Clinical Trials QA Director, eTMF, GCP

The Director Clinical Trials QA is responsible for setting the strategic vision for the global clinical quality function, aligning it with corporate objectives, risk tolerance, and evolving regulatory expectations.

Acts as primary QA liaison to executive leadership, regulatory agencies, and external partners for clinical quality matters.

Also, assures compliance of clinical development program with Good Clinical Practice (GCP), regulatory requirements (e.g., FDA, EMA, MHRA, ICH E6(R2)), and company SOPs.

The role provides quality oversight of clinical trial operations, audits, ongoing CRO qualification and management, and inspection readiness, working closely with Clinical Operations, and CROs.

This position has budgetary and supervisory responsibilities.

NOTE :

• Some relocation may be available for this role.

Duties and Responsibilities (Responsibilities include but are not limited to) :

Drive document governance :

Supervisory Responsibilities :

Education / Experience / Skills :

Working Environment and Travel :

ADA :