As the Director, External Supply Operations, you are responsible for operational execution of external manufacturing and related supply activities. This is a central role within External Supply Operations and requires the ability to manage multiple activities simultaneously, balancing priorities, with a strong sense of urgency, ability to work with ambiguity, and attention to detail. This position will have you collaborating with other members of Supply Chain, Quality Assurance, Regulatory Affairs, and Finance to execute and deliver endorsed global supply plans for both clinical and commercial supply. You will report to the Sr. Director, External Supply Operations.

Responsibilities

• Build and maintain productive relationships with external contract manufacturers (CMO’s), and internal global colleagues.
• Ensure timely and effective execution of all supply plans at assigned CMO’s.
• Develop and manage production processes to support operational execution, including BOM’s, specifications, CAPA’s, change controls, master data, and artwork.
• Support logistics, transportation and import/export activities
• Lead all aspects of Supply Execution with assigned CMOs, including but not limited to, Oversight of Supply Planning and Scheduling, Capacity Management, Purchase Order/Invoice Management, Materials Management and Supply Performance escalation.
• Act as supply chain representative for review and approval of documentation including but not limited to batch records, BOM’s, specifications, artwork, and change controls.
• Support product qualification activities including but not limited to reviewing/approving IQ/OQ/PQs, stability, and validation protocols; review and approve change controls
• Develop and execute manufacturing strategies for product launches; play a key role in supporting technical transfers, operationalizing product supply and site establishment.
• Collaborate with the Supply Planning team via the Sales & Operations Planning Cycle (S&OP) and outsourced manufacturers to ensure supply plan is executed and inventory objectives are met.
• Manage and track inventory, perform inventory reconciliations, and support month end close process.
• Issue purchase orders, and track invoices and budgets
• Maintain production schedules, and track batch record execution in coordination with Quality.
• Proactively Support negotiation of price tiers and terms across multiple sources of supply while maintaining or improving quality and service
• Oversee a continuous performance assessment and utilization of KPIs of contract manufacturing partners regarding pricing, compliance, service, quality, capacity, and management
• Oversee, review, and approve as necessary revisions to manufacturing cGMP and non GMP documentation.
• Where necessary, provide input to manufacturer and QA for evaluation of process deviations and assist in the investigation of product complaints
• Support the design, implementation, and monitoring of supply risk mitigation strategies.
• Build and maintain strong partnerships and provide effective communications with all internal and external stakeholders and lead discussion, problem solving efforts and process improvements to ensure that performance targets are met or exceeded.
• Responsible for scheduling and maintaining routine business operations meetings with CMO’s.

Qualifications

• BS/BA Degree in Life Science, Biology, or Engineering discipline from an accredited college or university, or equivalent desired
• 15+ years combined experience in manufacturing, outsourced operations, technical operations and/or supply chain in regulated healthcare industry, preferably within biotech/pharmaceutical industry.
• Technical background with knowledge of engineering and pharmaceutical manufacturing processes desired
• The ability to function in a fast-paced, high-growth, entrepreneurial environment
• Ability to travel domestically and internationally ~15%
• Position requires a strong working knowledge and understanding of regulations by government agencies affecting the pharmaceutical industry (CFR’s)
• Timely and effective communication across multiple audiences, both verbally and in writing