Director, Integrated Process Team (IPT) Leader

MSD•Wilson, NC
•$173,200 - $272,600•Onsite

About The Position

The Director, Operations position serves as the business unit manager for the cross-functional integrated process team (IPT) supporting a business area. This role provides leadership to the IPT and will also represent the business area on the Wilson Site Leadership Team. Primary responsibilities for this position include providing tactical and strategic direction to the IPT. This includes ensuring that business objectives are met, a high standard for Quality and EHS compliance is maintained, and the IPT operates efficiently and within budget. The position will also be expected to promote continuous improvement within the IPT (aligned with lean manufacturing principles) and maintain an inclusive culture that supports positive employee relations. Additional activities, responsibilities, and competencies include but are not limited to the following: Compliance: Ensure that operations are executed in compliance with Safety, Environmental, Quality (cGMP), and Labor regulations. Demonstrate leadership by maintaining a safe workplace and managing actions to prevent safety incidents. Investigate, determine root cause, and implement robust CAPAs for any compliance discrepancies noted during activities, trend reviews, internal audits, or inspections. Delivery: Utilize a high degree of independent judgment and decision-making to direct production, packaging, and support personnel to ensure customer supply requirements are achieved. Resolve and escalate issues impacting supply within the daily, weekly, and monthly IPT and site management processes. Cost: Develop budget for the IPT and ensure that activities are carried out in accordance with budget forecast. Identify and execute capital projects needed to support the IPT short and long-term strategies. Recognize and implement opportunities for efficiency and financial savings including elimination of waste. People and Team: Define and staff positions necessary to execute multi-shift operations at the Wilson site. Provide leadership to the cross-functional team and direct Operations team providing coaching, development, and performance management where appropriate. Ensure culture of inclusion and consistency is maintained supporting positive employee relations within the team and site. Build effective relationships with other functional areas as well as stakeholders across our Company network. Strategic Support and Continuous Improvement: Help develop the strategy for the IPT as well as tactical plans to meet those goals. Embed a culture of continuous improvement and MPS into the Operations team focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving. Identify and implement opportunities for process optimization and efficiency. Provide site support and leadership to high-priority network strategies and initiatives.

Requirements

  • B.A./ B.S. degree (preferably in Science or Engineering related field), Master’s Degree preferred
  • Minimum 12 years relevant industry experience across multiple functions (Operations, Quality, Technical, Engineering, Supply Chain Management, etc.)
  • Concurrently, minimum 5 years Operations experience with some responsibility managing multi-layered organizations.
  • Strong leadership and influencing skills: ability to drive change, influence stakeholders, and motivate teams to achieve stretch goals.
  • Working knowledge of cGMP and regulatory requirements as they apply to the pharmaceutical industry
  • Strong communication skills: ability to effectively communicate with cross-functional teams, above-site stakeholders, and external authorities.
  • Willing to work irregular hours to support multi-shift operation on an as needed basis
  • DP Operations
  • Leadership
  • Lean Manufacturing
  • Packaging
  • People Leadership
  • Plant Operations
  • Process Optimization
  • Production Scheduling
  • Safety Compliance
  • Sterile Manufacturing
  • Strategic Planning
  • Team Collaboration
  • Team Strategy

Nice To Haves

  • Experience leading a complex manufacturing or packaging operation within a plant site (Operations, Quality, or Technical role)
  • Experience licensing a new facility or start-up/scale-up of new capital installations for commercial supply
  • Experience in continuous improvement, lean manufacturing, problem solving, and/or right first time methodologies
  • Familiarity with change execution management and behavioral coaching / consequence management tools
  • Strong written and verbal communication including presentation skills and technical writing experience (investigations, change requests, standard operating procedures, protocols, etc.)
  • Project management skills: ability to prioritize tasks, manage timelines, and meet deadlines.
  • Experience supporting regulatory inspections (FDA, EMA, etc.)

Responsibilities

  • Provide tactical and strategic direction to the IPT.
  • Ensure business objectives are met.
  • Maintain a high standard for Quality and EHS compliance.
  • Ensure the IPT operates efficiently and within budget.
  • Promote continuous improvement within the IPT (aligned with lean manufacturing principles).
  • Maintain an inclusive culture that supports positive employee relations.
  • Ensure operations are executed in compliance with Safety, Environmental, Quality (cGMP), and Labor regulations.
  • Demonstrate leadership by maintaining a safe workplace and managing actions to prevent safety incidents.
  • Investigate, determine root cause, and implement robust CAPAs for any compliance discrepancies.
  • Direct production, packaging, and support personnel to ensure customer supply requirements are achieved.
  • Resolve and escalate issues impacting supply within the daily, weekly, and monthly IPT and site management processes.
  • Develop budget for the IPT and ensure activities are carried out in accordance with budget forecast.
  • Identify and execute capital projects needed to support the IPT short and long-term strategies.
  • Recognize and implement opportunities for efficiency and financial savings including elimination of waste.
  • Define and staff positions necessary to execute multi-shift operations at the Wilson site.
  • Provide leadership to the cross-functional team and direct Operations team providing coaching, development, and performance management.
  • Build effective relationships with other functional areas as well as stakeholders across our Company network.
  • Help develop the strategy for the IPT as well as tactical plans to meet those goals.
  • Embed a culture of continuous improvement and MPS into the Operations team focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving.
  • Identify and implement opportunities for process optimization and efficiency.
  • Provide site support and leadership to high-priority network strategies and initiatives.

Benefits

  • medical, dental, vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
  • annual bonus
  • long-term incentive
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