Director Pvqa

**Responsibilities**:
Customer Focus / Regulatory Inspections
- Provide quality oversight for Oncology and Specialty Medicine portfolios, aligning with the business strategy.
- Support the implementation of the quality strategy, tracking progress on Quality Manual breakdown into an actionable annual Quality Plan, Monitor progress of the Quality plan including risk assessments and inspection readiness activities.. Ensure proactive representation of Quality professionals at strategic non-project team and at CSPV strategic discussions as assigned.
- Lead inspection management activities by ensuring continued submission, compliance and inspection preparedness for the respective PV inspections in alignment with regulatory and company strategy specifically within the APAC region
- Act as PV QA management representative for key health authority inspections in the APAC region (China FDI, Taiwan FDA, etc.). Develop and maintain an effective working relationship with US FDA and other international bodies such as China-NMPA, Taiwan FDA etc.
- Lead and/or manage license partner audits, and Represent PV QA at relevant strategic discussions and ensure safety risks are identified and mitigated
- Ensure timely and effective implementation of Corrective and Preventive Actions (CAPAs) during inspections, license partner audits.
- Ensure adequate CAPAs are defined, implemented, and closed by providing guidance and facilitation of quality event resolution.
- Proactively ensure that all functions consistently operate in a state of compliance.
- May be tasked as a QA reviewer to support/ lead the review of the safety section of the dossier for regulatory submissions in collaboration with the Audit and Compliance team.
- Take the lead as the Head of PV QA APAC to ensure that APAC topics, risks, respective product profile targeting APAC population are addressed from a PV QA standpoint and represent QA at governance meetings where QA is necessary.
- Support Head of Global PV QA to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs). Collaborate with Global QA teams in the Americas, Tokyo, Europe and Brazil to ensure relevant quality monthly reports are delivered in a timely manner. Ensure that safety risks are duly identified, mitigated in collaboration with the business functions. Identify appropriate continuous improvement initiatives for quality and compliance related areas.
- May Deputize for the Head Global PV QA at Leadership teams, as appropriate and as needed.

Oversight
- Provide strategic direction for PVQA for CSPV activities, collaborating with global project teams, safety management teams, medical affairs, and external partners like CROs.
- Ensure that PV QA oversight is integrated into key CSPV activities and that quality risks are proactively managed.
- Collaborate with global teams and stakeholders to maintain high data quality and ensure issues are detected and resolve
- Ensure adequate and timely escalation of incidents/issues within CSPV. Provide Quality oversight for deviations/incidents investigations, and ensure that adequate CAPAs are defined, implemented and their closure tracked.
- Ensure that proper Quality oversight is implemented for 3rd parties/vendors/outsourced activities.
- Provide oversight over the implementation of CAPA effectiveness checks. Share quality status information to business functions is a timely manner at appropriate forums), including the support of creating and reviewing quality metrics for the Quarterly Quality Report (QQR) and Quality Review Boards (QRBs).
- Support business process owners directly in ensuring quality is integrated in all stages of process development.
- Ensure Business Stakeholders are educated on common deviations/QI’s to reduce volume, based on proper planning and execution and to build a stronger quality organization.
- Implement and lead the process to regularly review and assess KQIs and prepare respective management documentation for the Head, Global PVQA for review at the Quality Leadership level and CSPV Leadership level/ governance teams. Ensure that potential gaps and risks are addressed and opportunities for continuous improvement identified.

Leadership and Team Management
- Manage talent and performance of direct reports; ensure adequate succession planning
- Foster a high-performing team environment with a culture of integrity, respect, and continuous quality improvement.
- Lead and hold direct reports accountable to performance, talent and development objectives
- Create an environment that fosters diversity of thoughts, inclusivity and one that adheres to the principals set forth in the organization (JOIN, GROW, THRIVE)
- Drive performance management, mentoring, and professional development for the PV QA team.
- Cultivate an inclusive, innovative environment that aligns with organizational values.
- Collaborate across CSPV teams to ensure proactive quality risk mana