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Job Description: The COQA Quality Manager is accountable for establishing relationships with primary packaging component suppliers to Pharmaceutical Manufacturing sites worldwide. This role on the Supplier Quality Management team partners with internal customers and external suppliers to reduce Total Cost of Quality ownership. Leverage Lean Six Sigma DMAIC methods and Production Part Approval Process elements with suppliers for the sake of continuous quality improvement and effective issue resolution.
This is an independent position operating with moderate supervision, interacting with high levels of management both at suppliers and within Pharmaceutical PGS. Will operate as spokesperson for COQA Supplier Quality Management and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Pharmaceutical quality requirements with component suppliers.
• Drive measurable quality performance improvements applying DMAIC methodologies across the key component suppliers to improve Pharmaceutical's fundamental value proposition with customers, regulators and investors.
• Provide Quality Leadership and establish credibility across Pharmaceutical manufacturing, procurement and technical organizations in order to facilitate rapid resolution to material issues encountered.
• Lead activities associated with the qualification and onboarding of new suppliers integrating the Production Part Approval Process, including tech transfers and supplier material changes.
• Partner with procurement on supplier strategy to help develop a robust supply chain with the lowest total cost of ownership and world class quality performance.
• Minimally BA/BS Engineering, Packaging, or related technical discipline
• Minimally 8 years in a GXP setting
• At least 4 years in Product Quality Assurance
• Black Belt Certification/ PPAP Expertise preferred
• Experience with external suppliers/contractors is preferred
• Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, Documentum platforms and statistical tools (Minitab)
• Command of English language required and multi-lingual is beneficial.
• Strong verbal and written communication including presentation skills
• Up to 25% travel required
• Demonstrated personal leadership to manage multiple projects
• Is diplomatic in communication with internal and external customers
• Supervisory experience desirable
Application of Knowledge and Skills
Has extensive knowledge of the principles, concepts and theories of the discipline, and working knowledge of principles and concepts of other disciplines
Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within discipline
Applies knowledge of internal/external business challenges to provide input into recommendations for improvements to products, processes or services
Begins to create an environment that supports experimentation beyond self. Takes appropriate risks to advance new concepts and methodologies that are moderately complex
Makes decisions that may require developing new options to resolve complex problems
Makes decisions guided by policies in non-standard situations
Operates independently in ambiguous situations within department; decisions may directly affect department ability to deliver its objectives
Decisions impact work group/project team or department and its customers; decisions affect program/project delivery and may impact expenditure on existing/alternative resources
Exercises judgment utilizing breadth of knowledge and prior work experience. May become a resource for others
Works independently. Receives instruction primarily on unusual or complex problems. May independently develop approach to solutions
Exercises considerable latitude in determining objectives of assignments
Generally reviews own work. Solicits directional review from others. May review work completed by other colleagues when acting in mentor role
Provides guidance to and/or may lead/co-lead projects
Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects
Develops constructive relationships across disciplines and function. Represents work group/project team or department on cross-line teams
Regularly takes informal leadership role during team meetings to facilitate agreements and move the team toward its goals. Takes responsibility for a portion of the team's milestones/deliverables. May lead (virtual) operational team(s)
• Functional / Technical Skills
• Acts Decisively
• Seizes Accountability
• Grows Self
• Change Agile
• Self Awareness
• Commits to "One Pharmaceutical”
• Peer Relationships
• Deal with Ambiguity
• Decision Quality
• Customer Focus
• Conflict Management
• Standing Alone
• Project Management
• Committed to the Needs of our Customers (Customer Focus)
• Give Back to the Community (Community)
• Treat Others with Dignity and Respect (Respect for People)
• Think Strategically and Execute Flawlessly (Performance)
• Demand / Demonstrate Teamwork (Collaboration)
• Ability to Engage Teams (Leadership)
• Be a Role Model (Integrity)
• Right First Time (Quality)
• Think Broadly (Innovation)
Position Comments visible to MSP and Supplier: Manager is looking for 10-15 years experience. Please do not send entry level candidates
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