About this role
1. Strategic Leadership & Business Planning
- Develop and implement the long-term strategy for CMO operations in alignment with business objectives.
- Identify, evaluate, and onboard CMOs based on technical capability, capacity, compliance history, and cost competitiveness.
- Establish long-term capacity and sourcing plans to support product launches and market expansion.
- Drive business continuity planning and risk mitigation for external manufacturing operations.
2. Planning, Coordination & Supply Chain Alignment
- Lead end-to-end planning activities for CMO operations including demand planning, supply planning, and material planning.
- Collaborate with Supply Chain, Production Planning, and Procurement teams to ensure accurate demand forecasts and production schedules.
- Oversee allocation of production across CMOs based on capacity utilization, lead times, and cost considerations.
- Ensure alignment between internal planning teams and external CMOs for production timelines, shipment schedules, and inventory management.
- Monitor and review monthly production plans, capacity load, and material availability to ensure uninterrupted supply.
- Coordinate with vendors for timely availability of APIs, excipients, and packaging materials required for CMO batches.
- Review supply chain KPIs such as forecast accuracy, adherence to production plans, and material readiness.
3. Operational Oversight & Execution
- Ensure smooth execution of manufacturing operations at CMOs as per approved plans and timelines.
- Review weekly and monthly production performance against plan and initiate corrective actions where necessary.
- Drive operational excellence through continuous improvement in productivity, yield, and turnaround time.
- Conduct periodic site visits to monitor performance, resolve operational bottlenecks, and enhance process capability.
4. Quality, Compliance & Regulatory Management
- Ensure all CMO facilities operate in full compliance with cGMP and company quality standards.
- Partner with QA/QC and Regulatory teams for audits, product filings, and inspection readiness.
- Oversee quality metrics, deviations, change controls, and CAPA closures in coordination with the Quality team.
- Support CMO sites during regulatory audits (USFDA, EMA, WHO, MHRA, etc.) and ensure continuous compliance readiness.
5. Technical & Process Support
- Collaborate with Technical Services, R&D, and Technology Transfer teams for new product introductions and process validations.
- Provide technical oversight for scale-up, troubleshooting, and optimization of manufacturing processes at CMOs.
- Ensure technical agreements and manufacturing instructions are updated and adhered to.
6. Vendor & Stakeholder Management
- Serve as the primary point of contact for all CMO and vendor interactions.
- Conduct regular business review meetings with CMOs to evaluate performance (Quality, Delivery, Cost, and Compliance).
- Develop strong partnerships with CMO leadership teams to foster transparency and mutual growth.
- Coordinate cross-functionally with internal teams — Quality, Regulatory, SCM, Finance, and R&D — for seamless execution.
7. Cost & Performance Management
- Manage CMO operational budgets and drive cost optimization through efficiency initiatives and strategic sourcing.
- Monitor and report KPIs: cost per batch, OTIF (On-Time In-Full) delivery, rejection rates, yield, and resource utilization.
- Identify and implement productivity and cost-reduction initiatives across CMOs.
8. People Leadership
- Lead and mentor a team responsible for CMO operations, planning, and coordination.
- Build team capability in vendor management, technical assessment, and production planning.
- Promote a culture of collaboration, accountability, and performance excellence.
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Other facts
About Amneal India
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.
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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.
What you'll do
- The Senior General Manager will develop and implement long-term strategies for CMO operations while ensuring compliance with quality standards. They will oversee planning, coordination, and operational execution to support product launches and market expansion.
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