The Director, Asia Pacific Risk Management will enable corporate R&D objectives through risk management and quality planning across the Asia Pacific and China R&D by partnering with relevant operations and business partners. Under the general direction of the Head of Quality Planning & Strategy, this person is responsible for the development and execution of a quality framework to proactively identify and in collaboration with business partners support the development of mitigation activities for R&D risks and significant quality issues that may have an impact on approval or acceptance of health authority submissions, and/or general compliance to company and industry standards and national and international regulations
Main responsibilities will include, but are not limited to:
- Manage the development and maintenance of an integrated quality strategy to support AP and China R&D business-critical activities and compliance
- Drive QP&S quality oversight strategies in the ASPAC region to ensure effective risk management and mitigations are in place across the region.
- Work with risk owners across the region to develop effective risk mitigation plans to control risks identified
- Provide input into integrated quality plans (IQPs) (when requested) and ensure that issues identified from AP region are built into IQP risk mitigation plans.
- Lead or assist in the early identification, escalation, and resolution of quality issues that pose a significant risk to achievement of core company objectives
- Proactively liaise with BRQC relevant strategy leaders to share issues identified in the AP region /China R&D and assure outcomes of key mitigation activities are communicated to relevant stakeholders, including management (as applicable)
- Work with BRQC Janssen QA domain leaders to share issues in the region and support the development of an audit schedule to address areas of key risk
- Collaborate with Regulatory Compliance to support inspection readiness activities to facilitate health authority submissions
- Develop and execute pre-inspection readiness activities for internal Janssen R&D and external parties as directed by the AP Strategy Lead
- Support GCP inspections in AP region including post-inspection commitments as assigned
- Contribute to 90-day risk mitigation plans following closure of a deal to license or acquire a product to support development of mitigation strategies and provide relevant information to the QP&S L&A Lead as requested
- Leverage quality analytics data, internal and external factors and contextualized key quality insights to provide quality consultancy to primary stakeholders
- Influence the regulatory environment in China/AP by commenting on key regulations in China/AP region, and engagement with external stakeholders in the development and interpretation of new regulations where appropriate.
- Resolves compliance/regulatory issues with business leaders within AP and China R&D. Must be able to work independently to determine risk level and make decisions about proper mitigation of risk to ensure submission success. Must have a firm understanding of the risk management process to mentor colleagues and to develop and maintain effective quality plans. Must have strong analytical skills to interpret a high volume of data, in collaboration with cross-functional partners, and capture insights and make decisions based on interpretation
- Will work independently to drive effective risk management and enable successful inspection readiness. He or she will seek guidance from the AP Strategy Lead and act with a sense of urgency to manage priorities. He/she will independently liaise with cross-functional partners on a continual basis to support key R&D initiatives and inspections in the region. He/she is expected to lead and be proactive in setting and maintaining priorities to achieve BRQC Janssen and Janssen R&D goals and objectives
Principal Relationships Inside the Companies:
- Must be able to effectively operate in a matrix environment and influence and interact with key stakeholders on a regular basis. The ability to simultaneously meet business needs and functional objectives is required. He/she will be expected to maintain a strong network of peers across BRQC Janssen and the greater J&J Quality and Compliance organization, to coordinate activities related to the clinical operations integrated quality strategy and ensure connection to surrounding systems and activities that may impact the effectiveness or value of the quality strategy. He/she will have contact with individual employees, management and peers across Janssen R&D, including Medical Safety, Regulatory, R&D and clinical operational organizations, therapeutic areas, finance, law, and supply chain organizations
Principal Relationships Outside the Companies
- May interact, as appropriate, with quality, R&D, and medical safety professionals in third-party organizations, marketing partners, and health authority officials as needed. He or she will create business relationships with industry peers.