What are the responsibilities and job description for the Associate Director, Quality Systems & Operations position at Affini-T?
About Affini-T Therapeutics
Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application of gene editing and synthetic biology, we aim to enhance T-cell fitness to overcome the immunosuppressive tumor microenvironment, with the ultimate goal of inducing long-term responses in patients with solid tumors.Job Summary
Essential Duties & Responsibilities
- Conduct timely and thorough batch record reviews to ensure compliance with regulatory requirements and internal procedures.
- Review manufacturing related deviations and proposed Corrective Actions from CDMO.
- Review Out of Specification (OOS) to determine and resolve issues related to product quality.
- Collaborate with Contract Development and Manufacturing Organizations (CDMOs) to ensure timely disposition of drug product batches.
- Support the Senior Director of Quality in managing internal quality system processes, including document control, training, change controls, deviations, CAPA, and product complaints.
- Act as a Subject Matter Expert (SME) for document control and other quality system processes.
- Maintain current knowledge of industry trends and best practices in quality management.
Required Qualifications
Education and Experience:
- A Bachelor of Science in a scientific discipline is required and a minimum of 10 years of experience in Quality.
- Experience with batch record review and batch disposition.
- Experience in managing document control, deviation, and CAPA.
- Cell and Gene therapy experience is a plus.
- Preferred experience with outsourced manufacturing.
- Proven track record of building relationships and influencing across disciplines and all levels.
- Strong interpersonal skills to effectively communicate with team, peers, Management, and external contacts.
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