AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality
medicines and products that solve serious health issues and have a remarkable impact on people’s
lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is
committed to driving quality excellence across all stages of discovery and development for the
product’s lifecycle to achieve product realization and accelerate access to innovative therapies and
products for our patients.
Patient needs, stakeholder demands, industry innovation, regulatory landscape, and AbbVie’s evolved
business strategy are complex, rapid pace, and dynamic. Emphasizing and embedding quality in the
execution of clinical trials, post market vigilance and post market studies, assures patient safety,
maintains data integrity, fosters regulatory compliance, and contributes to the overall success of
drug/device development programs.
Senior Manager, Safety, Medical & Regulatory Quality contributes to the management of a RDQA
global Safety, Regulatory Affairs (RA) or Medical Affairs (MA) QA team which provides independent
quality oversight of safety activities executed by AbbVie’s R&D and non-R&D business functions,
covering the AbbVie drug, device and cosmetic portfolio. The role contributes to quality excellence
through successful business partner collaboration and provides expert technical quality support and
consultation to R&D colleagues and business partners. May support Regulatory Agency inspections.
The role reports to the Director Safety, Medical & Regulatory Quality. There is an expectation that in
performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the
organization at large.
Responsibilities:
• Contribute to a state of continuous compliance with global regulations, AbbVie policies and
procedures and regulatory preparedness for relevant Regulatory Authority Inspections and
pharmacovigilance and safety inspections and deliver business results while positioning
AbbVie for future success
• Consistently demonstrate AbbVie’s Ways of Working and Leadership Attributes including a
collaborative mindset and people leadership manage innovation to reality.
• Fulfil expectations and goals to ensure organizational success. Embody a culture of open and
honest communication where all are encouraged to express their views, offer suggestions
and experiment for improvement.
• Support and execute a holistic quality assurance model for applicable GxP activities, inclusive
of internal and vendor performed activities and ensure integration with interfacing GxPs and
cross functional alignment. Support the delivery of innovative quality strategies and solutions through influence and collaboration with business partners to support effective and timely solutions/responses to
compliance issues/questions including audit/inspection findings impacting safety, RA and
MA.
• Determine and evaluate risks impacting compliance with GxP requirements and proposing
suitable mitigations.
• Support business process owners directly to ensure quality is integrated at all stages of
process development.
• Actively participate in front and/or back-room Regulatory Authority inspection activities to
enable successful inspections with safety, RA and MA topics in scope.
• Is recognized as a partner for consultation regarding worldwide safety, regulations and
corporate policies, especially for CAPA and associated Quality disciplines.
• Generate, analyze and report metrics to demonstrate key aspects of compliance status,
escalating issues in a timely manner for earliest resolution and ensuring the value of QA is
recognized and acknowledged
• Contribute to the development and implementation of systems and processes required to
support implementation of global QA strategies. Contribute with applicable RDQA business
functions to provide support, input and consultation to ensure an inclusive and effective
RDQA audit program.
• Drive necessary change and efficiency through the provision of effective feedback and
recommendations; persists in pursuing and achieving organizational goals and objectives.
• Create an impact by modeling the AbbVie Behaviors in a consistent and visible manner in the
conduct of all responsibilities.