Senior Manager, Medical & Affiliates, R&D Quality

Official Job Title: Senior Manager, Medical & Affiliates, R&D Quality
Location: Parsippany, NJ (hybrid)
PR: $65 - $68.33

Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your pharma business expertise to partner with internal teams and external partners as we strive to cure unmet medical needs?

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 Client.

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 Clients 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

Client 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)

About Client R&D Quality and Medical Governance & Affiliates
Client R&D Quality and the Medical Governance & Affiliates team is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team.
We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.
We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.
Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?