Clinical Quality and Compliance Specialist

The purpose of the Clinical Quality and Compliance (CQC) Specialist role is to conduct a broad range of activities that support the CQC department and its sub-groups (Trial Master File (TMF) Compliance, Clinical Compliance, and Clinical Quality) to fulfil their objectives.
Full Time On-Site/Hybrid Quality
Annually: USD 0 - 0
Clinical Quality Compliance Specialist
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Available Locations:
Philadelphia, Pennsylvania, United States
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.

PRIMARY RESPONSIBILITY

The purpose of the Clinical Quality and Compliance (CQC) Specialist role is to conduct a broad range of activities that support the CQC department and its sub-groups (Trial Master File (TMF) Compliance, Clinical Compliance, and Clinical Quality) to fulfil their objectives.

KEY RESPONSIBILITIES

  • Performs Quality Control (QC) review of TMF records for consistency, quality, and regulatory compliance (20%).
  • Files CQC records (e.g., audit certificates) in the TMF.
  • Supports the Clinical Compliance Leads as required (e.g., attends Study Conduct Team meetings, reviews of study-related documentation and provides feedback if requested).
  • Maintains accurate information about Adaptimmune’s clinical trials in clinicaltrials.gov; entering new and updated information and submitting for approval following receipt of information from the Clinical Scientists.
  • Provides support for Inspection Readiness Activities, vendor qualifications, self-inspection projects and audits.
  • Supports the follow-up of Corrective and Preventive Actions (CAPAs) arising from issue management reports and audits.
  • Support the advancement / development of the CQC Program (e.g., Standard Operating Procedure (SOP) review, process improvement initiatives, metric generation etc.).
  • Additional tasks as required.

QUALIFICATIONS & EXPERIENCE

Required

  • Bachelor’s Degree – preferably in a life science, or a combination of education and work experience relevant to the role.
  • Prior experience working for a Sponsor or full-service Contract Research Organization (CRO) in a Good Clinical Practice (GCP) capacity, or a combination of GCP experience and GXP Quality Assurance (QA) experience.

Desirable

  1. Prior experience supporting TMF Operations or Clinical Operations in support of TMF activities.
  2. Prior experience with clinical systems such as electronic TMF (e.g., Veeva Vault), Clinical Trial. Management Systems (CTMS), Quality Management Systems (QMS), Learning Management Systems. (LMS), Interactive Voice/Web Response System/Interactive Response Technology (IXRS/IRT).
  3. Experience preparing for and/or participating in regulatory inspections.
  4. GCP-related certifications (e.g., SoCRA, SQA-RQAP, etc.).

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

Posted 6 months ago

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