Senior Manager, Safety, Medical & Regulatory Quality

Company Description

About Abb Vie

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

Abb Vie 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 Abb Vie’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 Abb Vie’s R&D and non-R&D business functions, covering the Abb Vie 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 (Abb Vie'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, Abb Vie policies and procedures and regulatory preparedness for relevant Regulatory Authority Inspections and pharmacovigilance and safety inspections and deliver business results while positioning Abb Vie for future success
• Consistently demonstrate Abb Vie’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…