Associate Director, R&D Deviation and CAPA Management

职位描述

Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams, and external partners as we strive to cure unmet medical needs?

R&D Quality and Medical Governance is seeking an Associate Director, R&D Deviation and CAPA (Corrective and Preventive actions) Management

In this role you will be responsible for leading the execution and oversight of the internal deviation programme and will assist in the investigation and management of other sources of non-compliance across R&D activities, including clinical development, patient safety and medical affairs.

Primary Responsibilities

• Facilitate and lead investigations surrounding internal deviations

• Maintain oversight of the quality and timeliness of reported deviations and resultant corrective and preventive actions

• Plan, execute and oversee Effectiveness checks following CAPA implementation

• Act as business process owner in the cross-functional team supporting the electronic deviation and CAPA management systems

• Identify and communicate trends for robust mitigation

• Drive for a state of inspection readiness across R&D for relevant process Provide guidance and training on deviation management and process for internal stakeholders

• Cultivate and maintain strategic relationships and collaborations both internally and externally

• Support overall R&D Quality & Medical Governance goals

• Train and manage internal staff

• Lead intra or interdepartmental teams such as improvement initiatives

• Foster a commitment to quality and a culture of quality within the organization

• 10+ Years with BA/BS or 10+ Years with MA/MS/MBA or 8+ Years with PharmD/PhD

• Extensive experience leading GxP quality investigations in the biopharma industry

• Experience of problem solving tools and techniques, e.g. Root Cause Analysis,

• Experience in implementing principles for Quality Risk Management

• Significant experience leading cross functional projects and teams

• Strong verbal and written communication skills and interpersonal skills

• Excellent organizational and project management skills

• Ability to travel approximately 20-30% required.

About Gilead R&D Quality and Medical Governance

Gilead R&D Quality and Medical Governance 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 and Medical Governance 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?