Role & responsibilities

- Act as primary quality contact/interface for assigned CMOs and suppliers, driving quality oversight and compliance management.
- Review and approve as needed QMS elements including deviations, investigations, LIRs, change controls, APR/PQRs, process validation documents, and SOPs.
- Monitor CMO cGMP compliance through governance meetings, quality risk assessments, and improvement plans.
- Lead quality support for product transfers, launches, supplier qualification, process changes, and product lifecycle management activities.
- Manage critical quality incidents, NTM/GNTM processes, investigations, complaints, CAPAs, and escalation of significant quality risks.
- Support regulatory inspections, customer audits, and health authority interactions, ensuring timely and effective responses.
- Ensure compliance with global regulatory requirements (USFDA, EU, Canada and other international markets) and post-approval change regulations.
- Establish and maintain Quality Technical Agreements (QTAs) and ensure supplier compliance with contractual quality requirements.
- Monitor quality KPIs, stability commitments, audit CAPAs, and supplier performance to drive continuous improvement.
- Proactive identification, assessment, and escalation of quality, compliance, operational, and supply risks, while providing timely reporting to External Manufacturing (ExM) Quality Leadership and relevant Teva functions to secure appropriate support, decision-making, and resolution of critical issues.

Should possess significant cross-functional knowledge in Supply Chain,



Regulatory Affairs, and MS&T.;

Supply Chain

- Sound understanding of end-to-end pharmaceutical supply chain processes, including procurement, demand and capacity planning, inventory management, manufacturing planning, distribution, and S&OP.;
- Working knowledge of key manufacturing and supply oversight processes, including:
- Manufacturing Schedule & Supply Assurance
- Real-time Batch Visibility & Risk Management
- Deviation, Investigation & Release Acceleration

MS&T;
- Strong knowledge of manufacturing processes for solid oral formulations.
- Experience collaborating with MS&T; teams on investigations and troubleshooting.
- Understanding of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), risk management, and data-driven decision-making.

Regulatory
- Basic understanding of regulatory requirements, product registrations, and post-approval changes across global markets.
- Awareness of ICH guidelines, GMP standards, and global regulatory expectations, with the ability to identify and escalate regulatory issues appropriately.

Qualifications & Experience:

- Bachelors/master’s degree in Pharmacy, Chemistry, or related field.
- 10+ years of experience in pharmaceutical quality assurance, with solid exposure to CMO management.
- Experience in Quality Management Systems and CMO oversight.
- Proficient in Track Wise, Veeva, regulatory compliance, and audit management.

Interested candidates can share profiles on [email protected] mentioning subject line as on site CMO Manager.

📌 On Site CMO Manager-Sr Manager Quality Assurance (Bengaluru)
🏢 Teva Pharmaceuticals
📍 Bengaluru