Senior Manager, Clinical Quality Assurance
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Job Description
Senior Manager leading clinical quality assurance, audits, and regulatory readiness for AbbVie’s global clinical research programs. Supporting quality systems and health-authority inspections across designated regions.
Responsibilities:
- Support assigned countries and region through implementation and execution of proactive quality management activities
- Maintain collaborative relationships with RDQA functions impacting clinical research within designated Affiliates
- Establish relationships with clinical development leaders and staff to advance the AbbVie Quality System and achieve first-pass health-authority approval
- Oversee quality and compliance in a regulated environment, including AbbVie policies, procedures, and country/regional standards and regulations
- Lead or collaborate on risk identification and mitigation/control strategies for clinical research and clinical trials
- Review quality and compliance data periodically for continuous improvement
- Establish quality measures and drive quality strategy in designated countries and region
- Manage fit-for-purpose governance and oversight under the One AbbVie Quality System
- Identify trends, root causes, and potential risks affecting clinical research
- Drive continuous regulatory preparedness
- Work with Affiliates R&D Management on Quality System health and quality/compliance issues
- Maintain awareness of applicable regulations and develop quality standards for assigned countries and region
- Support supplier visits, audits, and vendor qualifications
- Develop inspection strategy and provide inspection-readiness support for local/regional Health Authority inspections
- Provide oversight, support, and follow-up for inspection reports
- Participate in Health Authority inspections as needed
- Determine the need for country/process assessments and audits
- Conduct audits to assess compliance with regulations, guidelines, policies, procedures, and sponsor requirements
- Communicate audit results orally and in writing
- Review and approve corrective action plans and audit responses
- Support robust audit and inspection responses through coaching and education
- Mentor AREA Managers/AREA Associates or line management as an additional lead responsibility
- Report to the RDQA Associate Director or RDQA Global Director, AREA
Requirements:
- 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
- 3 years in leadership positions (people and/or initiatives/projects)
- Strong understanding of local and global regulatory and legal requirements and regulatory agency approaches and perspectives
- 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
- Strong analytical skills and ability to organize work in a logical, thorough and succinct manner
- Effective leadership in interactions with business partners at all levels
- Excellent written and 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 who builds relationships with peers and cross-functionally at global and local levels
- Fluent in additional languages desirable but not required
- Ability to travel as needed in AREA (up to 35%)
Benefits:
- Employees can work remotely
- Equal opportunity employer
- Reasonable accommodation for US & Puerto Rico applicants
- Travel as needed in AREA (up to 35%)
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