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Full-time
postgraduate degree
Professional growth opportunities, Supportive community environment
Posted 5d ago
Apply by Aug 28
~40 hrs/week
Responsibilities
The Clinical Process and Quality Manager is responsible for enabling sponsor oversight, quality control, and risk-based quality management across global clinical development activities. They ensure trials remain inspection-ready and compliant with ICH E6(R3) standards while managing vendor performance and quality risks.
Requirements
Candidates must hold an advanced degree in Medicine, Pharmacy, or Life Sciences with at least 10 years of global clinical research experience. Strong expertise in ICH-GCP, regulatory compliance, and clinical quality management systems is essential for this role.
Full job description
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, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s 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 IQCreviews
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.
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 post‑inspection 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.
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; Master’s preferred.
10+ years’ global clinical research experience, including sponsor oversight and on-site monitoring of multi‑centric trials.
Strong expertise in ICH‑GCP, 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. Let’s 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).
Sun Pharma is the world's fourth-largest speciality generic pharmaceutical company and No. 1 in India. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries. Sun Pharma's global presence is supported by more than 40 manufacturing facilities spread across 5 continents, R&D centres across the globe, and a multicultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising around 3,000 scientists and R&D investments of over 6-8% of annual revenues.
At Sun, our people are our greatest asset. Ours has never been a story of individual brilliance but of cultivating a culture of realising collective potential. In our journey, everyone is enabled to take charge in an environment that offers limitless growth opportunities. We are with you every step of the way, so you can shine for years to come.
With the launch of our Employee Value Proposition (EVP), we define our promise to ‘Create Your Own Sunshine'—driven by the three pillars of Better Every Day, Take Charge, and Thrive Together. These pillars drive progress at Sun so that people can achieve what they would have thought impossible. Learn more about our EVP here: https://sunpharma.com/careers/
Offices: Sun House, CTS No. 201 B/1,, Western Express Highway, Goregaon East, Mumbai, Maharastra 400063, IN
Sun Pharma is the world's fourth-largest speciality generic pharmaceutical company and No. 1 in India. We provide high-quality, affordable medicines trusted by customers and patients in over 100 countries. Sun Pharma's global presence is supported by more than 40 manufacturing facilities spread across 5 continents, R&D centres across the globe, and a multicultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising around 3,000 scientists and R&D investments of over 6-8% of annual revenues.
At Sun, our people are our greatest asset. Ours has never been a story of individual brilliance but of cultivating a culture of realising collective potential. In our journey, everyone is enabled to take charge in an environment that offers limitless growth opportunities. We are with you every step of the way, so you can shine for years to come.
With the launch of our Employee Value Proposition (EVP), we define our promise to ‘Create Your Own Sunshine'—driven by the three pillars of Better Every Day, Take Charge, and Thrive Together. These pillars drive progress at Sun so that people can achieve what they would have thought impossible. Learn more about our EVP here: https://sunpharma.com/careers/
Offices: Sun House, CTS No. 201 B/1,, Western Express Highway, Goregaon East, Mumbai, Maharastra 400063, IN