Job Description
Are you ready to make a meaningful impact and drive innovation in the healthcare industry? The Global Pharmaceutical Organization (GPO) at our company is excited to invite passionate individuals to join our dynamic team!
GPO is a diverse global organization committed to bringing a compliant, reliable supply of life-saving and affordable medicines to patients around the world. Our organization is responsible for the manufacturing and supply of all pharmaceutical products, packaging of the entire Human Health portfolio and commercialization of the small molecule new product pipeline. GPO manages a wide range of products serving communities in more than 175 markets around the globe with more than 7 billion doses of vital medicine distributed each year. Collaborating with other operating units and functions, GPO's commitment to enhancing the patient experience and improving access to life-saving treatments is achieved through a network of internal and external sites that support the enterprise and division strategic priorities.
The External Manufacturing Operations Senior Specialist (ExMOSrS) is accountable for meeting customer demand at the External Partner (EP) they support by achieving excellence in Compliance, Supply, Continuous Improvement & Cost through their leadership and coaching of our company's responsible cross-functional teams and their work in partnership with those EP's while leveraging our company's Production System principles (MPS) and the E2E supply chain.
The ExMOSrS serves as a point of contact for dealings between our manufacturing division and the EP and supports a strong business partnership as well as boundaries and ground rules of engagement.
Primary Activities:
ExMOSrS is Virtual Plant Management support within ExM. They support our manufacturing division's relationship with the external partner.
Leads / supports our manufacturing division cross-functional team (Supply Chain, Quality, Technical Ops, Procurement...) who are responsible for delivering daily/weekly/monthly/annual requirements at their external partner(s).
Work with VCM (Value Chain Management) Lead and team (where applicable) and Product Technical Steward (where applicable) to support the designated products.
Is accountable for operational related activities such as
Ensuring 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 funcional 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
Builds a strong interdependent relationship with the site's leadership team and can ("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's cross-functional team action orientated and time bound improvement plans
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 ExMOSrS may not be involved in all transactional interactions if they can be managed/delegated to a functional area but will be kept appraised of status/resolutions, etc.
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 ExMOSrS will ensure there is a plan with clear actions and timelines in place to deliver this SOS or NPI.
The ExMOSrS 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 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), ExMOSrS 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.
Supports our company's Production System improvements internally and with EPs.
Supports the external partner periodic Business and Operations Review Meetings. Based on our company and ExM's strategy the ExMOSrS develops with their cross functional team and their external partner the annual Priorities for the relationship with clear goals and targets. The ExMOSrS also supports EP / company presentations for the relationships they manage.
Supports strategic initiatives of network actions to enable World Class Supply.
Participates in the maintenance of an External Manufacturing Organization information containing Global ExM policies, procedures, templates, etc.
Minimum Education Requirements:
Bachelor of Science (BS) degree in Engineering, Science, Business or related field with four (4) years' experience in commercial/business and pharmaceutical manufacturing (operations, quality, technology, planning), roles required with experience with leadership opportunities. OR
Master of Science (MS) degree in Engineering, Science, Business or related field with two (2) years' experience in commercial/business and pharmaceutical manufacturing (operations, quality, technology, planning), roles required with experience with leadership opportunities.
Required Experience and Skills:
Work Environment - Adaptability to work in remote setting with remote teams.
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. Direct Health Authority Audit experience desirable.
World Class Supplier Mindset - Has experience with 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
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 salary range for this role is
$104,200.00 - $163,900.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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:
Hybrid
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Required Skills:
Adaptability, Adaptability, Biopharmaceutical Manufacturing, Business, cGMP Regulations, Clinical Supply Chain Management, Communication, Contract Management, Contract Manufacturing, Driving Continuous Improvement, External Manufacturing, Financial Advising, GMP Compliance, Inventory Control Procedures, Lean Six Sigma (LSS), Lean Six Sigma Continuous Improvement, Management Process, Manufacturing Operations, Manufacturing Operations Management (MOM), Process Optimization, Procurement, Production Operations, Production Planning, Production Scheduling, Product Lifecycle {+ 7 more}
Preferred Skills:
Job Posting End Date:
09/12/2025
*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: R364155
