Senior Specialist, External Manufacturing

Job Description

Are you ready to make a meaningful impact and drive innovation in the healthcare industry? The Global Pharmaceutical Organization (GPO) at our company is excited to invite passionate individuals to join our dynamic team!

GPO is a diverse global organization committed to bringing a compliant, reliable supply of life-saving and affordable medicines to patients around the world. Our organization is responsible for the manufacturing and supply of all pharmaceutical products, packaging of the entire Human Health portfolio and commercialization of the small molecule new product pipeline. GPO manages a wide range of products serving communities in more than 175 markets around the globe with more than 7 billion doses of vital medicine distributed each year. Collaborating with other operating units and functions, GPO's commitment to enhancing the patient experience and improving access to life-saving treatments is achieved through a network of internal and external sites that support the enterprise and division strategic priorities.

The External Manufacturing Operations Senior Specialist (ExMOSrS) is accountable for meeting customer demand at the External Partner (EP) they support by achieving excellence in Compliance, Supply, Continuous Improvement & Cost through their leadership and coaching of our company’s responsible cross-functional teams and their work in partnership with those EP’s while leveraging our company's Production System principles (MPS) and the E2E supply chain.

The ExMOSrS serves as a point of contact for dealings between our manufacturing division and the EP and supports a strong business partnership as well as boundaries and ground rules of engagement.

Primary Activities:

• ExMOSrS is Virtual Plant Management support within ExM. They support our manufacturing division's relationship with the external partner. 
• Leads / supports our manufacturing division cross-functional team (Supply Chain, Quality, Technical Ops, Procurement…) who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).
• Work with VCM (Value Chain Management) Lead and team (where applicable) and Product Technical Steward (where applicable) to support the designated products.
• Is accountable for operational related activities such as
• Ensuring compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning;  Materials Management (MRP entries, Logistics); Technology issues; Oversight of shop floor production (determining when an ExM funcional rep should be deployed to the External Party’s (EP) facility); OpEx and Continuous Improvement activities; Linking E2E (upstream and downstream) and with SCM (Supply Chain Management) to ensure and optimize flow of materials
• Proactively drive risk assessment across the whole value chain and work closely together with Focus Factory team and EP to manage and mitigate risks to aim at zero interruption of the supply chain and to ensure 100% compliance in quality and in environment, health and safety
• Builds a strong interdependent relationship with the site’s leadership team and can (“read a site”) assess & diagnose with appropriate tools and resource the true current condition & risks at a partners site and formulate in partnership with the external partner and our company’s cross-functional team action orientated and time bound improvement plans
• Partners with ExM Procurement, ExM Quality, and ExM Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required.  The ExMOSrS may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept appraised of status/resolutions, etc. 
• Participates and represents ExM on the cross-functional teams with SCM/Product Source Management/Procurement/IDST for due diligence ahead of siting approval & post siting approval to support SOS/NPI changes at an external party and assume primary ownership of the new relationship.  The ExMOSrS will ensure there is a plan with clear actions and timelines in place to deliver this SOS or NPI.
• The ExMOSrS works with the external partner to understand EP capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required etc.) and future capacity based on agreed improvements
• Is accountable 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 by our manufacturing