Associate Director, R&D Corrective Actions
4 weeks ago
Description
Associate Director, R&D Corrective Actions & Preventive Actions (CAPA) Operations Management
Location: Stockley Park or Cambridge
The Associate Director of R&D CAPA (Corrective and Preventive Actions) Operations Management is responsible for overseeing the R&D CAPA program and associated processes, ensuring its effectiveness and continuous improvement. This role involves managing CAPA administration, CAPA training, setting record standards, and maintaining high-quality standard for records and data. The successful candidate will collaborate with various business areas, lead strategic process improvement projects, support quality forums, and establish CAPA operational measures to ensure the organization’s compliance and quality objectives are met.
This role reports into the R&D Quality Issue Management function, which is responsible for driving the integration and peak performance of R&D’s Quality Management System elements of Deviation, CAPA, and Escalation across Clinical Development and Post-Marketing.
PRIMARY RESPONSIBILITIES
Lead the R&D CAPA program, ensuring adherence to regulations and industry best practices. Develop and maintain CAPA procedures, policies, and documentation specific to R&D activities. Establish a continuous improvement program for CAPA operations, driven through performance measures and lesson’s learned opportunities. Implement, monitor and report CAPA performance measures at senior leadership meetings and quality forums including connections to continuous improvement and overall return on investments. Team Lead for CAPA Operations, includes management of both employees and contractors. Collaborate with cross-functional teams to develop and implement effective and timely CAPAs. Approve all R&D originating CAPA Plans and approve all CAPA closures. Monitor the effectiveness of implemented CAPAs through regular follow-ups. Support business and investigation teams on quality issues/events investigations. Interface with internal and external stakeholders, including presenting at appropriate engagements, building visibility into R&D’s CAPA strategy and overall impact on QMS performance. Responsible to the continued maturity of the CAPA program, including quarterly report out to senior leadership through management reviews. Prepare for and support regulatory inspections and audits related to R&D CAPA activities/operations. Stay informed of regulatory changes and industry trends affecting R&D quality management. Collaborate with departments across R&D to ensure effective integration and use of CAPA system and procedures. Support the development and training of internal staff, including fostering a commitment to quality in individuals and a culture of quality within the organization. Develop and deliver training and learning programs related to CAPA processes and quality systems for R&D staff. Mentor and coach R&D team members on effective CAPA management and problem-solving techniques.BASIC QUALIFICATIONS
Bachelor’s degree in a relevant field (e.g., Biotechnology, Biochemistry, Molecular Biology, Engineering). Advanced degree preferred. Minimum of 8-10 years of experience in the biotechnology or pharmaceutical industry, with a focus on CAPA management and Quality Systems. Strong knowledge of GxP regulatory requirements (FDA, EMA, ICH) and industry standards. Proven track record in lean six sigma, total quality system or similar methodologies. Experience in leading investigations, root cause analysis, and CAPA implementation within an R&D/Manufacturing environment. Excellent analytical, problem-solving, and decision-making skills. Strong leadership and project management abilities. Excellent communication and interpersonal skills. Ability to work effectively in a fast-paced, dynamic environment.When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
ABOUT R&D QUALITY
Gilead R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.
We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career. Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?
ABOUT GILEAD
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Equal 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 individual’s 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.
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