We are a small biopharmaceutical company located in San Diego, CA in the Torrey Pines area. Our exciting product is entering late phase clinical trials.
We are looking for a hands-on Quality Assurance Sr. Manager/ Director to lead the quality functions for the overall Quality Assurance Unit. This role collaborates with the GXP (GMP, GLP, and GCP) functional areas in order to ensure quality and compliance in all GXP-related activities. An immediate emphasis on CMC (chemistry, manufacturing and controls) activities will enable internal and external activities leading to submission and approval of a New Drug or Biologics Licensing Application. The selected individual will be responsible for implementing quality systems in support of GMP and GLP activities. The selected individual will lead the quality review of documentation generated at CMOs/CROs in support of manufacturing, release, and stability testing of clinical and commercial material. The selected individual will also implement systems for internal activities to be performed under GXP regulations.
Primary Duties and Responsibilities
•Lead the development of quality systems for policies, processes and procedures with internal and outsourced activities.
•Perform gap analysis of the current quality system and implement necessary changes to support GXP activities. Ensure compliance with applicable industry standards, FDA and global health authority regulations, and ICH guidance.
•Perform annual or biannual review of current standard operating procedures (SOPs), and implement new SOPs.
•Oversee employee SOP compliance and training records.
•Perform quality audits at CRO/CMOs and set up quality agreement with CRO/CMOs. Write audit reports summarizing results.
•Perform quality review of internal documents, including but not limited to protocols for product, processes, batch records, C of As, stability reports, and development reports.
•Conduct or lead corrective and preventive actions in manufacturing using formal problem solving tools and documentation.
•Perform quality review of regulatory submissions, as needed.
•Interact with regulatory authorities (FDA), as needed.