Sr Mgr Quality Assurance- On Site CMO Manager

Teva Pharmaceuticals; Mumbai; On-site; INR 1,800,000 - 2,800,000; Full time

Benefits offered by this job

Medical insurance

OPD coverage

Annual health checkups

Term life and accident insurance

Emotional wellbeing support

Meals at work

Job summary

Teva India is seeking an On-site CMO Manager – ExM Quality to lead quality oversight at CMOs and key suppliers, ensuring compliant manufacturing, release, and supply across global markets. You will drive QMS governance, risk management, and regulatory inspections with Teva quality standards, while supporting uninterrupted product supply.

The role requires 12+ years in pharma QA, strong CMO exposure, TrackWise, and Veeva expertise, plus cross-functional leadership in a fast-paced environment.

Qualifications

• Bachelor’s/Master’s degree in Pharmacy, Chemistry, or related field.
• 12+ years of experience in pharmaceutical quality assurance, with strong exposure to CMO management.
• Experience in Quality Management Systems and CMO oversight.
• Proficient in TrackWise, Veeva, regulatory compliance, and audit management.

Responsibilities

• Quality oversight of CMO/sites and supplier quality management.
• Ensure cGMP compliance and quality systems across external manufacturing operations.
• Lead regulatory readiness, inspections, and risk management.
• Coordinate product transfers, lifecycle changes, and release readiness with ExM.

Skills

Quality assurance

CMO management

Quality Management Systems

Audit management

Education

Bachelor’s/Master’s degree in Pharmacy, Chemistry, or related field

Tools

TrackWise

Veeva

Job description

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Our Team, Your Impact

The On-site CMO Manager – ExM Quality serves as the Quality lead located at assigned Contract Manufacturing Organizations (CMOs) and key suppliers, ensuring compliant manufacturing, release, and supply of Teva products across global markets. The role provides end-to-end quality oversight, risk management, and QMS governance for external manufacturing operations, ensuring adherence to cGMP requirements, regulatory expectations, Teva quality standards, and Quality Technical Agreements while supporting uninterrupted product supply

How You’ll Spend Your Day

• Pharmaceutical QMS (Deviations, CAPA, Change Control, Investigations, APR/PQR, Validation, SOPs).


• CMO/Supplier Quality Management and cGMP compliance oversight.


• Global regulatory requirements (USFDA, EMA, Health Canada, and international markets).


• Product transfers, commercialization, process changes, and lifecycle management.


• Quality risk management, NTM/GNTM, complaint handling, and escalation management.


• Regulatory inspections, customer audits, and health authority interactions.


• Quality Technical Agreements (QTA) and supplier qualification programs.


• Quality KPIs, audit CAPAs, stability programs, and continuous improvement initiatives.


• Cross-functional stakeholder management and leadership communication.


• External Manufacturing (ExM) quality oversight.


• Should also possess basic knowledge in Supply Chain, Regulatory Affairs, and MS&T processes.

Long Description

Shop Floor Quality Oversight

• Serve as Teva's on-site quality representative, maintaining a strong quality presence across CMO site operations.


• Participate in daily production and operational review meetings to provide quality oversight and ensure alignment with production objectives.


• Monitor adherence to cGMP requirements, approved procedures, and quality standards through routine shop floor engagement.


• Provide real-time visibility and escalation of critical quality events, deviations, compliance concerns, and operational risks.

Manufacturing Operations Monitoring

• Provide continuous oversight of manufacturing activities to ensure uninterrupted execution of production plans and supply commitments.


• Monitor production schedules, batch progression, and operational performance to identify potential delays, bottlenecks, and execution risks.


• Maintain visibility of equipment downtime, resource constraints, and operational challenges that may impact product quality or supply continuity.


• Escalate emerging risks and critical issues to relevant Teva stakeholders in a timely manner to support proactive decision-making and issue resolution.

Investigation, Quality Systems & Execution Support

• Support and provide effective challenges during investigations to ensure robust root cause identification and sustainable corrective actions.


• Monitor investigation progress and ensure timely closure of deviations, CAPAs, and quality actions.


• Verify implementation and effectiveness of corrective and preventive actions to drive continuous compliance improvement.


• Partner with site quality and operations teams to facilitate timely batch documentation review, record closure, and release readiness activities.

Operational Excellence & Continuous Improvement

• Drive and support site-level quality, compliance, and operational excellence initiatives.


• Partner with cross-functional teams to identify opportunities for process improvement, simplification, and performance enhancement.


• Support Lean and Operational Excellence programs to improve efficiency, compliance, and manufacturing reliability.


• Provide independent assessments and insights on site performance, quality culture, and operational effectiveness through regular reporting and governance forums.

Risk Management & Stakeholder Engagement

• Proactively identify, assess, and elevate quality, compliance, operational, and supply risks to ensure timely mitigation and resolution.


• Act as the primary on-site liaison between the CMO and Teva's External Manufacturing (ExM) Quality organization.


• Provide timely and actionable reporting to ExM Quality Leadership and relevant Teva functions to enable informed decision-making and rapid issue resolution.


• Facilitate effective communication, collaboration, and alignment between site personnel and Teva stakeholders to support business and quality objectives.

Your Skills and Experience

• Bachelor’s/master’s degree in Pharmacy, Chemistry, or related field.


• 12+ years of experience in pharmaceutical quality assurance, with strong exposure to CMO management.


• Experience in Quality Management Systems and CMO oversight.


• Proficient in TrackWise, Veeva, regulatory compliance, and audit management.

How We’ll Take Care of You

At Teva India, care is at the heart of how we work. From your first day, you’ll be welcomed into a people-first culture built on inclusion, respect, and belonging.

That support extends to you and your loved ones through benefits designed for real life. These include comprehensive medical insurance, OPD coverage, annual health checkups, term life and accident insurance, and confidential emotional wellbeing support through our Optum Employee Assistance Program. You’ll also enjoy healthy meals at work, holistic wellbeing initiatives, and volunteering programs that help you give back to the community.

Your growth matters too. You’ll have opportunities to build future‑ready skills, collaborate on projects with global teams, explore internal career opportunities, and learn through programs such as our AI-enabled Teva Twist program, R&D Academy, continuing education, and mentorship.

Join our vibrant workplace, where we celebrate milestones, festivals, achievements, and community impact together.

Already Working @Teva?

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

EOE including disability/veteran