Drive strong quality oversight and implementation of robust risk management strategies across the portfolio
Develop and manage Integrated Quality Plans (IQPs) to support business-critical activities such as health authority submissions to support new molecular entities or new indications for use.
Execute quality oversight activities as per the IQP plan and work with risk owners across R&D functions to develop effective risk mitigation plans to control risks identified in the IQP.
Provide input to trial oversight and quality strategies to ensure that issues are identified in the IQP and mitigated early, and that predefined risk mitigation plans in the IQP are executed in a timely fashion and are effective in mitigating the risk to an acceptable level.
Lead quality working groups (QWGs) to define and refine the IQP. Organize and lead meetings of the QWG to periodically assess quality metrics to determine if risks are adequately defined and controlled under the IQP. Communicate outcomes of QWG meetings to relevant stakeholders including senior management.
Lead or assist in the early identification, escalation, and resolution of significant quality issues that pose a significant risk to achievement of core company objectives.
In collaboration with Regulatory Compliance, lead inspection-readiness activities to support health authority submissions. Develop and execute pre-inspection readiness activities for internal Janssen R&D and external parties that contribute to regulatory submissions.
May manage site Inspections as well as Sponsor Monitor Inspections outside the three major inspectorates (FDA, EMA, MHRA). Support inspections managed by Regulatory Compliance.
Leverage quality analytics data and contextualize key quality insights to primary stakeholders and provide quality consultancy. Consult/collaborate with other BRQC functions to harness the single point of contact model to our business partners.
Consult with appropriate BRQC business partners and peers to provide guidance or review and approve Corrective and Preventative Action Plans (Self-Identified, Inspection). May also develop Corrective and Preventative Action Plans.
Collaborate with external development partners for joint clinical quality oversight as per clinical quality agreements.
Provide regular status reports to BRQC management.
Resolve compliance/regulatory issues with business leaders within the Therapeutic Area (TA)/Disease Area Stronghold (DAS).
Lead cross-functional teams to determine risk level and make decisions about proper mitigation of risk to ensure submission success.
Participate in/lead QP&S, cross-BRQC Janssen, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that support key activities.
Train/mentor others with regard to teamwork, interpretation of regulatory requirements, risk management, and compliance activities.
Lead both functional and cross functional workstreams and initiatives, embedding innovative strategies
Collaboration with Cross Therapeutic Area functional leads to establish oversight and drive consistency in processes and practices
Recruitment and hiring of cross TA talent
A Bachelor’s degree is required, advanced degree is preferred. Degree concentration in a scientific, medical, or related discipline is preferred. Experience working in a medium- to large-scale matrix organization that includes applicable compliance-related healthcare field (i.e., pharmaceutical, medical device, healthcare/hospital system) and/or equivalent time and experience in a related regulated R&D area is required. Knowledge of the drug development process and global GxP compliance regulations, sound research and development practices, scientific and quality terminology, company quality assurance procedures and policies.
Ability to interpret data to develop executable action plans to improve business
Strong personal leadership with demonstrated competency interfacing with all levels of the organization including senior leaders
Strong networking and relationship-building skills
Ability to create an open and inviting environment and embraces generational differences
Exceptional written and verbal communication skills and good knowledge of English is required.
Experience in R&D process requirements to successfully drive Q&C productivity, strategy optimization, process improvements and efficiencies including development and management of CAPA and facilitation of Root Cause Analysis
Ability to motivate professional colleagues and stakeholders
Conflict resolution/management and negotiation skills
Ability to independently plan, organize, coordinate, manage and execute assigned tasks
Strong working knowledge of ICH-GCP and country-specific regulations and guidelines related to clinical development
Experience with regulatory submissions (NDA, BLA)
Proficient in Microsoft Office applications (Office, Teams, PowerPoint, Word, Excel)
Experience collaborating in a cross-functional team environment
Experience of key customers’ business processes and practices is an asset
A high degree of accuracy and attention to detail and commitment to quality
Flexibility to respond to changing business needs
Preferred experience includes:
Experience with fundamentals of clinical trial risk management
Experience in Quality Management and Compliance functions
Strong project management skills
Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related)
Ability to analyze and interpret collective data to provide insights to drive decision making
Inspection support experience (FDA, EMA, and other inspectorates/health authorities)
Negotiation and influencing
Proactive strategic thinker
Ability to create an open environment
Up to 25% primarily domestic and/or international travel