Title: Associate Director/Director of Quality Assurance
Cellics Therapeutics, Inc. is looking for an Associate Director/Director of Quality Assurance (level dependent on experience) to support and promote 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 all equipment calibration and preventive maintenance reports and supporting documentation.
- Review and approve manufacturing-related documentation, including raw material release, batch records, and quality control test reports.
- Manage 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.
- Implement and manage the vendor qualification program and responsible for 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 GLP/GMP regulations, best practices, and internal requirements.
- 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 GLP/GMP environment for drug development (preferably with some early-stage drug development experience in addition to later stage development experience).
- Must have a demonstrable record of implementing and maintaining quality systems.
- Solid understanding of the functional areas of manufacturing, materials management, quality assurance and control, microbiology, and laboratory operations.
- In-depth understanding of GLP and GMP regulations, guidance documents, systems, processes, and procedures.
- Experience with Aseptic Clean Room Environments.
- Strong interpersonal skills.
- Excellent verbal and written communication skills and ability to communicate effectively with site personnel, peers, and management.
- Solid time management skills and ability to handle multiple tasks and deliver high quality results within set timelines.
- Great attention to detail.
If interested, please email a copy of your CV to firstname.lastname@example.org.