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Project Manager, Regulatory Compliance Specialist, Operations Management

Job in Horsham, Montgomery County, Pennsylvania, 19044, USA
Listing for: Kelly
Full Time position
Listed on 2026-08-22
Job specializations:
  • Business
    Regulatory Compliance Specialist, Operations Management
Salary/Wage Range or Industry Benchmark: 90000 - 120000 USD Yearly USD 90000.00 120000.00 YEAR
Job Description & How to Apply Below

We are seeking a CAR‑T Project Manager to support the expansion and activation of authorized CAR‑T treatment centers nationwide. This role partners closely with field-based activation leads and cross‑functional stakeholders to manage end‑to‑end site certification activities, track key performance indicators, and drive continuous process improvement.

The ideal candidate brings strong project management expertise within healthcare or life sciences and thrives in a fast‑paced, highly regulated environment focused on delivering an exceptional customer and patient experience.

Key Responsibilities Site Certification Management
  • Oversee end‑to‑end project management for the activation and certification of new CAR‑T treatment sites.
  • Support field-based activation teams by tracking deliverables, milestones, and regulatory requirements.
  • Ensure alignment with internal standards and external compliance expectations throughout the certification process.
Stakeholder Collaboration
  • Partner cross‑functionally with clinical, regulatory, operations, quality, and technical teams to facilitate efficient and customer‑focused site activation.
  • Act as a central point of coordination to ensure timely communication and issue resolution.
Timeline & Resource Management
  • Develop and maintain detailed project plans, timelines, and resource tracking to support timely, high‑quality activation outcomes.
  • Monitor progress against plans and proactively adjust priorities as needed.
Risk Identification & Mitigation
  • Identify risks and constraints within the site certification process.
  • Develop and implement mitigation strategies to minimize delays or operational impact.
Documentation & Reporting
  • Maintain comprehensive documentation of certification activities, milestones, and outcomes.
  • Track, analyze, and report KPIs related to site activation progress and operational performance.
  • Prepare clear, concise updates for leadership and key stakeholders.
  • Evaluate existing workflows and identify opportunities to streamline processes and improve efficiency.
  • Lead or support continuous improvement initiatives to enhance the site certification experience for internal and external partners.
Training & Support
  • Provide guidance and tools to site teams and field partners to support successful certification.
  • Help ensure stakeholders understand requirements, timelines, and expectations.
Qualifications
  • 3-5 years of project management experience, preferably in healthcare, biotechnology, or pharmaceuticals
  • 3-5 years of experience within life sciences or a regulated industry
  • Working knowledge of CAR‑T therapies, oncology (including multiple myeloma), and healthcare regulations preferred
  • Proven ability to manage complex, cross‑functional initiatives with multiple stakeholders
  • Strong organizational, communication, and leadership skills
  • Ability to prioritize effectively in a dynamic, fast‑moving environment
  • PMP or other project management certification is a plus
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