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Full-Time

Director – Quality Assurance Operations

Posted on 7/16/2024

Adicet Bio, Inc

Adicet Bio, Inc

51-200 employees

Develops genetically modified T cells for cancer

Biotechnology

Compensation Overview

$188k - $260kAnnually

Expert

San Carlos, CA, USA

Category
QA & Testing
Operations & Logistics
Quality Assurance
Required Skills
Communications
Management
Quality Assurance (QA)
Requirements
  • Bachelor’s Degree in scientific or relevant disciplines in life sciences
  • 10+ years of experience within the life sciences industry, preferably biotechnology, pharmaceuticals, or other regulated therapeutic environment with 6+ years in a Quality Assurance role
  • 5+ years of direct management experience
  • Demonstrated mastery of cGMP regulations and quality systems
  • Thorough knowledge of applicable regulatory requirements (FDA CFR, EMA, ICH, ISO, any other global laws/regulations)
  • Experience with Health Authority Inspections
  • Proficiency with electronic management systems (such as LIMS, eQMS,)
  • Strong interpersonal and communication skills: written and oral
  • Outstanding planning, organization, and multitasking skills
  • Travel as required
  • Prior cell therapy experience is a plus
Responsibilities
  • Ensure current Good Manufacturing Practices (cGMPs) compliance for clinical manufacturing of phase I/II/III investigational product
  • Accountable for lot disposition activities including batch record review, in-process/release and stability testing review
  • Review approval of development activities in preparation for GMP such as development studies/reports, engineering activities, etc.
  • Collaborates with cross functional teams and champions the Quality Risk Management Program
  • Responsible for the phase appropriate validation program
  • Serves as team leader in quality related discussions, investigations, risk assessments, change controls, etc.
  • Partners with Facilities and functional SMEs to support equipment qualifications and lifecycle management
  • Collaborates with Quality Systems to manage the cGxP training program for internal manufacturing related functions
  • Represents the organization during third-party audits and inspections as required
  • Provides technical expertise and guidance in conducting investigations in regard to quality deviations, laboratory investigations/change controls systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution
  • Provides oversight for the raw material program, including raw material QA release
  • Develop and implement procedures, programs and policies that support quality assurance functions and assure cGxP compliance
  • Supports regulatory submissions of quality related sections
  • Be a champion for continuous improvement. Identifies and drives continuous improvement initiatives and monitors progress of deliverables
  • Other duties as required.

Adicet Bio, Inc. is a pioneering biotechnology company focused on the development of innovative gamma delta T cell therapies for cancer. This firm's work in advancing genetically modified T cells that selectively target tumors with chimeric antigen receptors and T cell receptor-like antibodies positions it as a leader in oncology treatment advancements. The dedication to enhancing tumor targeting and improving treatment persistence underscores a strong commitment to patient care and scientific excellence, making it a distinguished workplace for professionals passionate about making significant impacts in cancer treatment.

Company Stage

IPO

Total Funding

$243.6M

Headquarters

Redwood City, California

Founded

2014

Growth & Insights
Headcount

6 month growth

-4%

1 year growth

0%

2 year growth

42%