Operations Manager (External Manufacturing / ExM)
- Category: Pharmaceutical
- Location: City of Dublin
- Date: 1 month ago
We are one of the largest, best known Pharmaceutical companies in the industry and our products are known globally.
We are looking to recruit an Operations Manager within External Manufacturing (ExM) to join us on an initial 11 month contract. You will work closely with the Operations Director / Virtual Plan Manager to provide support to External Manufacturing Partners.
This role will support Pediatrics and Spray Dried Intermediates within the Drug Product/Devices Platform.
Key Responsibilities Include:
* Represent the VPM in forums as delegated by the VPM
* Routine presence at external partners site on the production floor. Building a strong relationship with the site team and able to assess & diagnose with appropriate tools and resource the true current condition & risks at a partner’s site.
* Works closely with internal and external partner to understand capacity and future capacity based on agreed improvements
* Responsible for maintaining the integrity of the MSA (Master Supply Agreement) ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms agreed upon are executed, including purchase orders, forecasts, deliveries, and approving invoice payments.
* Responsible for inventory control.
* Supports Business and Operations Review Meetings and the annual Hoshin Kanri Plan for the relationship with clear goals and targets, and annual “state of the union” presentation for the relationships s/he manages which includes successes and failures in order to leverage across ExM.
* Supporting the VPM, plans strategically, understands broad CMO business environment, specific opportunities & potential partners in their operations area
Specific to Commercialization of Pediatrics and Spray Dried Intermediate Products:
* Responsible to ensure fulfilment of operations activities related to commercialization, new product introduction and commercial supply of pediatric and spray dried intermediate products.
* Ensure commercial item code creation
* Ensure shipping lane set up and qualification of product in the shipping lane
* Ensure Product standard cost set up
* Cold chain management system setup at external partner
* Understand product importation and exportation requirements
* Operations support for Product PPQs
* Operations support for packaging and artwork
* Is a delegate for the VPM as required
Experience and Skills Required:
* Bachelor’s degree minimum, with a degree in Engineering or Science and Business is preferred
* No less than seven (7) years’ experience in pharmaceutical manufacturing (operations, quality, technology, supply chain) roles with a significant portion in management/leadership positions
* Supply chain excellence knowledge and experience preferred
* Compliance – Deep understanding of GMP and EHS compliance and compliance risk
* World Class Supplier Mindset – proven Lean Six Sigma skills
* Business & Financial Acumen
* Depth of Manufacturing Knowledge
* Knowledge of SAP
Please press apply now to submit your application. Alternatively, if you would like further information on this position or other positions win a similar sector, please feel free to contact Shaunna Doherty on (phone number removed) for a confidential conversation.
We are an equal opportunities Business. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
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