The Development Sciences Quality (DSQ) group is focused on partnering with Development Sciences functional groups, clinical development 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, TMF and records management, inspection readiness and response support and training development and delivery.
The Associate Director's (AD) primary role is to set the strategy and direction of the DSQ Trial Master File and Records Management program and to provide leadership and management to the DevSci Records Management (DSRM) team. The AD may also have DSQ leadership and management responsibilities for oversight or participation in other DSQ initiatives involving the development and execution of DSQ's Quality Management System.
I. Trial Master File (TMF):
Oversee the strategic direction and process improvement of the DSQ TMF program
Manage the development, implementation and execution of TMF plans across programs
Ensure overall completeness and quality of TMFs
Partner with Functional Areas on audit/inspection preparation, participation and follow-up
Oversee the development, implementation and maintenance of a robust TMF metrics process
II. Records Management:
Oversee the implementation of standards and processes for DevSci records management to verify compliance with relevant regulations
Oversee execution of processes associated with the storing, archiving, indexing, scanning and classifying records
III. General Leadership Responsibilities:
Leadership and management of DSRM personnel goals, deliverables and professional development
Management of quality issues or events that arise within DevSci functions, studies or project teams
Risk based quality assessments of processes and procedures, and communication of findings to respective DevSci functional stakeholders and DevSci Management
Maintaining ongoing awareness of industry and organization-wide best practices for quality and share information across DSQ and DevSci
Identifying and assessing opportunities to develop and improve key elements of the DevSci Quality Management System.
This role may have up to 6 direct reports and may manage up to 2 hierarchical levels of reports.
EDUCATION AND EXPERIENCE
BA/BS in life sciences or technical area; advanced degree preferred. Experience in lieu of education may be considered.
Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification a plus
Associate Director Level: 8+ years of relevant pharmaceutical industry experience; Director Level: 12+ years of relevant pharmaceutical industry experience
Associate Director Level: 3+ years of people management experience; Director Level 5+ years of people management experience