Sr. Spclst, External Manufacturing

MSD

18d ago

Job
Full-time
Senior Level
Logistics
Madrid
10d left

AI generated summary

You should have a bachelor's in Engineering/Science, 5+ years in manufacturing, compliance experience, Lean Six Sigma skills, strategic thinking, and strong communication abilities. Expect 25-50% travel.
You will manage External Partner relationships, oversee production execution, ensure compliance, drive continuous improvement, resolve disputes, and support capacity planning and inventory control.

Requirements

Bachelor's degree preferably in Engineering and/or Science
Minimum 5 years’ experience in commercial / business and manufacturing preferred (operations, quality, technology, planning), roles required with a portion in management/leadership positions
Minimum of 3 years of operational experience is manufacturing environment ideally in Active Pharmaceuticals manufacture or equivalent (Food, Chemical, Other), driving Execution Excellence
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 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
Between 25% to 50% travel required for the role when supporting new product introduction. This may include working in shifts and / or working on weekends as per project requirements

Responsibilities

The role is to be a “Virtual Plant Manager” within External Manufacturing. They oversee the companies relationship with the External Partner
The role serves as the air traffic controller of all information/interactions between our company and the External Partner, establishing boundaries and the ground rules of engagement
Is the leader of the Focus Factory Team, 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). Champions diversity, equity, and inclusion programs with their Focus Factory Team and enables participation in events
Based on our company's strategy the role develops the annual relationship priorities with clear goals and targets for the Focus Factory Team and External Partners
Is accountable for all external partner business related activities including:
Ensuring compliance (Quality Risk management, Deviation Management, Product Release, Change Control)
Driving Execution Excellence at our partner sites for effective production planning, materials / resource management & meeting demands / delivering on priorities
Meeting Demand, Production Planning, Materials Management
Dispute resolution (w/ appropriate escalation)
Technology issues
Oversight of shop floor production (determining when an External Manufacturing functional rep should be deployed to the External Partners 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 value chain (operations, quality & compliance, safety, raw materials, resources) and work closely together with Focus Factory team and External Partner to manage and mitigate risks, aiming for zero interruption of the supply chain and ensuring 100% compliance in quality and in environment, health and safety
Is frequently present at their external partners site on the production floor, conducts GEMBA of manufacturing facility for understanding the equipment trains / layouts w.r.t. ease of operations, housekeeping & hygiene; review piping layouts from GEP perspective i.e., having proper slopes, no dead legs etc. & from safety perspective to ensure availability of all required safety installations, earthing & grounding provisions etc
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's cross-functional team action orientated and time bound improvement plans
Partners with External Manufacturing Procurement, Quality and Technology on commercial aspects of relationship, including new External Party Identification, Selection, Negotiation and Re-negotiate/termination
The role 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 External Manufacturing on the cross-functional teams with Supply Chain Management / Product Source Management / Procurement / Product Teams for due diligence ahead of siting approval & post siting approval to support source of supply and new product introduction changes at an external partner and assume primary ownership of the new relationship. The role will ensure there is a plan with clear actions and timelines in place to deliver this source of supply or New Product
The Role works with the external partner to understand our company’s requirements and the External Partners capacity (e.g. stated capacity, firm capacity, future capacity plans, time horizon / lead times required for raw materials, manufacturing & shipping 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 Manufacturing Division and the External Partner are executed including purchase orders, forecasts, deliveries, and approving invoice payments
Is accountable for inventory control. Depending on the location of goods (at External Partner or at our company), the role ensures adequate documentation of material disposition. In some markets, the role may need to witness the destruction of goods (to prevent counterfeiting) or have the External Partner certify the destruction and provide supporting documentation
Supports lean six sigma improvements internally and with External Partners, identifying improvement opportunities and supporting implementation once approved for implementation
Supports with the external partner periodic Business and Operations Review Meetings
The prepares an annual “state of the union” presentation for the relationships they manage which includes successes and lessons learned
Supports strategic initiatives such as New Product Introduction, Network actions, Due Diligence etc
Is active in Person in Plant Activities for cause or to support new product introductions / tech transfer projects
Participates in the creation and maintenance of an External Manufacturing Organization Handbook containing Global External Manufacturing policies, procedures, templates, etc

FAQs

What is the primary role of the Sr. Specialist, External Manufacturing?

