Associate Director, External Manufacturing Operations - Medical Devices

Job Requirements

This posting has been created to pipeline talent for prospective roles that we anticipate will be needed soon in our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.

Position Overview

Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director). This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our relationship with External Partners that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical, Biologic, and Vaccine Products.

Our team works with a "Safety First, Quality Always" mindset. As the primary point of contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong business partnership and ensuring excellence in Compliance, Supply, Continuous Improvement, and Cost Management.

The Associate Director, External Manufacturing Operations will also assist in commercialization activities for New Product Introductions that require complex devices and other novel technologies. This role will help build and maintain strong collaboration with a wide range of professional disciplines in Research, Manufacturing, and Commercial Operations - as we continue to drive growth in this area of our business.

Primary Responsibilities and Activities include but are not limited to

• Lead an Integrated Cross-Functional Team in Delivery of Reliable and Compliant Supply :
• Build a strong interdependent relationship with External Partner Site and Plant Leadership Team.
• Create and maintain an inclusive culture and high-performing team (coaching team members as required).
• Ensure "Right First Time" mindset. Consistently deliver On-Time and In-Full - with First Pass Quality.
• Oversight and presence on the production floor at External Partner site(s).
• Maintain adherence to terms in the Supply Agreement and Quality Agreement - ensuring alignment with the Master Supply Agreement (MSA).
• Dispute and Issue Resolution (with appropriate escalation as required).
• Resolve Technical Issues (Investigations, CAPAs, Process Improvements, Source Changes, Technical Transfers, Equipment Maintenance, Reliability, and Lifecycle Management).
• Lead Periodic Business and Operations Review Meetings (with External Partner).

Compliance : Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance, Risk Management, Deviation Management, Product Release, Change Control).

Supply Chain Management : Manage coordination with End-to-End Product Supply Chain nodes (upstream and downstream) to ensure timely and optimized flow of materials. Demand Management, E2E Production Planning, Materials Management, Logistics, and SAP Entries as needed.

Continuous Improvement : Assess current condition and risks at External Partner site (using appropriate tools and resources). Establish baseline KPI and trends as leading indicators of supplier performance at launch and throughout product lifecycle. Formulate actionable and time bound improvement plans.

Financial Stewardship : Manage Budget, Estimated Actuals, and Accruals for projected spend (Expense, Capital / Prepaid, and Product Cost as required). Provide input into annual ExM Operations Profit Planning process.

Commercialization of New Products : Support of sourcing and siting activities, evaluation of supplier capabilities, participation in on-site due diligence visits, help determine equipment / facility investment requirements, and provide Operations input into Supply and Quality Agreements.

Launch Supply Risk Mitigation : Ensure External Partner Site Readiness, Assist with Technology Transfer, Develop and Execute Manufacturing Process Robustness Plans, Production Oversight.

Minimum Education Requirement

REQUIRED Experience and Skills

No less than eight (8) years of experience in Biopharmaceutical industry across multiple manufacturing disciplines (Operations, Quality, Technology, Engineering, Supply Chain, etc.). At least five (5) years leading teams and / or projects. At least three (3) years in direct management of shop floor production activities.

Project Management - Proficient with Project Management and Virtual Collaboration Tools (Microsoft Project, OneNote, Teams, SharePoint, Action Trackers, Risk Trackers, Decision Logs, etc.).

Communication - Excellent communication and presentation skills (written and verbal). Ability to effectively influence key stakeholder groups (including senior and executive levels of an organization).

Integrity - Stewardship of Company Intellectual Property. Ability to assess appropriate level of information disclosure and maintain confidentiality when dealing with multiple internal and external stakeholders.

Supplier Relationship Management - Ability to manage supplier relationships across a spectrum of strategic priorities and influence.

Business & Financial Acumen - Ability to forecast and manage operating budgets (Expense, Capital / Prepaid, and Product Cost). Understanding of industry and economic data to make business decisions that drive value for our Company and our customers.

Compliance - Deep understanding of Good Manufacturing Practices (GMP) and Environment & Safety Regulations.

Deep Manufacturing Knowledge - Proven expertise in various manufacturing processes, equipment, labor relations, and production best practices.

World Class Supplier Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality, lowest cost, and shortest lead-time.

Strategic Thinking - Ability to identify opportunities that add value to the work - proactively mitigating risk across the value chain.

Working Across Boundaries - Excellent interpersonal and networking skills. Demonstrated ability to build relationships and collaborate with internal and external partners as the normal way of working.

Drive Results and Business Outcomes - Ability to use deep knowledge and expertise in Manufacturing, Technical, and Quality 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) to achieve results and optimize supply chain.

International Experience - Ability to effectively engage and collaborate with diverse cultures across the globe.

PREFERRED Experience and Skills

Manufacturing - Injection Molding and Automated Assembly of Medical Device Components. Final Assembly and Packaging of Combination Products. Experience with OEB 4 / OEB 5 compounds is a plus.

New Product Introductions - Knowledge of Pharmaceutical product development and commercialization. Awareness of MDCP development and commercialization is a plus.

Process Improvement - Knowledge of lean principles, equipment design, and preventative maintenance.

Regulatory - Global regulations and compliance requirements governing development and manufacturing for MDCP (21 CFR Part 4, Medical Device Reporting, ISO 13485 : 2016, EU Medical Device Regulation, etc.).

Strategic Sourcing and Contract Negotiation

Requisition ID : P-100912