- Gilead Sciences
- $132,420.00 -206,040.00/year*
South Richmond Hill
102-98 121st St
We are seeking a highly motivated individual to join us as an Associate Director, Quality Assurance. Reporting to the Site Quality Head in Oceanside, CA, you will direct the activities of the plant Quality Assurance department and coordinate the total plant quality assurance effort to ensure conformance to Kite Pharma quality standards and government regulations. You will also provide objective evaluation of process performance and product quality and develop staff for continual contributions towards plant quality goals. In addition, the Associate Director, Quality Assurance will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and Kite quality practices and be accountable for managing the QA group, its people, projects and timelines.. Additional Responsibilities (include but are not limited to):. Lead the Quality Assurance staff including recruitment, performance management, hiring along with staff training and development.. Implement and manage Kite Pharma Quality Systems for commercial viral vector manufacturing site.. Review batch-related documentation, and ensure resolution of issues to release product.. Oversee the product and raw material disposition process.. Manage Change Control system and ensure proper maintenance and approval of cGMP documents. Ensures change controls are initiated, evaluated and implemented appropriately for all regulated changes.. Manage the Deviation and CAPA system and ensure timely closure and effectiveness of investigations and corrective and preventive actions.. Conduct effective root cause analysis and implement corrective action and preventative action.. Support quality assessments of internal operations to analyze compliance and assess risk.. Host/support regulatory inspections, internal audits, and external audits from partners.. Review technical/ investigation reports as appropriate.. Review and approve proposed changes to systems, and procedures.. Provide QA guidance to product development projects and technical transfer activities.. Coordinate and facilitate Quality Management Review for the commercial viral vector manufacturing site.. Ensure all product-related Deviations and CAPAs are initiated, investigated and resolved, as needed.. Participate in Material Review Board meetings to ensure non-conforming material is appropriately dispositioned.. Develop and implement Quality on the floor process.. Ensure process control measures are in place and followed in product manufacturing.. Maintain and reports monitoring and control metrics for process performance and product quality.. Perform duties as needed. Skills/Qualifications. 10+ years of experience with BS degree in the biological sciences or related field. 8+ years of experience with MS degree in the biological sciences or related field. 5+ years of direct management/leadership experience in a pharmaceutical or biologics operation.. Thorough knowledge of cGMP regulations, quality systems and regulatory requirements.. Experience in identifying, writing, evaluating and closing CAPAs.. Experience with conducting and managing internal and external audits.. Strong knowledge of change control practices/strategies.. Proficient in MS Word, Excel, Power Point and other applications.. Ability to effectively negotiate and build collaboration amongst individuals.. Demonstrated ability to develop, coach, and mentor key employees. Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.. Preferred: ASQ, Black Belt/Green Belt certifications.. Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.. Focused on the Cure.. Kite, a Gilead company, is dedicated to achieving one of the most ambitious goals of 21st century medicine: curin...
Up to 10% domestic travel
Associated topics: administrative, administrative staff, associate, beverage, front desk, front office, operations director, records management, staff, support
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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