Establish, implement and maintain a program to assure that Early Phase/Oncology facilities remain in compliance with internal policies and procedures and all applicable worldwide regulations. Interpret, explain and apply current regulations, guidelines, policies and procedures to ensure a fit-for-purpose QA oversight program.
Key Responsibilities Include:
Develop strategy for the design, implementation and maintenance of a fit-for-purpose QA oversight program for Phase 1 Units and research facilities conducting Phase 1 and 2 oncology clinical studies.
Lead the RDQA process for qualification and ongoing program assessment of facilities conducting early oncology clinical development studies. Provide measurement and analysis of compliance and drive process improvement.
Provide feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions and commitments have been properly implemented, proven to be effective and are being maintained.
Coordinate across RDQA to leverage expertise and procure resources, as necessary, to support the program. Continue to provide support for other GXP Compliance audits, as necessary.
Collaborate with clinical teams at ABR and Stemcentrx to ensure appropriate QA support for Phase 1 and 2 oncology studies to meet project timelines. Provide recommendations and assist in the resolution of issues.
The position provides an active role within the corporation as expert in GCP requirements. The strategic focus is for early detection and prevention, followed by correction of issues.
Bachelor’s degree in physical science, life science, pharmacy or engineering or equivalent experience required.
5-10 years’ experience in Quality Assurance/Regulatory Affairs (Pharmaceutical preferred), 5-10 years’ experience Clinical Research Development, 3-5 years’ QA Auditing Experience (Clinical Auditing preferred). Minimum of 10 years total combined experience required. (Not necessarily the sum of the above)
Must have a technical background and requires a thorough understanding of the audit process and an extensive knowledge of global GCP regulations.
In-depth knowledge of the pharmaceutical development process.
Demonstrated ability to influence cross-functionally and at all management levels.
The individual must have excellent oral/written communications skills, interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational/administrative skills and sound judgment.
At AbbVie, we have the expertise of a proven pharmaceutical leader and the focus and passion of an entrepreneur and innovator. The result is something rare in health care today – a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people and societies around the globe.