Senior Manager, Clinical Quality Assurance

🔥 1 minute ago

🇨🇦 Canada – Remote

💵 $134k - $184k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

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 country/regional standards • Lead or collaborate on risk identification and mitigation/control strategies for clinical research and clinical trials • Review quality and compliance data to support continuous improvement and establish quality measures • Drive quality strategy across designated countries and region with RDQA AREA personnel • Manage fit-for-purpose governance and oversight aligned with 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 strategy and provide inspection-readiness support for local and regional Health Authority inspections • Provide oversight, support, and follow-up for inspection reports and participate in inspections as needed • Determine need for country/process assessments and audits; conduct audits as required • 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

🎯 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 • At least 3 years in leadership positions involving people and/or initiatives/projects • Strong understanding of local and global regulatory and legal requirements and regulatory agency perspectives • Ability to apply strategic risk focus amid evolving global regulations and expectations • Agile response to unplanned events and changing regulatory requirements and expectations • Thorough knowledge of quality systems, auditing standards, and quality management • Strong analytical, organizational, written, oral communication, presentation, negotiation, influencing, and collaboration skills • Ability to work effectively with business partners at all levels • Ability to foster cross-functional collaboration and build global and local relationships • Fluent in additional languages desirable but not required • Ability to travel as needed in the AREA, up to 35%

🏖️ Benefits

• Remote work available • Equal opportunity employment • Reasonable accommodation for US and Puerto Rico applicants • Opportunity to work on innovative medicines and solutions addressing serious health issues • Professional mentoring responsibilities and leadership development through mentoring

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume