Senior Manager, Medical & Affiliates, R&D Quality

Seeking a Sr. Manager/Associate Director of Medical & Affiliates Research & Development (R D) Quality to play a pivotal role in reinforcing and sustaining a strong culture of quality, compliance, governance, and risk management for our cross-therapeutic area medical affairs activities. The Sr. Manager/Associate Director will support Medical & Affiliates R D Quality operations by promoting document management, monitoring initiatives, independent projects and learning solutions that are managed by R D Quality Process, Documentation and Learning to advance a culture of quality and compliance across the company. Primary Responsibilities Partner with Medical & Affiliates Quality Business Partner team to support the ecosystem of medical affairs and Affiliates quality operations, including:

• Synthesizing Quality issues arising from deviations, inspections, and audits; supporting the development and maintenance of Medical Affairs (MA) process documentation
• Creating analytic tools to enhance data insights and leadership communications
• Supporting initiatives and projects led by Quality Business Partners in collaboration with the business
• Developing sophisticated presentations to support project execution and decision making The role requires the ability to remain flexible and effectively manage multiple priorities simultaneously. Pharmaceutical industry experience is preferred. Audits, Inspections & Self-Assessments
• Support team needs in their conduct audits, inspections, and self-assessment activities in coordination with functional business partners
• Support internal audit and regulatory inspection deliverables, including readiness preparation, inspection execution, and response activities, as needed
• Assist with the resolution of relevant audit and inspection findings and the implementation of corrective actions Medical Governance Monitoring & Reporting
• Support the development of reporting capabilities, including an understanding of what metrics R& D Quality possesses, or can develop, that reflect the needs of Medical Governance & Affiliates operations
• Proactively identify trends influencing the companies overall compliance and propose monitoring and auditing tactics to further assess and evaluate trends
• Support monitoring and routine/ad hoc analysis and reporting
• Assist in providing day-to-day guidance, support and problem solving to internal stakeholders regarding monitoring and training issues
• Oversee monitoring, tracking, reporting, and communications to ensure compliance with required training Cross-functional Partner
• Support strategic partnerships with our cross functional stakeholders including Medical Affairs, Global Medical Strategy and Operations, Affiliates, Legal, Ethics &Compliance, and R D Quality
• Work collaboratively with other functional groups and relevant stakeholders, e.g., Regulatory Affairs and Patient Safety to advance the Medical Governance and Affiliate role as a Quality Business Partner
• Support the gathering of information necessary to escalate an issue of critical importance or controversy to the appropriate levels Medical Governance and Affiliates Compliance Culture
• Develop trusted relationships with Medical Affairs associates and Affiliate partners at all levels to promote an accountable complaint culture
• Assure completeness and currency of documentation that describe policy and process practices across Medical Affairs activities and Affiliates
• Promote a culture of quality, compliance and patient centricity Qualifications
• BA/BS with 3+ years relevant experience.
• Relevant experience in quality, compliance, governance and risk management in the biopharmaceutical or related industry
• Demonstrated critical thinking skills
• Familiarity with post-marketing medical affairs operations and activities
• General understanding of the PhRMA code regulations, standards, and business requirements
• Effective communication and interpersonal skills
• Excellent organizational and project management skills
• Demonstrated critical thinking skills and ability to define and implement quality and compliance constructs, standards, metrics, and practices that drive quality and compliance across cross-functional operations and activities
• Effective communication and interpersonal skills, to include developing relationships across organizational levels
• Excellent organizational and project management skills
• Previous people-management experience and a track record of effective leadership, whether through direct line or matrix team management Company Core Values
• Integrity (always doing the right thing)
• Teamwork (collaborating in good faith)
• Excellence (working at a high level of commitment and capability)
• Accountability (taking personal responsibility)
• Inclusion (encouraging diversity) Pay ranges between 53-63/hr based on experience