Associate Director, External Manufacturing Operations

Job Description

An opportunity has arisen for an External Manufacturing Operations Associate Director. Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time. 

Based out of the United States, the ExM Operations Associate Director is accountable for meeting customer demand at the Contract Manufacturing Organizations (CMOs) they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost. This is achieved through their direction as a key contributor within Focus Factory, and in partnership with those CMOs while leveraging lean manufacturing principles and the E2E supply chain.

You will be accountable for potentially new project support as well as commercial oversight between our Manufacturing Division and the CMO, by establishing strong business partnership as well as boundaries and ground rules of engagement.

You will steer a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement…) who are accountable for delivering daily/weekly/monthly/annual requirements at their external partner(s).

Bring energy, knowledge, innovation to carry out the following:

• Ensure compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand; Dispute resolution (w/ appropriate escalation); Production Planning;  Materials Management & Logistics; Technology issues; Oversight of shop floor production (determining when an ExM functional rep should be deployed to the External Party’s (EP) facility); Lean Manufacturing and Continuous Improvement activities; Linking E2E (upstream and downstream) and with Supply Chain Management ensure and optimize flow of materials

• Maintain a virtual presence at external partners site on the production floor either virtually or physically; builds a strong co-dependent relationship with the sites leadership team and can assess (“read a site”) & diagnose the current condition.  Assess risks at a partners site and formulate in partnership with the external partner and our Company cross-functional team action orientated and time bound improvement plans.  This may be executed virtually as well through use of innovative technologies that allow for remote sharing of information

• Partner with internal ExM team members including Procurement, Quality, Project management and Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required.  The External Manufacturing Operations Associate Director may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept apprised of status/resolutions, etc

• Participate in and represents External Manufacturing on the cross-functional teams with Supply Chain Management/Product Source Management/ Procurement/ Integrated Development and Supply Team for due diligence ahead of siting approval & post siting approval to support Source of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.

• Ensure there is a plan with clear actions and timelines in place to deliver SOS or NPI

• Work with the external partner to comprehend CMO capacity (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) and future capacity based on established improvements.

• Accountable for maintaining the integrity of the Master Supply Agreement ensuring alignment with the Supply and Quality agreements and appropriate document revision and distribution control and for ensuring contract terms established upon by our Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.

• Accountable for inventory control.  Based on the location of goods (at External Party or at our Company), External Manufacturing Operations Associate Director ensures adequate documentation of material disposition.  In some markets, External Manufacturing Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.

• Act as our Company operational excellence leader & coach for own team and works with external partner and lean manufacturing resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approve