned, implemented, monitored, and improved throughout the trial lifecycle. + Supports study teams in identifying **Critical-to-Quality (CtQ) factors** , including critical data, processes, and endpoints impacting subject safety and data reliability. + Contributes to the development and maintenance of **study-level risk assessments** , **Quality Management Plans,** and **oversight strategies** . + Performs **ongoing risk review** and **signal detection** using QC findings, metrics, KPIs, KRIs, centralized monitoring outputs, and trend analysis. + Ensures that quality actions are risk-proportionate, focused on **preventing issues** rather than detecting errors retrospectively. + **Audit, Inspection & Issue Management:** + Supports **audit and regulatory inspection readiness** , including preparation, participation, response development, and postinspection follow-up, as assigned. + Ensures that QC, audit, and inspection findings are adequately **investigated** , **root causes** are appropriately identified and **CAPAs are effective and sustainable** . + Collaborates with QA, GDO functions, and service providers to manage **serious GCP non-compliance, quality events** , and **potential scientific misconduct** , including appropriate documentation, escalation, and governance oversight. + **Reporting and Governance:** + Provides periodic, structured quality and **oversight reports** to stakeholders, including IQC outcomes, risk assessments and trends, RBQM effectiveness and key quality risks and mitigation status + Performs **trend analysis** of all IQC findings to identify systemic issues, recurring risks, including identification of any process gaps and recommends appropriate actions. + Ensures **lessons learned** are translated into process improvements, training updates, and enhanced oversight models. + **Quality Systems, Processes & Continuous Improvement:** + Reviews, develops, and supports implementation of **SOPs,** controlled documents, and training programs relevant to Sponsor Oversight and RBQM.



+ Monitors **adherence to SOPs** and report on compliance issues, works with assigned GDO function heads to address any deviations or areas of improvement. + **Supports QA** in QMS implementation and other quality initiatives, as and when needed. + Evaluates the impact of evolving international and national regulations and guidelines on clinical development operations. + Actively contributes to continuous improvement initiatives within department. **Qualification, Skill and Competencies Requirements** + **Advanced degree** in Medicine/Pharmacy/Life Sciences; Masters preferred. + **10+ years global clinical research experience** , including sponsor oversight and on-site monitoring of multicentric trials. + Strong expertise in ICHGCP, global regulations, and sponsor accountabilities. + Proven experience in **clinical quality management,** including QMS, risk-based quality oversight, trend analysis, and CAPA. + Experience managing **audits, inspections, and inspection readiness activities** . + **Effective oversight** of CROs, vendors, and investigators, including management of quality issues and escalations. + **Excellent stakeholder engagement, communication, and negotiation skills** . Willingness to **travel up to 30%.** **Your Success Matters to Us** At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. _Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Lets create a brighter future together!_ **_Disclaimer:_** _The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s)._ We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

📌 Manager-Clinical Quality & Process (India)
🏢 Sun Pharmaceuticals
📍 India