The Development Sciences Quality (DSQ) group is focused on partnering with Development Sciences functional groups, project teams and study teams to proactively promote, facilitate and verify the implementation of, and adherence to, good quality practices across the drug development lifecycle in order to be inspection ready at all times. DSQ achieves this by implementing, maintaining and continuously improving a quality management system which includes robust quality operations oversight, controlled document management, eTMF and records management, inspection readiness and response support and training development and delivery.
The Senior Director position is a leadership role with substantial strategic input and organizational change opportunity in DSQ Quality Operations. At this stage, deep expertise in leadership and people management is achieved, and the Senior Director is active in motivating, inspiring, training and enabling others in career development. The Senior Director shapes and defines the organizational strategy, and in so doing, demonstrates a mastery of navigating myriad complex and ambiguous DSQ and organization-wide scenarios.
The Sr. Director demonstrates mastery skills in all DSQ core and technical competency areas.
Clinical Trial Risk Management
Quality Guidance on Essential Study Documents and Regulatory Submission Documents
Quality Process Improvement
Inspection / Audit response and CAPA follow-up
Inspection Activity Awareness
The Sr. Director must seek to effectively lead the organization, build a strong team by coaching and mentoring others, make impeccable decisions, and ensure the success of the business. To achieve these ends, mastery of all core competencies is essential. The Sr. Director should:
Similarly, mastery of all technical competencies for the DSQ group will position the Sr. Director for success in this highly strategic position.