Title:  Senior Manager - Quality IT Compliance

Job Title:

Sr.Manager Quality IT Compliance

Business Unit:

Global Quality & Compliance

Job Grade

G9A

Location :

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 Summary :

Responsible for developing, applying appropriate quality systems to ensure Computer Systems, projects, processes and services meet their business and regulatory requirements. Follow overall GxP strategic direction for all IT Quality activities and ensure consistent compliance of GxP IT Systems with regulations and corporate quality policies, programs and objectives. Support building a “culture of quality” across the organization. Assess compliance and operational issues of the Company, providing strong leadership, expertise and setting and maintaining IT - Quality standards throughout the Company’s complete value chain.

Key responsibilities:

• Provide Quality ownership and oversight for IT systems (Site and Corporate) used in GxP and regulated activities.
• Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, ICH, ALCOA+, and global data integrity expectations.
• Define and maintain Quality SOPs, policies, and standards related to IT systems and digital solutions.
• Serve as the Quality SPOC for IT-related internal audits, external audits, and regulatory inspections.
• Review and approve audit responses, CAPAs, and remediation plans related to IT systems.
• Conduct proactive compliance assessments and inspection readiness activities.
• Ensure implementation and monitoring of data integrity controls across systems
• Provide Quality guidance during system selection, implementation, and global rollouts.
• Develop and deliver Quality training on IT compliance, CSV, and data integrity.
• Champion a strong quality and compliance mindset across digital initiatives

Travel Estimate

Job Requirements

Educational Qualification

M.Sc / B.Pharm / B.E

Experience

Tenure:  15 to 16 Yrs

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).