Senior Manager/ Associate Director, Clinical Quality
2 weeks ago
**Company Background**
Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors.
Tessa’s lead autologous therapy is in late-stage clinical development for treatment of lymphomas. It has shown strong clinical responses in patients with relapsed/refractory classical Hodgkin lymphoma, based on which it was granted the RMAT designation by the U.S. FDA and the PRIME designation by EMA.
Tessa is also developing a novel, differentiated, allogeneic “off-the shelf” cell therapy platform to create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers. A therapy using this platform is being evaluated in an ongoing clinical trial in United States.
**Job Position**
Senior Manager/ Associate Director, Clinical Quality
**Responsibilities**
- Responsible to lead and direct the Clinical Quality Process
- Provides QA oversight of the Clinical Quality Process to ensure that clinical trials are being administered per current GxP and regulations
- Leads, supports the qualification of Apheresis Centers, Hospital sites, CROs and any other suppliers involved in the clinical trial.
- Implements, maintains and reviews the Clinical Quality Process according to applicable current GxP and regulations
- Owns policies and procedures of Clinical Quality Process
- Partners with and communicates to functions to ensure the Clinical Quality Process is executed according to established policies and procedures
- Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the Clinical Quality Process
- Ensures deviations from Clinical Quality Process are documented and investigated
- Develops strategies for Clinical Quality Process to ensure a state of inspection readiness
- Lead, participates and supports inspections, internal and external audits and Quality Management Review
- Escalates quality and compliance risks to Department Head
- Supports improvement initiatives, programs and projects of Clinical Quality Process
**Requirements**:
- Advanced Degree / Degree in Science, Pharmacy, Pharmaceutical Science or equivalent with preferably more than 10 years of relevant work experience in Clinical Quality Management which includes quality audits and providing quality oversight for clinical trials.
- Experienced in oncology trials
- Good understanding of current Good Clinical Practice requirements
- Experienced in conducting and/or facilitating Clinical Trial Risk Assessment
- Familiarity with regulatory requirements pertaining to clinical trials is preferred.
- A team player who is able to coordinate and interact with cross-functional departments, work independently and / or within team(s) with minimum guidance.
- Able to multi-task and work in a fast-paced environment.
- Highly motivated individual, with strong focus on safety, quality and deliverables.
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