Please refer to JobSuchmaschine in your application
External Manufacturing Operations Director x 2
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
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 MSD cross functional teams and their work in partnership with those CMO’s while leveraging MPS and the E2E supply chain.
The ExMOD is the owner and primary point of contact for all dealings between MSD Manufacturing Division and the CMO 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.
Primary activities include but are not limited to: -
1. The External Manufacturing Operations Director (ExMOD) is a “Virtual Plant Manager” within ExM. They oversee MSD Manufacturing Division’s relationship with the contract manufacturer. The ExMOD serves as the air traffic controller of all information/interactions between MSD Manufacturing Division and the contract manufacturer and establishes boundaries and ground rules of engagement.
2. Is the leader of the MSD Manufacturing Division crossfunctional team (Supply Chain Quality, Technical Ops, Procurement…) who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).
3. Is accountable for all operational related activities:
a. Compliance (Quality Risk management, Deviation Management, Product Release, Change Control)
b. Meeting Demand
c. Dispute resolution (w/ appropriate escalation)
d. Production Planning
e. Materials Management (MRP entries, Logistics)
f. Technology issues
g. Oversight of shop floor production (determining when an EM functional rep should be deployed to the External Party’s (EP) facility)
h. OpEx and Continuous Improvement activities
i. Linking E2E (upstream and downstream) and with SCM in the Supply Chain to ensure and optimize flow of materials
4. Is frequently present at their external partners site on the production floor, builds a strong interdependent relationship with the sites leadership team and is able to (“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 the MSD cross-functional team action orientated and time bound improvement plans
5. 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.
6. 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 ExMOD will ensure there is a plan with clear actions and timelines in place to delivery this SOS or NPI.
7. 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
8. 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 MSD Manufacturing Division and the External Party are executed including purchase orders, forecasts, deliveries, and approving invoice payments.
9. Is accountable for inventory control. Depending on the location of goods (at External Party or at MSD), 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.
10. Acts as a MSD Production System (LSS) leader & coach for own team and works with external partner and MPS resources, as needed, to identify External Party OpEx / continuous improvement opportunities and supports implementation once approved. The ExMOD may commit resources provided MSD and the EP would share in the costs and benefits of such operational improvements.
11. Leads with the external partner periodic Business and Operations Review Meetings. Based on MSD 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 “state of the union” presentation for the relationships s/he manages which includes successes and failures in order to leverage across ExMOrg.
12. Lead strategic initiatives of network actions, World Class Supplier, Hoshin Kanri.
13. Participates in the creation and maintenance of an External Manufacturing Organization Handbook containing Global ExM
policies, procedures, templates, etc. The Ops Director prepares customized materials per product type where appropriate and also ensures training and adherence by Operations Managers within his/her area.
Plans strategically and understands the broad CMO business environment and specific opportunities & potential partners in their operations area
Education/Experience: Bachelors degree preferably in the Engineering, Science or Business and a minimum 12 years’ experience in commercial /business and manufacturing (operations, quality, technology, planning), roles required with a significant portion in management/leadership positions.
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 modality (API, Drug Product, Sterile). Direct Health Authority Audit experience desirable.
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 e business decisions that drive value for MSD and our customers.
Depth of Manufacturing Knowledge – Has proven skills and expertise at management level in modality (API, Drug Product, Sterile)
Strategic Thinking – Can Visualize the way forward, identifying 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
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
The location of the roles is flexible within Western Europe.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.