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Job Description
The External Manufacturing Operations Director (Ops Director) provides leadership in the areas of:
Building relationships with our external partners
Dispute resolution (w/ 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
Lead 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/leadershippositions
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 Europe. No relocation required
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
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.
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