Change Control Compliance Specialist

4 days ago


Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time

Iovance Biotherapeutics Inc. is seeking a highly motivated Change Control Compliance Specialist to join our team in Philadelphia, PA. This role offers a unique opportunity to leverage your expertise in quality assurance, change control, and compliance to drive business success.

About the Position

This position requires a strong understanding of current Good Manufacturing Practices (cGMP) regulations and guidelines governing pharmaceuticals and biotechnology industry. The ideal candidate will have substantial experience in managing quality systems, conducting investigations, and implementing corrective actions. Responsibilities include administering electronic Quality Management Systems (eQMS), managing change control, deviation, and CAPA processes, training users, and facilitating cross-functional meetings.

  • Develop and implement quality systems: Collaborate with cross-functional teams to develop and implement effective quality systems that ensure compliance with regulatory requirements.
  • Conduct investigations and implement corrective actions: Conduct thorough investigations into deviations and CAPAs, identifying root causes and implementing corrective actions.
  • Provide training and support: Deliver comprehensive training sessions to ensure users are proficient in utilizing eQMS effectively and efficiently.
  • Facilitate cross-functional meetings: Attend meetings as needed to provide quality systems expertise and ensure alignment among teams.
Key Responsibilities

The Change Control Compliance Specialist will be responsible for the following tasks:

  • Managing and overseeing CAPA, deviation, and change control quality systems
  • Facilitating Change Control Review Board meetings
  • Tracking key quality metrics and KPIs
  • Presenting metrics at regular Quality meetings
  • Maintaining updated knowledge of GxP landscape, regulations, and guidelines
Requirements

Candidates should possess the following qualifications:

  • Bachelor's degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college
  • 6+ years of relevant experience in Quality Assurance, CAPA management, or related field
  • Detailed knowledge of Code of Federal Regulations and International Council for Harmonization Guidelines governing cGMP for Pharmaceuticals
  • Experience with electronic QMS platforms, MasterControl preferred
  • Excellent communication and interpersonal skills


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