Director PVQA, APAC

Director PharmacoVigilance Quality Assurance (PVQA) - APAC

Location : Singapore

Department : R&D PV QA

Reporting to : Head of Global PVQA

Territory : Asia Pacific

Travel % : up to 30%

ABOUT THE BUSINESS

Our client is a global pharmaceu8cal company with more than 100 years of scientific expertise and specializes in developing oncology and cardiovascular drugs providing innovative products and services around the world.

QUALIFICATIONS

Education

• Bachelor's Degree in Life Sciences, Pharmacy or Medicines required

• Master’s Degree, preferred

• PhD or advanced degree in Life Sciences, Pharmacy or Medicines preferred
  

Work Experience

• 10 or more years of involvement in regulated activities, PharmacoVigilance, QA (preferably) and clinical development leadership positions; broad understanding of global expectations of Health Authorities in the area of Clinical Development; profound understanding of the science of product development preferred.

• Demonstrated experience and broad understanding of Pharmacovigilance, post marketing studies and post approval safety studies (PASS).

• 10 or more years of demonstrated accomplishments in a global/matrix environment in the pharmaceutical industry.

• Must have expertise in leading/managing (Global) projects and Clinical Safety or Pharmacovigilance activities

• Must possess strong leadership, interpersonal, communication, negotiation and problem-solving skills.

• Must have ability to work independently and in a team environment.

• Demonstrated experience and proven track record of successfully leading projects with high impact.

• Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors. Preferred

- Considerable organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross- functionally and in global teams.

• Strong industry network in clinical development. Knowledge and understanding of cultural differences and diversity issues.

• Strong written and oral communication skills (English).
  

Competencies

• Profound knowledge of global drug development

• Demonstrated experience of successfully supporting projects of high impact

• Demonstrated agility in a global/matrix environment

• Strong interpersonal skills with demonstrated ability to build collaborative relationships

• Strong project management skills

- Thorough and extensive knowledge of ICH-GCP including FDA/EU regulations, pharmacovigilance, new drug regulations, other key HA guidance’s and current industry practice- Excellent verbal and written communication skills and computer skills.

• Excellent problem solving and decision-making skills. Skilled at conflict resolution/negotiation

• Capable of working independently as well as part of a cross functional team demonstrating the ability to influence and create alignment across multiple functional areas

• Flexibility to react to changing priorities in a dynamic business environment

• Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams across different regions of the world
  

RESPONSIBILITIES

Customer Focus / Regulatory Inspections (30%)

• 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 (30%)

• 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 (20%)

• 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 management at the program level

• Provide leadership and guidance during the development and execution of Corrective and Preventive Actions (CAPAs) including tracking of timely closure, proper effective checks and adequate and timely escalation of critical issues.

• Partner with QMS QA to ensure aligned implementation of all applicable Quality Standards in CSPV and identify appropriate con%nuous improvements initiatives of quality and compliance

related areas.

• Lead effective communications within the CPV teams, by interacting with other GxP QA functions (GMP/ IMP QA, Audit and Compliance, Quality Management Systems QA)

• Collaborate with regional PV QA leaders to ensure strategic alignment across geographic regions and drive continuous process improvements
  

External Engagement (10%)

• Continuously review and analyze compliance trends from regulators and industry experts to align the CSPV roadmap with evolving regulatory and business needs.

• Ensure robust knowledge transfer and continuous process improvement based on audits, inspections, and risk management.

• Cultivate relationships with external partners, collaborators, and vendors to foster a culture of compliance
  

Strategy (10%)

- Contribute to the strategic direc8on of the global PV QA function, working with the Head of Global PV QA to shape the mid- and long-term PV QA strategy.

- May deputize for the to Head of Global PV QA to shape the strategic direction of the global PV QA function based on the organization’s mid-term plan and beyond- Ensure adequate PV quality resource are in place in the APAC and align strategy for the APAC PVQA with the global PV QA strategy that is closely linked to the global R&D & PV QA strategy across regions and geographic areas.

• Contribute to the strategic road map, metrics, dashboard, and project management methodologies to lead an efficient and effective organization

• Support the global quality annual objectives, strategic initiatives to deliver against the business plan.

• In close collaboration with PV QA regional leaders in Japan, EU, Americas, create PV QA strategy in close collaboration with the Head of Global PV QA