Layer, Chiang, et al. Genome Biology
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.
•BA/BS in scientific discipline with 10 plus years’ industry experience in Quality Assurance; an advanced degree is preferred.
•Extensive knowledge of GCP, GLP, and GMP regulations.
•Previous hands-on experience in establishing and/or enhancing effective development and commercial GXP quality infrastructure and systems compliant with US and international requirements, previous experience with NDA/BLA filing is preferred.
•Working knowledge of the drug development process and prior experience working with CRO/CMOs.
•Strong management and interpersonal/communication skills and the ability to deal effectively with a variety of personnel including medical, scientific, commercial and operational staff.
•Superb attention to detail.
•Proven ability to succeed in a fast-paced environment.
•Excellent written and verbal communication skills.
•Excellent organizational skills and ability to adhere to timelines.
•Competent computer skills with the following programs: MS Word, PowerPoint, Excel and MS Project; ability to use ISI writer or comparable templates.
•Some travel (up to 10%) is expected.
Interested parties shall submit a cover letter and CV or resume, as directed in this ad. We will contact qualified candidates via email for next steps and to provide more information. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, gender, age, and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity, and competitive salary and benefit packages are available for qualified candidates.
Qualified candidates, please submit your resume to: firstname.lastname@example.org