Senior Manager, Clinical Quality Assurance

AREA supports countries in Europe, Americas and Intercontinental as defined by AbbVie.

The expected results in the Affiliates are as follows; quality excellence, realization of R&D goals and objectives for submission of new therapies including but not limited to adherence to One AbbVie Quality System, execution of RDQA Quality System Excellence (CAPA, Change Management, Quality Risk Management, Documentation Standards) and the assurance of integrity data. Scope includes R&D and clinical research activities conducted by Affiliates or AbbVie within the region, to achieve first pass approvals thereby advancing the pipeline.

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

Responsabilities

The RDQA AREA Senior Manager will provide support for the assigned countries and region and will be responsible for the implementation/execution of activities related to proactive quality management. The following are key responsibilities:

• Maintain a close, collaborative relationship with RDQA functions impacting clinical research within designated Affiliates in the assigned countries and region.
• Establish collaborative-working relationship with clinical development leaders and staff within designated Affiliates to advance the AbbVie 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 AbbVie policies and procedures and country and regional standards and regulations.
• Lead and/or collaborate on development of risk identification and risk mitigation or control strategies for clinical research activities including clinical trials within designated countries with periodic reviews of quality and compliance data for the purposes of continuous improvement.
• Establish quality measures with the desire to achieve RDQA quality goals. Drive quality strategy in designated countries and region in conjunction with other RDQA AREA personnel.
• Manage governance/oversight that is “fit for purpose” and in relation to the One AbbVie
• Quality System. Identify trends, root causes, and potential risks to mitigate and/or prevent issues that impact clinical research. Drive vision of continuous state of regulatory preparedness.
• Ensure consistent understanding of the quality requirements for clinical research activities within Affiliates, works closely with Affiliates R&D Management on health of Quality System, identifies issues of quality and compliance that will impact overall goals and desired outcomes.
• Maintain awareness of all applicable regulations and develop appropriate standards to measure quality in assigned countries and region relating to clinical research.
• Support necessary supplier visits, audits and vendor qualifications
• Develop inspection strategy in collaboration with AREA Associate Director and relevant functions and provide inspection-readiness support for all local / regional Health Authority inspections.
• Provide oversight, support and follow-up (inspection report response) for local Health Authority inspections with employees and management in assigned countries and region. Participate in Health Authority inspections as needed.
• Determine need for country/process assessments/audits in collaboration with Clinical Audit and Clinical PM.
• Conduct audits as required to assess compliance with regulations, guidelines, policies and procedures and Sponsor requirements. Effectively communicate audit results, both orally and in writing. Review and approve corrective action plans/audit responses.
• Support the development of robust audit and inspection responses through coaching and education.
• Mentor AREA Managers/AREA Associates or line management as additional Lead responsibility

Qualifications

Qualifications Required

• Bachelor's degree required preferably in Biology, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience. 8+ years of biopharmaceutical /medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or other related development functions that includes 3 years in in leadership positions (people and/or initiatives/projects).
• Strong understanding of local and global regulatory and legal requirements and of the approach and perspectives of regulatory agencies. Ability to ensure strategic risk focus with evolving global regulations and expectations. Agile and able to respond rapidly to unplanned events and changing regulatory requirements and expectations.
• Thorough knowledge of quality systems, auditing standards and quality management.
• Motivates and can influence others, including those over whom they have no direct authority.
• Strong analytical skills with an ability to organize work in a logical, thorough & succinct manner.
• Ability to work at an experienced level, demonstrating effective leadership in interactions with business partners at all levels.
• Excellent written & oral communication skills including presentation and influencing skills.
• Strong negotiation, influencing and collaborating abilities with excellent networking skills.
• Ability to foster cross functional collaboration teams.
• Strong team player or team lead and builds relationships with peers and cross-functionally at both global and local levels to drive performance.
• Fluent in additional languages desirable but not required.
• Ability to travel as needed in AREA (up to 35%).

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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