Job Description
The External Manufacturing Operations Associate Director, is accountable for meeting customer demand at the Contract Manufactures (CMO's) 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 CMO's while leveraging lean manufacturing principles and the E2E supply chain.
The External Manufacturing Operations Associate Director is the owner and primary point of contact for all dealings between our Manufacturing Division and the CMO and establishes a strong business partnership as well as boundaries and ground rules of engagement. External Manufacturing Operations Associate Director is a "Virtual Plant Manager" within External Manufacturing. They oversee our Manufacturing Division relationship with the contract manufacturer.
The External Manufacturing Operations Associate Director serves as the air traffic controller of all information/interactions between our Manufacturing Division and the contract manufacturer leveraging the "Control Tower" and establishes boundaries and ground rules of engagement.
He or she will lead a cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Main responsibilities include but are not limited to:
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 EM 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 in the Supply Chain to ensure and optimize flow of materials
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 our Company cross-functional team action orientated and time bound improvement plans
Partners with internal External Manufacturing team members including; Procurement, Quality, 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.
Participates 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 Sour of Supply (SOS)/New Product Introduction (NPI) changes at an external party and assume primary ownership of the new relationship.
Ensures there is a plan with clear actions and timelines in place to delivery this SOS or NPI.
Works with the external partner to understand CMO 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
Is 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 agreed upon by our Manufacturing Division and 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), 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.
Acts as our Company Production System (LSS) 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 approved.
Leads with the external partner periodic Business and Operations Review Meetings. Based on our Company and External Manufacturing strategy the External Manufacturing Operations Associate Director develops with their cross functional team and their external partner the annual plan for the relationship with clear goals and targets.
Prepares an annual "state of the union" presentation for the relationships she or he manages which includes successes and failures in order to leverage across External Manufacturing Organization.
Participates in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc.
Qualifications:
Bachelor's degree preferably in the Engineering, Science or Business and a minimum 8 years' experience in commercial /business and manufacturing (sterile operations, quality, technology, planning), roles required with a significant portion in management/leadership positions.
A minimum of eight (8) years' of experience in commercial /business and manufacturing (sterile operations, quality, technology, planning) roles
At least two (2) years of experience in management/leadership positions.
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 Sterile Operations.
Has proven Lean Six Sigma skills to deliver compliant supply and achieve highest quality, lowest cost and shortest lead-time
Has skills to understand and intelligently apply economic, financial and industry data to make business decisions that drive value for our Company and our customers.
Can Visualize the way forward, identifying opportunities that add value to the work and proactively mitigate risk across the value chain
Must possess excellent interpersonal, communication, collaboration and negotiation skills to work outside boundaries as a norm
Ability to use deep knowledge and expertise in production operations to drive results and business outcomes
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 to supply chain optimization
Direct Health Authority Audit experience is desirable
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\EEOC\KnowYourRights\10\20.pdf)
EEOC GINA Supplement?
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)
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.
Expected US salary range:
$126,500.00 - $199,100.00
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 (https://www.benefitsatmerck.com/) .
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
Search Firm Representatives Please Read Carefully
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.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Remote
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
05/1/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R346713
