Senior Manager, Clinical Quality Assurance - Americas

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow, across key therapeutic areas including immunology, oncology and neuroscience, plus the Allergan Aesthetics portfolio.

This hybrid role could be based at any of Abb Vie's US locations, such as North Chicago, IL;
Cambridge, MA;
Worcester, MA;
Irvine, CA;
San Francisco, CA; or Florham Park, NJ.

As an independent RDQA Organization, our commitment is to drive quality excellence as a strategic advantage across all stages of discovery and development for the lifecycle of the product, to achieve product realization and accelerate access to innovative therapies for our patients. Abb Vie's R&D global trial footprint has grown because of pipeline growth and the complexity of global development, which has increased the number of global trials in the Affiliates.

The acquisition of Allergan and its integration with Abb Vie have also significantly increased the clinical trials managed from the Affiliates. RDQA AREA focuses on proactive quality and quality output in support of clinical development and the R&D enterprise in designated countries around the world. AREA supports countries in Europe, the Americas and Intercontinental, as defined by Abb Vie. Expected results include quality excellence, achievement of R&D goals for submitting new therapies, adherence to the One Abb Vie Quality System, execution of RDQA Quality System Excellence (CAPA, Change Management, Quality Risk Management, Documentation Standards) and assurance of data integrity.

This position will report to the RDQA Associate Director or RDQA Global Director, AREA.

• Support the assigned countries and region, and implement and execute proactive quality management activities.
• Maintain a close, collaborative relationship with RDQA functions impacting clinical research within designated Affiliates.
• Build working relationships with clinical development leaders and staff to advance the Abb Vie Quality System, drive quality excellence, and achieve first pass approval for market authorization by health authorities.
• Oversee quality and compliance in a regulated environment, including Abb Vie policies and procedures and country and regional standards and regulations.
• Lead and/or collaborate on risk identification and mitigation strategies for clinical research activities, including clinical trials, with periodic reviews of quality and compliance data.
• Establish quality measures and drive quality strategy in designated countries and region.
• Manage governance and oversight in relation to the One Abb Vie Quality System. Identify trends, root causes and potential risks, and drive a continuous state of regulatory preparedness.
• Ensure a consistent understanding of quality requirements for clinical research within Affiliates.
• Maintain awareness of applicable regulations and develop standards to measure quality.
• Support supplier visits, audits and vendor qualifications.
• Develop inspection strategy and provide inspection-readiness support for local and regional Health Authority inspections. Provide oversight, support and follow-up, including inspection report responses, and participate in inspections as needed.
• Determine the need for country and process assessments or audits in collaboration with Clinical Audit and Clinical PM.
• Conduct audits, communicate results, and review and approve corrective action plans and audit responses.
• Support robust audit and inspection responses through coaching and education.
• Mentor AREA Managers and AREA Associates, or take on line management.

• Bachelor's degree required, preferably in Biology, Nursing, Pharmacy or another medical science, combined with equivalent technical experience.
• 8+ years of biopharmaceutical or medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or related development functions, including 3 years in leadership positions (people and/or initiatives/projects).
• Strong understanding of local and global regulatory and legal requirements and of regulatory agency perspectives.
• Thorough knowledge of quality systems, auditing standards and quality management.
• Strong analytical, communication, presentation, negotiation and influencing skills.
• Ability to foster cross-functional collaboration at both global and local levels.
• Additional languages desirable but not required.
• Ability to travel…