Sr. Manager - CMO Quality

Sun Pharmaceutical Industries Ltd; Maharashtra; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Sun Pharma in Mumbai seeks an experienced Manager CMO to ensure quality and compliance across global CMOs. The role focuses on overseeing QMS elements, change controls, deviations, investigations, and adherence to regulatory standards for injectable and OSd products.

Ideal candidates bring 12+ years in pharma QA and strong experience with global regulatory environments, contributing to continuous improvement and supplier oversight for emerging markets.

Qualifications

• 12+ years of pharmaceutical QA experience with injectable and OSd manufacturing exposure.
• Experience ensuring compliance with FDA, EMA, WHO, ICH and SUN internal quality systems.
• Ability to review batch records, validation protocols and analytical reports.

Responsibilities

• Participate in the initial evaluation of CMOs.
• Manage manufacturing operations at external contract sites.
• Lead and monitor QMS elements reported by CMOs, including change control and deviations.
• Oversee investigations of OOS/OOT results and complaints for injectables & OSd products.
• Ensure CMO operations comply with global regulatory standards and SUN systems.
• Review quality agreements with CMOs to ensure compliance and quality.
• Coordinate with SUN internal teams as needed.
• Minimum 12 years of pharma QA experience with injectables and OSd manufacturing for global markets.

Skills

Quality Assurance Oversight

Regulatory Compliance

CMO Management

Education

M.Sc / B.Pharm / M.Pharm

Job description

Job Title

Manager CMO

Business Unit

Global Quality & Compliance

Job Grade

G10 -Manager-1

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

To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities’ requirements are met and that all CMOs achieve, maintain and improve the adequate level of compliance, through “Quality Oversight” .

Key Responsibilities

• Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs).
• Should have experience in managing manufacturing operations at External contract manufacturing sites.
• Lead, oversee, approve & monitor Quality Management System (QMS) elements reported by CMOs, including change control, deviations, incidents, out of Specification (OOS)/out of Trend (OOT) results, and complaint investigations targeting for injectable & OSD products manufactured for emerging markets.
• Ensure that the CMO operations are in compliance with global regulatory standards (FDA, EMA, WHO, ICH) and SUN internal quality systems.
• Review and maintain quality agreements with CMOs to ensure compliance and quality standards.
• Review the batch records, validation protocols, and analytical reports for sterile injectable formulations & OSD Products manufactured for Emerging markets.
• Coordinate and support to SUN internal teams as on when necessary.
• Minimum 12 years of pharmaceutical QA experience, with strong exposure to injectable manufacturing and Oral solid dosage manufacturing operations for Global markets.

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

Tenure : 12+ years of Industry experience and working Knowledge in domestic and regulatory environments. Experience in handling quality managements systems .

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).