Director Head PV QA (APAC)

POSITION SUMMARY:

This position operationally reports to the Global Head PVQA and will have direct reports across APAC region. This individual is a member of the global PV QA leadership team. The position may also represent quality in other cross functional leadership teams such as R&D, CSPV, Medical Affairs, Corporate Compliance and any other LT as assigned.

This position is accountable to drive the standardization and process improvement initiatives across PV Quality and in close collaboration with internal and external stakeholders. This position supports the vision and strategy for the Global Pharmacovigilance (PV) quality strategy in close collaboration with the business units and other QA functions. Ensures a fit for purpose global PV QA organization by ensuring that processes and procedures are compliant with applicable Pharmacovigilance regulations (GvP) and requirements, ICH GCP guidelines, international standards, relevant regulatory requirements and company policies for Asia Pacific.

Maintain knowledge with current industry trends, Health Authority expectations and influence standards accordingly to incorporate into business processes.

Define/introduce and implement improvements to existing tools and operationalize new systems in support of overall process excellence in Global QA. This position supports global strategy across the enterprise in line with the strategic mission and vision of the global quality organization. Other support functions includes collaboration with R&D quality, Audit and Compliance, Medical Affairs Quality, GMP /GDP to ensure that activities are conducted in compliance with applicable regulations as applicable to critical PV systems.

A strategic thinker, with the capability to interact cross functionally and manage day- to day- operations of the group through leadership and effective interaction / influential skills in Asia Pacific. Ensures direct reports are engaged, empowered and effective performance management of team. Ability to effectively interact across boundaries (globally and regionally) to engage cross –functional teams both within Global Oncology Business unit, Specialty Medicine, Clinical Operations, Regulatory affairs, CSPV, and other cross functional teams as necessary. Ability to demonstrate effective leadership capabilities in a changing and growing environment. Committed to the values of integrity, accountability, transparency, leadership rigor and drive necessary for the success of the assigned function. May be tasked to deputize Global Head PV QA on critical and important business matters.

Manage Asia Pacific PV QA resource in an efficient and effective manner including but not limited to oversight of defined work products, coaching and mentoring of team, performance management and contributing to organizational efficiencies.

RESPONSIBILITIES:

Customer Focus:

Develop/support best-in-class Global PV QA organization by refining existing practices, and developing the PV quality strategy that supports the interface of PV and Medical affairs.

• Lead/ Collaborate with cross functional leaders across the company to drive standardization of best practices in the PV area.
• Proactively ensure that all functions consistently operate in a state of compliance. Ensure effective collaboration with CSPV teams.
• Assess / Address redundancies both within QA and in CSPV, specifically for PV quality and compliance team in CSPV.
• Takes an active leadership role in ensuring that PV QA expertise is consistently provided to the CSPV functional area to support the organization in sustaining GVP compliance; Provides GVP and process related guidance and support.
• Works with teams to investigate and resolve non-compliance, deviations and process related issues.
• Attends relevant meetings where PV QA input is required e.g. compliance monitoring, and support all aspects of the Global PV Audit Program to ensures successful execution of auditing, deviation management, CAPA management and vendor management related to the Pharmacovigilance system.
• Ensures consistency in approach and reporting of PV audits in Asia Pacific through establishment of monthly PV QA review
• Lead and present at the monthly PV/MA quality council to present PV summaries of audit findings, trends, KPIs with recommendations to support continuous improvement.
• Provide oversight of the qualification and ongoing management of Pharmacovigilance service providers including maintenance of the PV qualified service provider list in Asia Pacific.
• Ensure adequate oversight for risk assessments for input of information and tracking as necessary.
• Act as management representative for key health authority in Asia Pacific, specifically where PV is in question. Develop and maintain an effective working relationship with relevant HAs and other international bodies.
• Ensure end to end compliance cycle SOP-Training- Metrics/Trending- Lessons learned to drive meaningful customer experience.

