Job Description

The External Manufacturing Operations Associate Director (ExMOAD), is accountable for meeting customer demand at the External Partner (EP) 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 EP's while leveraging our Production System principles (MPS) and the E2E supply chain.

The ExMOAD is the owner and primary point of contact for all dealings between our manufacturing divison and the EP and establishes a strong business partnership as well as boundaries and ground rules of engagement.

• ExMOAD is a "Virtual Plant Manager" within ExM. They oversee our relationship with the external partner.

• The ExMOAD serves as the air traffic controller of all information/interactions between our manufacturing and the EP leveraging the "Control Tower" and establishes boundaries and ground rules of engagement.

• Is the leader of the our manufacturing division cross-functional team (Supply Chain, Quality, Technical Ops, Procurement, and others) who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).

• Ensures 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 functional 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

• Partners with ExM Procurement, ExM Quality, and ExM Technology on commercial aspects of relationship, including Identify, Select, Negotiate and Re-negotiate/terminate, as required.

• Participates and represents ExM on the cross-functional teams with SCM/Product Source Management/Procurement/DCT 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 ExMOAD will ensure there is a plan with clear actions and timelines in place to deliver this SOS or NPI.

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

• Is accountable for inventory control. Depending on the location of goods (at External Party or at our company), ExMOAD 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.

• Acts as a our company Production System (MPS) 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.

• Leads with the external partner periodic Business and Operations Review Meetings. Based on our company and ExM strategy the ExMOAD develops with their cross functional team and their external partner the annual Hoshin Kanri Plan for the relationship with clear goals and targets. The ExMOAD 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 ExM Org.

• Lead strategic initiatives of network actions, World Class Supplier, Hoshin Kanri.

• Participates in the creation and maintenance of an External Manufacturing Organization Handbook containing Global ExM policies, procedures, templates, etc.

Requirements

• Bachelor's degree preferably in Engineering, Science or Business

• Minimum of 6 years of relevant experience

• Compliance - Has experience and ability to achieve compliance goals, through a risk-based approach has a deep understanding of GMP and EHS compliance and quality compliance risk.

• 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 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 skills 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

Preferred

• Minimum 8 years' experience in commercial /business and manufacturing preferred (operations, quality, technology, planning), roles required with a significant portion in management/leadership positions.

• Project Management Certification strongly preferred

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.

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Requisition ID:R326848