Merck
Director, External Manufacturing Operations
Merck, Durham, North Carolina, United States, 27701
External Manufacturing Operations Director
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 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 (Ops Director) provides leadership in the areas of: Building relationships with our external partners Dispute resolution (with appropriate escalation) Strategic Production Planning Materials Management (Systems Applications and Products (SAP), End to End Planning, Logistics) Quality issues (Deviation Management, Product Release, Change Control) Technology issues (Technology transfers, Investigations, Process Improvements, etc.) Oversight of shop floor production and determining when an External Manufacturing Quality or Technology representative should be deployed to the External Party's facility Production System (MPS) and Continuous Improvement activities The responsibilities of the Operations Director include, but are not limited to: Partnering with the External Manufacturing leaders in the functional areas (e.g., Procurement, Quality, Technology, Finance, Legal, HR, etc.) to address broader business issues, customer needs and opportunities Leading a cross-functional team with focus factory responsibility to ensure our products are manufactured, tested and dispositioned safely and compliant to cGMPs Participating in the annual profit planning process, provides a monthly estimated actual on the organization's projected and actual spending and maintains a multi-year capital plan/budget Creating and maintaining a high-performance team organization and culture Ensuring External Party capacity information (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) is provided for robust end-to-end planning activities Facilitating External Manufacturing Operations collaboration to leverage best practices & lessons learned across External Manufacturing Ops Participating in periodic Joint Steering Committee and Relationship Review Meetings (as appropriate) Contributing as a member of the applicable Value Chain Management Teams, as appropriate, charged with reducing overall cycle time, inventory, and supporting life cycle management activities Participating on the applicable Biologics Business Leadership Teams representing External Manufacturing Org and his/her respective external party relationships The Ops Director stays abreast with industry and policy changes and identifies implications and opportunities for their area of External Manufacturing and/or External Manufacturing Organization at large. Education Minimum Requirement: Bachelor's degree (a degree in Engineering, Science or Business is preferred) MBA preferred Required Experience and Skills: A minimum ten (10) years' experience in commercial/business and/or manufacturing (in the following areas: operations, quality, technology, planning, procurement) function required (or equivalent of education/experience for PhDs) At least two (2) years of experience in management/leadership positions At least two (2) years of experience working in operations, technology or quality manufacturing Antibody-drug conjugate (ADC) compounds Must possess excellent interpersonal, communication, collaboration, negotiation, and project management skills Has demonstrated strong leadership, managerial, problem solving, and team building abilities and sensitivity to diverse cultures in current or past positions, which may include Employee Business Resource Group (EBRG) leadership experience such as Women's Network, LEAD or mentoring Must possess the ability to work independently Must be decisive in ambiguous environment Able to be the one face of our Company to the external party Has experience and ability to achieve compliance goals, through a risk-based approach with a deep understanding of cGMPs 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 Ability to apply understanding of end-to-end supply chain within external and internal networks and stakeholders across the network to achieve results and contribute to supply chain optimization Direct Health Authority Audit experience is desirable The role can be based at selective company sites across the United States and Europe. No relocation required. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. 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 (Ops Director) provides leadership in the areas of: Building relationships with our external partners Dispute resolution (with appropriate escalation) Strategic Production Planning Materials Management (Systems Applications and Products (SAP), End to End Planning, Logistics) Quality issues (Deviation Management, Product Release, Change Control) Technology issues (Technology transfers, Investigations, Process Improvements, etc.) Oversight of shop floor production and determining when an External Manufacturing Quality or Technology representative should be deployed to the External Party's facility Production System (MPS) and Continuous Improvement activities The responsibilities of the Operations Director include, but are not limited to: Partnering with the External Manufacturing leaders in the functional areas (e.g., Procurement, Quality, Technology, Finance, Legal, HR, etc.) to address broader business issues, customer needs and opportunities Leading a cross-functional team with focus factory responsibility to ensure our products are manufactured, tested and dispositioned safely and compliant to cGMPs Participating in the annual profit planning process, provides a monthly estimated actual on the organization's projected and actual spending and maintains a multi-year capital plan/budget Creating and maintaining a high-performance team organization and culture Ensuring External Party capacity information (e.g., stated capacity, firm capacity, future capacity plans, time horizon / lead times required, etc.) is provided for robust end-to-end planning activities Facilitating External Manufacturing Operations collaboration to leverage best practices & lessons learned across External Manufacturing Ops Participating in periodic Joint Steering Committee and Relationship Review Meetings (as appropriate) Contributing as a member of the applicable Value Chain Management Teams, as appropriate, charged with reducing overall cycle time, inventory, and supporting life cycle management activities Participating on the applicable Biologics Business Leadership Teams representing External Manufacturing Org and his/her respective external party relationships The Ops Director stays abreast with industry and policy changes and identifies implications and opportunities for their area of External Manufacturing and/or External Manufacturing Organization at large. Education Minimum Requirement: Bachelor's degree (a degree in Engineering, Science or Business is preferred) MBA preferred Required Experience and Skills: A minimum ten (10) years' experience in commercial/business and/or manufacturing (in the following areas: operations, quality, technology, planning, procurement) function required (or equivalent of education/experience for PhDs) At least two (2) years of experience in management/leadership positions At least two (2) years of experience working in operations, technology or quality manufacturing Antibody-drug conjugate (ADC) compounds Must possess excellent interpersonal, communication, collaboration, negotiation, and project management skills Has demonstrated strong leadership, managerial, problem solving, and team building abilities and sensitivity to diverse cultures in current or past positions, which may include Employee Business Resource Group (EBRG) leadership experience such as Women's Network, LEAD or mentoring Must possess the ability to work independently Must be decisive in ambiguous environment Able to be the one face of our Company to the external party Has experience and ability to achieve compliance goals, through a risk-based approach with a deep understanding of cGMPs 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 Ability to apply understanding of end-to-end supply chain within external and internal networks and stakeholders across the network to achieve results and contribute to supply chain optimization Direct Health Authority Audit experience is desirable The role can be based at selective company sites across the United States and Europe. No relocation required. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.