Position Purpose:

The Pharmacovigilance & Regulatory Quality Assurance (PVRQA) Regional Lead is responsible for managing, maintaining, further developing and implementing scalable, globally aligned Pharmacovigilance & Regulatory Quality processes across Global Clinical Safety & Pharmacovigilance (GCSP), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA), Affiliates, Commercial Operations as well as other related interface departments on a regional level to ensure that CSLB’s entire Pharmacovigilance (PV) System is in compliance with applicable pharmacovigilance regulations and requirements, GVP, ICH GCP guidelines, respective GxP guidelines, international standards, relevant regulatory requirements and company policies.

The PVRQA Regional Lead is responsible for the ongoing operational support of existing PV Quality processes and systems across multiple departments like GCSP, GRA and GMA in the region. The primary business processes include, but are not limited to: Deviation and CAPA Management, Inspection Preparation and Management, Change Management, Continuous Improvement, Compliance, Governance and Reporting, 3rd Party Qualification and Management, Regulatory Intelligence, PV IT Systems and Procedural Quality Assurance. The position is also responsible for management of the Global PVRQA risk-based Audit Program in the respective region by planning, maintenance and timely execution.

This position is the direct contact partner for GCSP, GRA, GMA, Affiliate and Commercial Operations stakeholders in the respective region to provide support related to PV Quality and processes including provision of PV Quality training for the region to support continuous improvement.

Main Responsibilities and Accountabilities:

1. Provide GVP consultancy and other pharmacovigilance regulatory expertise in the Region to support the organization in maintaining required compliance:

• Provide GVP / local PV legislation and process related guidance and support
• Work with regional teams to investigate and resolve non-compliance, deviations and process related issues providing recommendations for solutions and CAPAs as needed
• Identification, definition and continuous assessment of key quality/performance indicators of the PV system in the Region; identification of key quality issues and escalation thereof to the Head PVRQA
• Ensure information about changes of/ updates of/ new PV legislation in the Region is distributed to relevant stakeholders, impact and gap analysis are performed by the functions as needed, any resulting actions are implemented to ensure continuous compliance with PV legislation
• Perform GVP review of new/ updated GxP relevant GCSP procedural documents as well as of PV relevant GRA/ GMA procedural documents, as assigned
• Collaborate cross-functionally in the Region to lead quality assurance training as appropriate for GCSP, GRA, GMA, affiliates and other respective interfaces and communicate best practices

2. Efficiently manage and oversee the regional PVRQA budget and head count aligned with global processes and forecasting expectations, including development/mentoring of auditors and support personnel.

Provide direction to regional auditors within Global PVRQA in the analysis of audit/ inspection observations, systematic problems and non-compliances.

3. Ensure efficient PVRQA presence in the region, including profound and efficient interfacing with stakeholder functions in relation to audit and inspection strategies as well as non-compliance trends.

4. Responsible for leading the Quality Assurance preparation, management and follow-up for all PV Health Authority inspections, GMP inspections which involve PV topics as well as 3rd party audits of CSLB’s PV system in the region:

• Lead preparation activities for inspections and audits; prepare inspection readiness plans, conduct training; conduct inspection readiness assessments/ mock interviews
• Analyze and communicate results and inspection preparedness to appropriate stakeholders and upper management
• Act as primary Inspection Coordinator during inspections, including direct interaction with inspectors in preparation, during conduct and follow-up of inspection, as assigned
• Support CSL affiliates in the region with PV audits and inspections
• Globally direct and actively support for-cause activities related to Pharmacovigilance, as needed.
• Support other regulatory authority inspections in all GxP areas, as required for Global Quality/ Global R&D Quality.

5. Lead and oversee the development, maintenance, execution and completion of the Global PVRQA Audit Program based on the long-term PV Audit Strategy in line with GVP Module IV (PVRQA audits of applicable global systems across GCSP, GRA, GMA and respective interfaces, affiliates and 3rd party vendors) in the Region:

• Responsible for risk assessments, input of information and tracking progress of the Regional Audit Program
• Manage auditor resource for the assigned region including external consultants
• Establish and track KPIs related to the audit program.

6. Analyze and report inspection and audit observations, gaps and systematic issues to relevant CSL management functions in order to improve processes within GCSP, GRA, GMA as well as affiliates, 3rd party vendors and other interfacing functions. Evaluate adequacy and completeness of CAPAs and effectiveness checks (ECs) originated from audits, inspections and/or deviations. Communicate and present summaries of inspection/ audit findings, trends, KPIs with recommendations to support continuous improvement as assigned.

7. Responsible for initial qualification of PV service providers in the Region, as well as other GxP service providers as they touch Pharmacovigilance. Ensure processes (including respective KPIs) are in place for a continuous quality oversight of all active service providers in the Region as well as maintenance of the respective qualified service provider list. 

8. Maintain and drive continuous improvement of Global PVRQA (processes, tools, etc.). Stay abreast of current quality and compliance regulations, guidelines, methodologies and trends, and implement or propose improvement initiatives in response.

9. Contribute ideas to the larger strategic vision of PVRQA and R&D Quality and interact with the respective Leadership Teams to ensure continuous alignment on vision.

10. Provide expertise across other GxPs to ensure coordination of overlap activities and to contribute to overall company compliance and synergies, as necessary.

11. Provide QA oversight of PV related BT systems as an integral part of CSLB’s BT QMS, as assigned.

Position Qualifications and Experience Requirements:

Education:

Minimum: Preferably, graduate degree in Scientific Discipline/ Life Sciences or related disciplines, or alternatively a bachelor’s degree and significant work experience as below.

Experience:

Minimum of 10 years of pharmaceutical industry or research/management experience, minimum 6 years’ experience in Pharmacovigilance Quality Assurance or other GxP Quality Assurance experience. Previous experience in managing or participating in regulatory inspections.

• Ability to think strategically and to quickly analyze complex circumstances and problems, and to drive appropriate decisions and actions
• Strong leadership role with experience in GVP or Pre-Clinical/GLP/GCP regulations and knowledge of international and national regulations and guidelines
• Excellent communication skills across all levels of the business
• Experience of working in global cross functional matrix teams
• Extensive understanding of GVP regulations and thorough knowledge of the drug development processes
• Experience in deviation and CAPA management processes
• Good customer focus, strong organization, communication (written and oral), influencing and negotiation skills
• Very good prioritization, organizational, communication, and negotiating skills
• Proficient in English
• Good computer skills, proficient in MS Office applications

Competencies:

• Enterprise Results and Value Orientation - Looks for outcomes that maximize the benefits for the Enterprise not just their department or function and pursues Value realization for the Enterprise even if their function does not benefit.
• Customer Orientation (external/internal) - Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs. Drives alignment across the Enterprise to customer needs.
• Collaboration & Influencing - Collaborates effectively with others and influences all stakeholders towards Enterprise outcomes, embracing the sometimes difficult conversations needed to deliver Enterprise value
• Strategic/Innovative – Exhibits global perspective. Takes a broad view when approaching issues. Sees ahead to future possibilities & translates to breakthrough strategies. Collaborates to influence strategies of others, and adapts own strategy towards Enterprise Value.
• Change Agent - Mobilizes others to initiate change; builds group momentum for change; embeds culture of change. Aligns change to Enterprise strategies and direction.