Lilly
healthcare
AssociateDirectorJointProcessTeamLead
“Associate Director - Joint Process Team Lead at Lilly. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, Quality and Supply Plans, Technical Agenda, cGMP compliance, contracts, Quality Agreement. Lead cross-functional Joint Process Team (JPT), between Lilly and contract manufacturer (CM), to develop and implement strategically aligned Quality and Supply Plans as well as the Technical Agenda fo”
What You'll Achieve.
Accountable for the metrics that align with Global Contract Manufacturing Standards (GCMS) to monitor performance at the CMs, and to review these at API external manufacturing lead team meetings.; Accountable for on time delivery of commitments to supply plan, quality plan, and technical agenda.
Industry & Context.
Resolve supply chain issues; Manage conflict and problem resolution.
Travel will be required (~ 20%)
What They're Looking For.
Must Have
Bachelor’s degree or equivalent in Chemical Engineering, Mechanical Engineering, Chemistryiochemistry or related science., 5+ years of experience in pharmaceutical manufacturing, technical support, quality assurance, and/or quality engineering.
Nice to Have
Ability to represent Eli Lilly and Company in a positive, professional, and ethical manner to both internal (Affiliate) and third-party contract manufacturers., leadership and interpersonal skills, ability to build effective relationships, influence and achieve results through people., Self-motivated with ability to react quickly to changing requirements and processes., Demonstrated experience aligning with, delivery of or assuring cGMP compliance of a production operation., Proficiency in Word/Excel/PowerPoint and knowledge of Lilly-based systems (i. e. , Trackwise, SAP, Veeva Vault), Project management skills including the ability to lead teams to produce quality deliverables within established time frames., Proficiency in Microsoft Project., Experience with contracts and relationships with third party suppliers., Establish technical, quality, and business networks.
What You'll Do.
Lead cross-functional Joint Process Team (JPT)
between Lilly and contract manufacturer (CM)
to develop and implement strategically aligned Quality and Supply Plans as well as the Technical Agenda for the CM.
Successfully facilitate and champion quality
and regulatory compliance to ensure continuous supply to the marketplace.
batch release and shipment schedules to ensure appropriate resources to meet objectives.
Resolve supply chain issues and provide internal notification to management or joint Lilly/CM Steering Team as necessary.
Author Manufacturing Responsibilities Document (MRD) defining each party’s roles and responsibilities aligned with the contract and Quality Agreement.
Ensure that the MRD and contracts are being adhered to by Lilly and the CM.
Make regular visits to CM to increase awareness of operations and maintain a working relationship.
Manage conflict and problem resolution.
Facilitate Lilly/CM Steering Team meeting agendas with issues from the JPT meetings requiring Steering Team action.
Present and document the decisions in Steering Team minutes.
Meet regularly with customers (Lilly plant sites or Lilly affiliates) to ensure supply goals are met
review performance metrics and improve customer service.
Evaluate and manage efficiencies with product supply chains.
Work with Tech Service/QC/Engineering/QA Representatives and 6 Sigma on continuous improvement projects.
Deliver all product / projects to comply with GQS
and applicable internal SOP’s.
Assisting Tech Service and QA personnel to ensure timely completion of APR
How You'll Work.
Team & Collaboration
Lead cross-functional Joint Process Team (JPT), between Lilly and contract manufacturer (CM).; Serve as liaison to communicate status and issues to various management levels in operations, quality, marketing, and manufacturing networks.; Facilitate Lilly/CM Steering Team meeting agendas with issues from the JPT meetings requiring Steering Team action.; Meet regularly with customers (Lilly plant sites or Lilly affiliates) to ensure supply goals are met, review performance metrics and improve customer service.; Work with Tech Service/QC/Engineering/QA Representatives and 6 Sigma on continuous improvement projects.
Communication Scope
Serve as liaison to communicate status and issues to various management levels in operations, quality, marketing, and manufacturing networks.
Process & Methodology
Project management skills including the ability to lead teams to produce quality deliverables within established time frames., Proficiency in Microsoft Project.
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