Job Detail

JOB DESCRIPTION

Job Description

The External Manufacturing Operations Director (ExMOD), is accountable for meeting customer demand at the Contract Manufactures they manage by achieving excellence in Compliance, Supply, Continuous Improvement & Cost through their leadership and coaching of the responsible cross functional teams and their work in partnership with those Contract Manufacturing Operations’s (CMOs) while leveraging lean principles and an end to end supply chain perspective.

This specific role will manage the Operations interface for site(s) associated with Organon, a strategic partner. The ExMOD will oversee the activities that support the stand-up and stabilization of the supply relationship.  The role will require strong influence, leadership and communication skills to drive business outcomes.  The role will require significant time at the manufacturing sites of responsibility in order to ensure ongoing success. 

Primary Activities

Primary activities include, but are not limited to:

The ExMOD is the owner and primary point of contact for all dealings between the our Manufacturing Division, and the CMOs and establishes a strong business partnership as well as boundaries and ground rules of engagement. ExMODs will typically manage relationships that are highly complex in nature and of strategic importance.

• The External Manufacturing Operations Director (ExMOD) is a "Virtual Plant Manager" within ExM. Overseeing relationship with the contract manufacturer belongs to primary responsibility. The ExMOD manages all information/interactions between our manufacturing division and the contract manufacturer and establishes boundaries and ground rules of engagement.


• The Virtual Plant Manager is the leader of the manufacturing cross functional team (Supply Chain, Quality, Technical Ops, Procurement…) who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).  The team is responsible for ensuring appropriate performance management and strategies to guarantee the external partner meets or exceeds expectations 


• ExMODs are accountable for all operational related activities:
  
  
  
  • Compliance (Quality Risk management, Deviation Management, Product Release, Change Control); Meeting Demand, Dispute resolution; Production Planning; Materials Management (MRP entries, Logistics); Technology issues; Oversight of shop floor production (determining when an EM functional rep should be deployed to the External Party’s facility); Operational Excellence and Continuous Improvement activities; Linking upstream and downstream and Supply Chain to ensure and optimize flow of materials
  
  


• ExMODs are frequently present at their external partners site on the production floor, builds a strong interdependent relationship with the site’s leadership team and is able to 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 the our cross-functional team action orientated and time bound improvement plans


• ExMODs 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 ExMOD 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.


• Participates and represents ExM on the cross-functional teams with SCM/Product Sourcing


• ExMODs also support Management/Procurement/New Product for due diligence ahead of siting approval & post siting approval to support Sourcing/New Product changes at an external party and assume primary ownership of the new relationship. The ExMOD will ensure there is a plan with clear actions and timelines in place to deliver the source of supply change or new product introduction.


• The ExMOD works with the external partner to understand EP capacity (e.g. stated capacity, firm capacity, future capacity plans, time horizon / lead times required, comments/concerns, etc.) and future capacity based on agreed improvements


• The ExMOD 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 division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.


• The ExMOD is accountable for inventory control, depending on the location of goods (at External Party or at our company), ExMOD ensures adequate documentation of material disposition. In some markets, ExM Operations may need to witness the destruction of goods (to prevent counterfeiting) or have the External Party certify the destruction, per destruction procedures.


• The ExMOD acts as a Production System, MPS, (Lean) leader & coach for own team and works with External Partner, EP, and MPS resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved. The ExMOD may commit resources provided by our company and the EP would share in the costs and benefits of such operational improvements.


• The ExMOD leads, with the external partner, periodic Business and Operations Review Meetings. Based on our company and ExM strategy the ExMOD develops with their cross-functional team and their external partner the annual Hoshin Kanri Plan for the relationship with clear goals and targets. The ExMOD also prepares an annual presentation for the relationships s/he manages which includes successes and failures in order to leverage across ExMOrg.

Skills (include specific skill levels required to apply our Leadership Principles)

Education/Experience: 

• Bachelor’s degree minimum in the Engineering, or Science preferred


• Minimum twelve (12) years’ experience in API/pharmaceutical manufacturing (operations, quality, technology, supply chain).


• Demonstrated experience in management/leadership positions.


• Demonstrated experience in managing a complex portfolio of projects.

Skills: 

• Compliance – Has experience and ability to achieve compliance goals, through a risk based approach; Has a deep understanding of GMP and EHS compliance and compliance risk in API manufacturing


• World Class Supplier Mindset – Has proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time


• Business & Financial Acumen – Has skills to understands and intelligently apply economic, financial and industry data to make business decisions that drive value for our company and our customers.


• Depth of Manufacturing Knowledge – Has proven skills and expertise at management level API platforms. 


• Strategic Thinking – Can identify opportunities that add value to the work and proactively mitigate risk across the value chain


• Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, negotiation to work outside boundaries as a norm


• Business Outcomes /Drive Results – Ability to use deep knowledge and expertise in production operations to drive results and business outcomes


• Candidate must be accomplishment oriented (self-motivated and persistent), possess a "business owner" mentality, possess the ability to influence without authority, and demonstrate the ability to effectively operate in an ambiguous/changing environment. 


• End to End Mindset – Ability to apply understanding of end-to-end supply chain within external and internal network and stakeholders across the network to achieve results and contribute supply chain optimization


• High Performing Teams – Demonstrated ability to build, foster and lead high performing teams to achieve goals and exceed expectations

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R98077