Sr Mgr Quality Assurance- On Site CMO Manager

We Are Teva

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. 
•    Cross-functional stakeholder management and leadership communication. 
•    External Manufacturing (ExM) quality systems and supply chain quality oversight.
Should also 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.

Long Description

Key Responsibilities

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.

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

Supply Chain & Inventory Visibility
•    Maintain oversight of material availability, including raw materials, packaging components, work-in-progress (WIP), and finished goods inventories.
•    Identify and communicate potential supply constraints that may impact manufacturing, release schedules, or customer supply commitments.
•    Collaborate with Supply Chain, Operations, and Quality teams to support uninterrupted product supply and proactive risk mitigation.

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.

Risk Management & Stakeholder Engagement
•    Proactively identify, assess, and escalate 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.

Your Skills and Experience

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


• 10+ 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

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