Director, Safety. Regulatory Affairs and Medical Affairs Quality Standards
3 weeks ago
Purpose:
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.
AbbVie’s quality foundation resides in the Quality Policy and Quality System as an integrated model in which AbbVie systematically defines quality objectives, both strategic and applicable regulatory requirements.
Director, Safety, Regulatory and Medical Affairs Quality Standards 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, covering the AbbVie drug, device and cosmetic portfolio.
The role oversees generation and assessment of current/new safety, regulatory and medical affairs policies and procedures to ensure that they meet and/or exceed expectations. Serves as thought leader/expert in R&D Quality Assurance strategic insert GxP function process updates, proactively assesses evolving regulatory changes. Generates new approaches to advance quality assurance excellence mindset.
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.
Responsibilities:
In collaboration with applicable GXP RDQA Leaders, lead, develop and implement routine and QA oversight strategies relating to R&D business stakeholders including but not limited to Pharmacovigilance and Patient Safety, Regulatory Affairs and Medical Affairs to ensure optimal QA oversight and continuous improvement.
In collaboration with other RDQA Quality Standards Leads implement process to lead gap assessments of draft and final regulatory intelligence against internal core requirements and SOPs. Ensures effective safety, regulatory and medical affairs Management Review process. Drives continuous improvement through the R&D Quality Plan process.
Oversees the development/implementation of safety, regulatory and medical affairs corporate and/or organizational policies/procedures. Partners with the Director, R&D Quality Assurance on cross-GxP standards and those requiring RDQA Leadership support.
In conjunction with Compliance leaders, review escalation issues to proactively identify emerging trends, including developing and implementing appropriate action plans to ensure strategic continuous improvement and ongoing compliance.
Represents safety, regulatory affairs, and medical affairs in the Quality System Owner Network Governance Structure. Seeks opportunities for simplification and efficiency.
In collaboration with functional QA Leads is responsible for the discovery, evaluation, and potential implementation of safety, regulatory and medical affairs function regulatory requirements. Proactively monitor and interpret the external global regulatory environment for regulatory issues, trends, and changes that have the potential to impact our products.
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.
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
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