Oversight:

Support Global PVQA strategic direction pertinent to the Systems, Processes, Procedures for internal QA team (global/ local), but also to:

• Medical Affairs (Oncology Business unit, Specialty Medicine BU, Japan BU and ASCA BU)
• Global Project Teams
• Global Clinical Operations team
• Clinical Safety and Pharmacovigilance
• Companion Diagnostics/ Device
• Vendors/ CROs

Review of Pharmacovigilance Agreements/ Safety Data Exchange Agreements to ensure agreements are in compliance with regulatory and company requirements. Collaborates with PV Operations or other Business Support role to manage process and compliance related issues. Ensure adequate inspection management for PV inspections across Asia Pacific countries.

Further ensure proper quality oversight and escalation of issues / incidences specifically as it relates to the support functions impacting the QA teams such as 3rd parties/vendors/outsourced activities.

Support the implementation the of an enhanced self-assessment/self-inspection process.

Contributes to quality overview, metrics, trends, impacting the business portfolio:

a. Global Safety Board

b. External Alliance Committee

c. Quality leadership team

d. Develop/ chair or co-lead quality council as necessary.

Leadership/ team management:

• Create a high performing team environment and a cohesive culture driven by values of integrity, respect, and culture of speak up
• Lead and hold others 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)
• Create an environment that thrives on innovation, proactive quality and is disciplined to efficiently execute against pre-defined deliverables
• Drive employee engagement, mentoring, coaching and performance management
• Exhibit servant leadership while drivingresults.

External Engagement:

• Contribute, help shape the associated external regulatory environment through participation in industry wide organizations to assure the needs of the company are proactively established and that innovative approach to solutions are in place
• Continuously review compliance metrics trends from regulators/ industry experts and align develop the PV QA road map to meet changing regulatory and business needs.
• Lead remediations and risk management to assure the organization’s critical PV systems are periodically reviewed, assessed and continuous process improvement is in place.
• Drive effective relationship with alliance partners, collaborators, vendors, and other key company partners to ensure a culture of compliance at all levels

Strategy:

• Support the strategic direction of the global PV QA on the organization’s mid-term plan and beyond for Asia Pacific.
• Ensure adequate resource are in place.
• Effectively manage budget on strategic projects assigned.
• Create and maintain 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.

EDUCATION AND EXPERIENCE

EDUCATION Undergraduate and Graduate Degree is required

EXPERIENCE AND KEY COMPETENCIES

• Previous experience at a senior management level leading a QA GCP/ PV / MA QA organization and demonstrated track record of successful results
• Significant experience in managing many aspects of quality in an international, global context in a regulated health care environment
• Experience in Pharmaceuticals, Medical Device, Vaccines, Diagnostics, Generics/ Consumer products,
• Strong expertise in continuous improvement, change management, and evolving the capabilities of an organization.
• Experience working directly with global Health Authorities (FDA, EMA, MHRA, CFDA, PMDA MFDS) and other government and local agencies.
• Working knowledge of the end-to-end Drug development process (manufacturing to commercialization).

LEADERSHIP COMPETENCIES

• Building relationships and Promoting Collaborations- Develop and maintain open and honest relationship with others. Provide constructive feedback and develop others to succeed and achieve goals.
• Leading with Courage- Takes accountability of owns action and decision, relentless in doing what’s right for patients and the organization, support others who do so, challenges the status quo and strive for continuous improvement.
• Results Driven and Execution- Demonstrate a strong sense to achieve goals through commitment and effective execution of work process
• Focus on Stakeholders/ Customers: Collaborate and work closely with stakeholders/ customers to understand their needs and expectations
• Global business acumen- Understand, develops, and promote effective quality and regulatory process across various countries and coordinate appropriately with global business expectations
• Build and inspire Trust- Gains others’ trust through servant leadership and sound business ethics
• Sound Judgment- Solves problems and applies analytical approach to arrive to decisions
• Developing People and Talent- Taking time to identify, develop and evaluate talent, assure priority is placed on needed talent and their strength meets company expectations
• Influential- Gain stakeholder commitment, effective relationship building and conflict management, present compelling case for ideas and initiatives through thoughtful strategy to gain a favorable outcome.
• Think Strategically- Takes any role or job and drive a better outcome; a change agent, desire to focus on value creation, driven to envision a better future, desire improves processes and does not allow complacency.