Manager, Quality & Compliance (Good Clinical Practice)

Company Background

Tessa Therapeutics is a clinical stage biopharmaceutical company with the scientific vision of revolutionizing the treatment of cancer by redirecting the body’s potent anti-viral immune response to recognize and kill cancer cells. Tessa’s core virus-specific T Cell (VST) platform has shown compelling results in the treatment of solid tumors, and the company is building a portfolio of therapies addressing a wide range of tumors by combining the qualities of its T cell platform with complementary technologies. Tessa’s lead Phase III trial for nasopharyngeal carcinoma (NPC) is the world’s largest Phase III T cell immunotherapy trial for any cancer indication. The company has built up robust operational and supply chain capabilities to successfully deliver autologous T cell therapy treatments to a large patient pool across five countries. The combination of technologies from its academic, clinical, and commercial research partners have enabled the company to create a fully-integrated approach to the treatment of cancer with immunotherapy.

Our mission is to cure cancers and save lives with our innovative and widely accessible immunotherapies.

We are looking for highly motivated and enthusiastic individuals who are interested to be part of our team.

 

Job Position

Manager, Quality & Compliance (Good Clinical Practice)

Reports to

Associate Director, Quality Assurance

Job Description

This role is responsible for Good Clinical Practices (GCP) oversight and for assuring compliance projects and programs with Tessa Standard Operating Procedures (SOPs), Policies and all applicable worldwide regulations and guidelines (US FDA, EU Directives, ICH and National regulations),

This position is also responsible for internal quality and compliance reviews (SOPs, interviewing appropriate personnel, and/or reviewing study documentation) and for the communication and report out of such activities (compiling observations) including any follow up needed (CAPA completion).

 Provide GCP compliance support for assigned studies/projects by:

    • Participating in study team meetings
    • Providing GCP compliance advice to Clinical Operations (teams)
    • Preparing audit plans
    • Overseeing work performed by contract auditors
    • Presenting GCP requirements at Investigator Meetings
    • Independently perform domestic and international audits according to an audit plan, applicable regulations and Tessa SOPs, including audits of:
  • Clinical Service Providers
  • Investigator sites
  • Internal processes
  • Documents for regulatory submissions

Participate as the ‘voice of quality’ in clinical trial study operations e.g. work with relevant personnel to ensure that associated activities are conducted in accordance to the corresponding study protocol and relevant Company procedures / instructions.

Proactively determine regulatory, compliance and quality risks and address them via integration into the site audits / assessments.

Act as a Subject Matter Expert in clinical compliance matters.

Participate in the general QA activities and assist in areas as regulatory submission, deviation review and change assessment, etc.

Perform review of relevant documents for compliance with Standard Operating Procedures across different products.

Conduct relevant quality training, as assigned.

Assist in internal / external audits.

Perform other ad-hoc duties as requested by manager / supervisor.

Requirements

Degree in Biomedical Science / Biochemistry / Microbiology / Biotechnology or any scientific / technical field with at least 5 years of hands-on experience in regulated pharmaceutical industries and / or regulatory agencies, with a minimum of 5 years in GCP compliance.

Good experience in GCP auditing of clinical sites and service providers

Experience in developing quality management plans

Good understanding of quality management principles; minimum of 3 years in leading quality audits (preferably 3rd party and / or 2nd party) with ASQ Certified Quality Auditor (CQA) or other equivalent international certification desirable

Broad pharmaceutical experience is preferred

Able to identify problems, troubleshoot and complete or coordinate corrective actions.

Possess good people management skills.

Strong planning and prioritization of activities for self and team without supervision.

Ability to communicate (both orally and written) effectively in professional manner with peers and management.

Excellent interpersonal and leadership skills, ability to work cross-functionally.

Excellent written and verbal communication skills in both English.

High attention to details, well organised and effectively manage multiple projects.

Able to travel at least 30% of the time.