10 Aug
|
Sun Pharmaceutical Industries
|
Gurugram
10 Aug
Sun Pharmaceutical Industries
Gurugram
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 workplace 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 regulator
📌 Manager-Clinical Quality (Gurugram)
🏢 Sun Pharmaceutical Industries
📍 Gurugram