Sr. Manager - CMO Quality

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

Job summary

Sun Pharma in Mumbai is seeking a Manager CMO to ensure quality and compliance across contract manufacturing. You will oversee CMOs to maintain regulatory alignment for injectable and OSD products, review QMS, change controls, deviations, and investigations, and coordinate with internal teams.

Ideal candidates have 12+ years in pharmaceutical QA, strong knowledge of FDA/EMA/WHO/ICH standards, and hands-on experience with global quality systems in a manufacturing environment.

Qualifications

• Minimum 12 years of pharmaceutical QA experience.
• Experience with injectable manufacturing and OS? products for global markets.
• Experience in handling global regulatory standards (FDA, EMA, WHO, ICH).
• Experience reviewing quality agreements and ensuring compliance.

Responsibilities

• Participate in initial evaluation of Contract Manufacturing Organizations (CMOs).
• Manage manufacturing operations at external contract sites.
• Lead, oversee, approve & monitor Quality Management System (QMS) elements for CMOs (change control, deviations, incidents, OOS/OOT, investigations).
• Ensure CMO operations comply with global regulatory standards and SUN internal quality systems.
• Review batch records, validation protocols, and analytical reports for sterile injectables and OSD products for Emerging markets.
• Coordinate and support SUN internal teams as needed.

Skills

Quality Oversight

Regulatory compliance

Quality management

Education

MSc

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:

1. Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs).
2. Should have experience in managing manufacturing operations at External contract manufacturing sites.
3. 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.
4. Ensure that the CMO operations are in compliance with global regulatory standards (FDA, EMA, WHO, ICH) and SUN internal quality systems.
5. Review and maintain quality agreements with CMOs to ensure compliance and quality standards.
6. Review the batch records, validation protocols, and analytical reports for sterile injectable formulations & OSD Products manufactured for Emerging markets.
7. Coordinate and support to SUN internal teams as on when necessary.
8. 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).