About this role
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
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
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%).
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
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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