Postat în: Altele în Chicago | Adăugat pe site: |
Job Description
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.
Director, Medical Affairs Quality Assurance is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which provides independent quality oversight of GxP activities executed by AbbVie’s Medical Affairs enterprise, including but not limited to non-interventional studies, medical information and other regulatory commitments., covering the AbbVie drug, device and cosmetic portfolio. The role drives quality excellence through successful business partner collaboration and provides expert technical quality support and consultation to R&D colleagues and business partners. Will be a primary RDQA contact for Regulatory Agency inspections with safety, RA or MA in scope.
The role reports to the Senior Director of Safety, Vigilance and Medical Affairs Quality Assurance. 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:
Lead a team to drive a continuous state of compliance with global regulations, AbbVie policies and procedures and regulatory preparedness for GxP regulatory 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. Effectively manage performance inclusively and equitably; provide timely feedback, appropriately reward and recognize valuable achievement, develop talent and create a succession pipeline. Create a learning environment, embrace the ideas of others and manage innovation to reality.
Establish high expectations and goals to ensure organizational success and lead staff to meet or exceed those expectations. Encourage a culture of open and honest communication where all are encouraged to express their views, offer suggestions and experiment for improvement.
Establish and lead a holistic quality assurance model for Medical Affairs, inclusive of internal and vendor performed activities. Ensure integration with interfacing GxPs and cross functional alignment.
Partnering with Medical Affairs and Epidemiology establish and maintain a proportionate quality assurance oversight model for non-interventional studies and regulatory commitments.
Deliver innovative quality strategies and solutions through influence and collaboration with business partners at all levels, including senior management, to support effective and timely solutions/responses to compliance issues/questions including audit/inspection findings impacting safety, regulatory and MA.
Determine and evaluate risks impacting compliance with GxP requirements impacting MA activities and proposing suitable mitigations.
Support business process owners directly to ensure quality is integrated at all stages of process development.
Actively participate and lead front and back-room GxP inspection activities, with direct involvement that includes expert guidance to enable successful inspections with safety, RA and MA topics in scope.
Is recognized as a key resource for consultation regarding worldwide MA and non-interventional research 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.
Lead development and implementation of systems and processes required to support implementation of global QA strategies. Collaborate with applicable RDQA business functions to provide 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.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
