Assoc Director, R&D Quality

Job Description Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet. Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. RESPONSIBILITIES Lead and execute internal GxP audits in alignment with the annual and quarterly audit program. Manage and oversee routine and complex audit activities across multiple projects ensuring timely completion. Define and communicate audit plans for contract auditors; train and oversee their activities to ensure alignment with company procedures. Evaluate SOPs systems and documentation for audit readiness regulatory compliance and fitness for purpose. Develop and manage CAPAs and deviations in collaboration with cross-functional teams. Support Veeva QMS record development and oversight of commitments and action plans. Lead inspection readiness activities including training playbook development and SME preparation. Support or lead regulatory inspections including coordination of responses and post-inspection follow-up. Analyze inspection trends and integrate lessons learned into readiness planning and quality improvement. Maintain inspection tracking archiving and metrics for quality management review. Serve as the compliance lead and point-of-contact for assigned Kite R&D functions programs and / or vendors. Act as a Subject Matter Expert performing global risk assessments across assigned functions and programs. Advise study teams and R&D functions on GxP regulatory requirements quality standards and risk mitigation strategies. Deliver GxP and inspection-specific training including standard modules and special topics. Ensure appropriate content and delivery of training materials; promote a culture of quality across the organization. Lead intra- and interdepartmental teams focused on operational improvements and regulatory change preparedness. Initiate and communicate operational changes in a positive and effective manner. Manage audit and compliance metrics to facilitate cross-functional process improvements. Establish and implement new tools and systems to support high standards in compliance. Coordinate and review the work of others; provide matrixed leadership to project teams. Plan and prioritize work effectively to meet tight timelines and evolving business needs. Leadership Provides collaborative matrixed leadership to project and inspection teams. Could manage direct reports. Where applicable hires develops and retains diverse top talent on the team. Sets clear and elevating goals for the team and individuals direct reports. Coaches direct reports on their performance development and career interests. Contributes to resourcing planning and budget ensuring delivery against objectives and with good business judgement and priorities. Ensures own work complies with established practices policies and processes and any regulatory or other requirements. Fosters a commitment to quality in individuals and a culture of quality across R&D. PREFERRED REQUIREMENTS BA / BS or advanced degree in life sciences or related field Significant experience in biopharma quality compliance audits inspections and CAPA management Preferred GCP GCLP and GPV auditing and inspection experience Knowledge & Other Requirements Deep understanding of QMS operations and GxP standards (GCP GLP / GCLP GPV ESC) Strong knowledge of the drug development lifecycle from early research to post-marketing Strategic and analytical skills with ability to assess complex systems and data Proven ability to lead without authority and influence cross-functional initiatives Strong interpersonal communication negotiation and conflict resolution skills Ability to travel 40-50% Ability to travel 40-50% Key Skills Laboratory Experience,Vendor Management,Design Controls,C / C++,FDA Regulations,Intellectual Property Law,ISO 13485,Research Experience,SolidWorks,Research & Development,Internet Of Things,Product Development Employment Type: Full-Time Experience: years Vacancy: 1 Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at Employment Opportunity (EEO) It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. For Current Kite Pharma Employees and Contractors : Please apply via the Internal Career Opportunities portal in Workday. Required Experience : Director Employment Type: Full-Time Experience: years Vacancy: 1 It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs company-sponsored training education assistance social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws. #J-18808-Ljbffr