Manager Cluster Support - Quality

SUN PHARMA; Vadodara; Vor Ort; INR 1.500.000 - 2.300.000; Vollzeit

Zusammenfassung

Sun Pharma seeks a Cluster Office- Global Quality Operations Manager to lead quality and compliance across sites in Baroda. You will guide site quality, drive improvement programs, and ensure readiness for regulatory inspections, while aligning with global policies and quality standards.

The role requires 14–15 years in pharma, B.Pharm/M.Pharm, and deep GMP knowledge. Excellent communication with internal teams and external stakeholders is essential.

Qualifikationen

• Experience in pharmaceutical quality and manufacturing operations.
• Strong knowledge of GMPs across domestic and international regulatory environments.
• Excellent negotiation and stakeholder communication abilities.

Aufgaben

• Provide guidance to sites to achieve quality and compliance targets.
• Review major non-conformances and drive root cause analyses.
• Support audit readiness through site visits and document reviews.
• Coordinate with quality heads to prevent regulatory non-compliance and delays.
• Track quality performance metrics and drive improvement actions.
• Collaborate with QA, RA, IT and other functions to harmonize systems.

Kenntnisse

GMP Knowledge

Quality Systems

Regulatory Liaison

Strong Communication

Ausbildung

B.Pharm / M.Pharm

Jobbeschreibung

Job Description:

Job Title: Cluster Office- Global Quality Operations

Business Unit: Global Quality & Compliance

Job Grade: G10 / Manager-1

Location : Baroda

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 Summary: Provide guidance and support to Site Quality on closing non-compliances, lead enhancement projects related to product quality, compliance, and simplification, set milestones for effective execution of project actions, maintain substantial compliance at all sites by harmonizing and implementing Quality Systems and procedures in alignment with Global Policies and Standards, act as a champion for building a "Culture of Quality" across the organization, and assure that all sites are ready for all Regulatory and Customer inspections at all times.

Key responsibilities:

• Act as COE to provide guidance to Sites to ensure achievement of target for Quality & Compliance as per Management’s expectation.

• Review site investigation reports for major/critical non-conformances and share comments with site for improvement of root cause analysis.

• Support site for audit readiness by performing gap assessment through site visits and/or document review remotely for compliance enhancement and to track the action plan for remediation of gaps identified during Visit/Review.

• Support Quality Cluster Head in ensuring Quality or regulatory non-compliance issues don’t happen, which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the quality, financial performance and reputation of the company.

• Commonknowledge of regulatory guidelines of USFDA, MHRA, EU, ANVISA, WHO, Schedule M etc. and familiarity with GMP requirements of various regulatory bodies – USFDA/ MHRA/ HPRA/ ANVISA/ TGA/ WHO/ PMDA/CDSCO.

• Collaboratewith other Cluster Site Quality, SGO Heads, Supply Chain, Business Development, R&D, IT and RA for any specific requirement related to site Quality.

• Trackand monitor site performance for improving quality index. Identify the key challenges and improvement areas. Discussion with site on action plan for improvement.

• Reviewof batch rejection, market complaint, FAR/Recalls, Invalidated OOS - Monthly tracking, review and collation of details and discussion with site Quality for action plan.

• Trackand monitor Productivity / SLA /TAT from each site. Document productivity trends, Manpower analysis pending RM / PM (NMT 30 day) for release and report insights to Cluster Quality Heads.

• Supportthe development of central strategy to respond to system level audit observations, inspection findings and implement corrective actions across sites.

• Support for timely implementation of Quality owned harmonized IT solutions according to plan.

• Regularly updateon status of Regulatory inspection, CQA audit and upcoming inspection.

• Coordinatewith site for annual revenue and capex budget proposal including new headcount proposal. Work with Cluster Head to review and submit final proposal to corporate functions (Finance/HR/MDO), with

• Identifyand review Quality cost reduction initiatives as per management requirements.

• Review,discuss and track projects / initiatives /tasks (Cluster / Corporate) for completion and closure.

• Workclosely with Cluster Quality Head for reviews, identifying actionable points and ensuring closures.

Travel Estimate

Job Requirements

Educational Qualification: B.Pharm / M.Pharm

Experience: Experience14 to 15 Yrs in a pharmaceutical organization with good exposure of Quality and Manufacturing Operations.

Astrong knowledge of GMP’s in both domestic and international regulatory environments.

Strongcommunication skills and goal oriented.

Excellentnegotiation skills, relational skills and ability to communicate effectively with all levels of the organization and external stakeholders.

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).

Requirements: