Senior Manager, Clinical Quality Assurance

🔥 0 minutes ago

🇨🇦 Canada – Remote

💵 $130k - $180k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 0%

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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 supporting clinical research in 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 under AbbVie policies, procedures, and applicable country and regional standards • Lead or collaborate on risk identification, mitigation, and control strategies for clinical research and clinical trials • Establish quality measures and drive quality strategy in designated countries and region • Manage fit-for-purpose governance and oversight within the One AbbVie Quality System • Identify trends, root causes, and risks affecting clinical research • Maintain regulatory preparedness and support Affiliates R&D Management on Quality System health • Maintain awareness of applicable regulations and develop quality standards for assigned countries and region • Support supplier visits, audits, and vendor qualifications • Develop inspection strategies and provide inspection-readiness support for local and regional Health Authority inspections • Provide oversight, support, follow-up, and inspection-report responses for Health Authority inspections • 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 another medical science, combined with equivalent technical experience • 8+ years of biopharmaceutical / medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or related development functions • 3 years of experience in leadership positions involving people and/or initiatives/projects • Strong understanding of local and global regulatory and legal requirements and regulatory-agency approaches • Ability to maintain a strategic risk focus amid evolving global regulations and expectations • Thorough knowledge of quality systems, auditing standards, and quality management • Strong analytical, organizational, written, oral communication, presentation, negotiation, influencing, collaboration, and networking skills • Ability to work at an experienced level and lead interactions with business partners at all levels • Ability to foster cross-functional collaboration • Fluent in additional languages desirable but not required • Ability to travel as needed in AREA, up to 35%

🏖️ Benefits

• Employees can work remotely • Travel as needed in AREA (up to 35%) • Equal opportunity employment • Reasonable accommodation for US & Puerto Rico applicants

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