Title: Associate Director/Director of Quality Assurance
Cellics Therapeutics, Inc. is looking for an Associate Director/Director of Quality Assurance to lead and support quality assurance (QA) activities related to cGXP in accordance with ICH and FDA regulations and guidelines. The primary function of the QA department is to maintain a robust and effective quality system that delivers reliable and high-quality products that meet all patient and regulatory agency requirements and expectations.
Essential Duties and Responsibilities
- Ensure that products and processes meet company and regulatory requirements for manufacturing activities.
- Maintain a risk-based quality system to support cGXP activities.
- Oversee equipment management programs to establish and maintain compliance with regulatory requirements.
- Review and approve manufacturing-related documentation, including raw material release, batch records, and quality control test reports.
- Oversee the management of all controlled documents, including but not limited to SOPs, Protocols, Reports, Material Specifications, Master Document Copies, Master Batch Records, Certification Documents, Training Documents, Cleaning Documents, etc.
- Oversee the vendor qualification program and the release of incoming materials.
- Identify, review, and approve all deviation and OOS records.
- Identify and assign supporting CAPAs, including tracking closure and proper completion.
- Provide training to laboratory and manufacturing staff on GMP regulations, best practices, and internal requirements.
- Lead the QA team and mentor other QA team members.
- Support colleagues in other functional departments on applicable regulations.
- B.S. degree in a scientific discipline (e.g., biology, chemistry, pharmacology) required. Advanced degree preferred.
- At least 7 years managing a QA program in a GMP environment for drug development (early-stage drug development experience is required; experience in biologics drug development is a plus).
- A proven record of implementing and maintaining quality systems is required.
- Experience with California drug manufacturing license is required.
- Solid understanding of the functional areas of manufacturing, materials management, quality assurance and control, microbiology, and laboratory operations.
- In-depth understanding of GMP regulations, guidance documents, systems, processes, and procedures.
- Strong interpersonal skills.
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers, and management.
- Excellent time management skills and ability to multi-task and deliver high quality results within timelines.
- Great attention to detail.
If interested, please email a copy of your CV to firstname.lastname@example.org.