Teva Pharmaceuticals
Website:
tevapharm.com
Job details:
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.
- 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
At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.
Already Working @Teva?
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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.
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