Sr.Manager- CMO

SUN PHARMA; Mumbai; On-site; INR 2,700,000 - 3,800,000; Full time

Job summary

Sun Pharma in Mumbai seeks a Manager / Sr. Manager CMO to lead Quality & Compliance for global markets. You will oversee external manufacturing operations and drive QMS-based governance across CMOs, ensuring alignment with FDA, EMA, WHO, and ICH standards.

The role requires 14+ years in pharmaceutical QA, with injectable manufacturing exposure for regulated markets. Collaboration with Regulatory Affairs, Manufacturing and Supply Chain is essential to maintain highest quality and inspection

Qualifications

• Minimum 13 years of pharmaceutical QA experience.
• Strong exposure to injectable manufacturing operations for regulated markets.
• Experience handling Quality Management Systems (QMS).
• Experience in evaluating CMOs and maintaining quality agreements.

Responsibilities

• Evaluate CMOs supporting initial assessments and oversee QMS elements (change control, deviations, incidents, OOS/OOT, investigations).
• Ensure CMO operations comply with global regulatory standards (FDA, EMA, WHO, ICH) and SUN quality systems.
• Review batch records, validation protocols, and analytical reports for sterile injectables for USA markets.
• Collaborate with Regulatory Affairs, Manufacturing and Supply Chain to assure product quality and compliance.
• Drive continuous improvement and inspection readiness at CMOs.

Skills

Quality Oversight

QMS Management

Regulatory Knowledge

Cross-functional Collaboration

Education

M.Sc / B.Pharm / M.Pharm

Job description

Job Title

Manager / Sr.Manager CMO

Business Unit

Global Quality & Compliance

Job Grade

G10 -Manager-1 / G9B (SM-2)

Location :

Mumbai

Are You Ready to Create Your Own Sunshine?

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.

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" for USA Markets.

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 formulation for USA Market.
• Support for the project management team during the execution of exhibit/scale-up batches at the CMO site.
• Collaborate with cross-functional teams including Regulatory Affairs, Manufacturing, and Supply Chain to ensure product quality and compliance .
• Drive continuous improvement initiatives and inspection readiness at CMOs
• Minimum 13 years of pharmaceutical QA experience, with strong exposure to injectable manufacturing operations for Regulated markets.

Travel Estimate

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

Tenure : 14+ years of Industry experience and working knowledge in 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).