The primary role is to oversee the relationship with External Partners, ensuring compliance, supply, continuous improvement, and cost-effectiveness while driving execution excellence and managing cross-functional teams.

What educational background is preferred for this position?

A Bachelor's degree in Engineering and/or Science is preferred.

How many years of experience are required for this position?

A minimum of 5 years of experience in commercial/business and manufacturing roles is required, with at least 3 years in an operational manufacturing environment.

What kinds of manufacturing environments should the candidate have experience in?

Experience in Active Pharmaceuticals manufacture or equivalent industries such as Food or Chemical is ideal.

Is travel required for this position?

Yes, between 25% to 50% travel is required, particularly for supporting new product introductions.

What compliance knowledge is necessary for this role?

The candidate should have a deep understanding of GMP (Good Manufacturing Practices) and EHS (Environmental, Health, and Safety) compliance, as well as experience with quality compliance risk.

What skills are important for strategic thinking in this role?

The ability to visualize the way forward, identify opportunities that add value, and proactively mitigate risks across the value chain is vital.

Will this role involve managing disputes with External Partners?

Yes, the role includes dispute resolution with appropriate escalation when necessary.

How important is the focus on continuous improvement?

Continuous Improvement is a key responsibility, and the candidate should support Lean Six Sigma initiatives both internally and with External Partners.

What types of contracts will the Sr. Specialist be responsible for?

The specialist will maintain the integrity of the Master Supply Agreement and ensure alignment with Supply and Quality agreements, including executing terms related to purchase orders, forecasts, deliveries, and invoice payments.

Is experience with external manufacturing procurement necessary for this role?

Yes, the role involves partnering with External Manufacturing Procurement on commercial aspects of the relationship, including new External Party identification and negotiation processes.

What is a Focus Factory Team?

A Focus Factory Team is a cross-functional group responsible for delivering the daily, weekly, monthly, and annual requirements at the external partner's site, and the Sr. Specialist is the leader of this team.

Are there specific software or tools that the candidate should be familiar with?

While specific tools are not mentioned, familiarity with risk assessment, compliance management, and operational excellence frameworks would be beneficial.

Will the candidate need to be present at external partner sites frequently?

Yes, the role requires frequent presence at external partner sites to conduct assessments and support manufacturing activities.

MSD

We aspire to be the premier research-intensive biopharmaceutical company.

Science & Healthcare

Industry

10,001+

Employees

1891

Founded Year

Mission & Purpose

MSD, also known as Merck & Co. Inc. in the United States and Canada, is a global pharmaceutical company that focuses on discovering, developing, and delivering innovative healthcare solutions. They research and develop a wide range of prescription medicines, vaccines, biologic therapies, and animal health products. MSD's ultimate mission is to improve and save lives by addressing unmet medical needs and advancing healthcare worldwide. Their purpose is to develop innovative medicines and therapies that tackle diseases and conditions affecting individuals across the globe, with a strong emphasis on scientific excellence, patient-centricity, and ethical business practices. MSD strives to make a meaningful impact on public health by providing access to safe, effective, and high-quality healthcare solutions, while also contributing to the broader advancement of medical knowledge and healthcare systems

Culture & Values

Patients first
We are all accountable for delivering high quality products and services. We aspire to improve the health and wellness of people and animals worldwide, and to expand access to our medicines and vaccines. All of our actions must be measured against our responsibility to those who use or need our products.
Respect for people
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, safety and teamwork of our employees. We work to create an environment of mutual respect, inclusion and accountability. We reward commitment and performance and are responsive to the needs of our employees and their families.
Ethics and integrity
We are committed to the highest standards of ethics and integrity. We are responsible to all of our stakeholders: employees, patients, customers, distributors and suppliers, shareholders, and the communities we serve worldwide. We do not take professional or ethical shortcuts.
Innovation and scientific excellence
We are dedicated to the highest standard of innovation and scientific excellence. Our research is guided by a commitment to improving health and quality of life. We strive to identify and meet the most critical needs of patients and customers through continuous innovation across all areas of our business.