Senior Manager, Clinical Quality Assurance

🔥 1 minute ago

🇨🇦 Canada – Remote

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• 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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