Supply Quality Management Manager
Job Location:
Newark, DE - USA
Hourly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Location: Newark CA 94560 (Onsite)
Duration: 6 Months Contract (Potential to Extend)
Part-time Opportunity (20-25 hours per week)
Description:
- We are seeking a highly motivated individual in this exciting new area of cancer immunotherapy.
- In this role you will be responsible for the important elements of the Supplier Qualification Management (SQM) program specifically quality agreement negotiation and management.
- Responsible for supplier questionnaire management including improving questionnaire content coordination of questionnaire completion with suppliers and evaluation of responses
- Develop quality agreement templates and establish preferred standard and fallback terms
- Conduct and/or facilitate quality agreement negotiations
- Perform quality agreement periodic reviews
- Assist in supplier qualification activities and supplier monitoring activities
- Assist in departmental and cross-functional process improvement initiatives and special projects as identified by management to support the business need
- Other duties as assigned
Requirements:
- Bachelors degree in engineering Chemistry or Biological Sciences required
- Prior experience in quality assurance/SQM manufacturing QC or quality engineering
- Experience in quality agreement negotiation and management required
- Extensive working knowledge of quality system requirements such as US FDA GMP GCP EMA and ICH guidelines and a proven track record of successfully implementing these requirements
- Excellent interpersonal verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
- Proficient in MS Word Excel and PowerPoint
- Experience with Veeva is a plus but not required
- Candidates must be authorized to work in the US without sponsorship.
Client is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy Allogene is developing a pipeline of off-the-shelf CAR T cell product candidates with the goal of delivering readily available cell therapy on demand more reliably and at greater scale to more patients.
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Why TalentBurst
At TalentBurst we deliver more than talent we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision transparency and results we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits including medical dental vision and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.
Required Experience:
Manager
About Company
REDEFINING THE FUTURE OF CELL THERAPY WITH OUR AlloCAR T™ PRODUCT PLATFORM INNOVATION Multiplex gene-engineering and gene-editing capabilities Proprietary lymphodepletion platform State-of-the-art manufacturing Opportunity for product optimization SEE OUR PIONEERING PLATFORM >> KEY PR ... View more
