Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is responsible for design, delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Company’s Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. US, EU Directives, US FDA, PMDA, ICH). Responsibilities
Independently conduct audits
Oversee and guide conduct of CQA audits of study sites, clinical vendors, clinical documents, and internal process audits
Facilitate Sponsor health authority inspections of global clinical facilities and study sites
Provide skill-building interventions for CQA staff through cross-functional/ external partnerships to reskill/ upskill and adapt the workforce to evolving technologies.
Potential for direct people management.
Requirements
Bachelor's degree in an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research or operations or related area. Prior experience in site monitoring and study management is preferred.
Strong knowledge of multiple therapeutic areas, eg. neuroscience and oncology, and ability to translate key protocol objectives into auditable activities
5+ years of experience in GCP auditing.
Substantial experience in inspection management.
Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials.
Demonstrated ability to effectively influence and collaborate with senior stakeholders, maintaining Quality's independence and authority in challenging and high-pressure situations.
Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
Knowledge of data integrity controls and systems quality for clinical area
Strong analytical skills and report writing skills
Knowledge of GxP systems including computer system validation and associated regulations, recommended.
Ability to Travel (approximately 15%)
Base salary range: $195,000 -$256,000 per year. This is the anticipated salary range for fully qualified candidates. The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry, education, etc.
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