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Resilience Operations Manager

2 months ago

Holly Springs, United States FUJIFILM Corporation Full time

Position Overview:

As a key player in our organization, the Resilience Operations Manager will spearhead the Resilience team, focusing on the classification, investigation, and resolution of critical incidents. This role is essential in ensuring that we maintain the highest standards of quality and compliance in our operations.

Key Responsibilities:

During Project Phase:

  • Lead and develop a proficient investigations team.
  • Ensure team members are well-versed in investigational and root cause analysis methodologies to prepare for Good Manufacturing Practices (GMP) operations.
  • Facilitate the transition of deviation management processes from affiliated sites while expanding the investigations team.
  • Oversee administrative responsibilities, including timecard and expense report approvals.
  • Execute additional duties as assigned.

In Operational Phase:

  • Manage and mentor a team of investigators, coordinating their tasks effectively.
  • Guarantee timely closure of investigations while upholding rigorous quality standards.
  • Act as the primary liaison for customers regarding investigation management and status updates.
  • Drive continuous improvement initiatives by holding the investigations team accountable for effective Corrective and Preventive Actions (CAPA).
  • Collaborate cross-functionally with other managers to ensure a competent team of auxiliary investigators is trained and ready.
  • Maintain compliance metrics and key performance indicators (KPIs) related to resilience and manufacturing support.
  • Serve as the lead during regulatory inspections and audits.
  • Promote a culture of inclusivity and personal development through regular one-on-one meetings with team members.
  • Complete necessary administrative tasks as required.

Candidate Profile:

The ideal candidate will possess the ability to collaborate effectively across various functional areas, demonstrating strong organizational and project management skills. A commitment to continuous improvement and a solid understanding of manufacturing practices and safety regulations are essential. The candidate should also have experience in coaching and developing team members.

Basic Qualifications:

  • High School diploma or GED with 10 years of experience in life sciences, pharmaceuticals, or regulated industries; or
  • Bachelor's Degree with 6 years of relevant experience; or
  • Master's Degree with 4 years of relevant experience.
  • Proven experience in managing and developing teams.
  • Familiarity with regulatory inspections and change management processes.
  • Experience with various root cause analysis tools.
  • 2-3 years of experience leading investigations or an investigations team.

Preferred Qualifications:

  • 6-10 years of experience in pharmaceutical or biological manufacturing operations.
  • Previous leadership experience in a pharmaceutical or biological manufacturing environment.
  • Experience in a dynamic, project-driven organization.
  • Lean certification or similar qualifications.

Physical Requirements:

  • Ability to discern audible cues.
  • Ability to stand and sit for extended periods.
  • Capability to perform tasks that involve moving objects up to 10 pounds.