Job Purpose
The Team Lead is responsible for developing and delivering a robust audit program within the scope of R&D. This position will develop methods to effectively and efficiently design and deliver the audit strategy. This position will manage a team responsible for conducting all types of independent audits of External Service Providers and Internal GSK processes globally. The purpose is to ensure compliance with relevant international regulatory agency regulations/guidelines, GSK policies/procedures, including the Internal Control Framework and accepted principles. The Team Lead will work with the other roles in R&D Quality and Risk Management across the matrix, build solid working relationships with the stakeholders and maintain knowledge of regulatory frameworks and requirements.
Key Responsibilities
Team and Performance Management:
* Manage and develop a team of Auditors, ensuring the delivery of a risk-based audit program that meets regulatory authority requirements leveraging different audit types.
* Recruit, train, and coach staff, addressing their development needs and ensuring their performance aligns with organizational goals.
* Oversee administrative aspects such as budget and personnel administration.
Audit Program Delivery:
* Provide strategic input in the development, management, and implementation of strategies and initiatives, policies and procedures to support the audit program.
* Lead the planning, coordination, and execution of audits across central processes, Local Operating Companies and External Third Parties.
* Provide strategic vision and leadership oversight to sponsor or lead cross functional projects.
* Ensure process and risk-based audit approach and clear documentation of audit findings.
* Monitor appropriate metrics to oversee critical audit activities.
Compliance and Quality Assurance:
* Generate and interpret metrics and trend reports to identify trends and opportunities for improvements across the business.
* Collaborate with stakeholders to interpret international regulations and establish compliance standards.
* Provide expert advice on complex compliance issues, quality improvement initiatives, and risk assessments.
* Represent GSK at global regulatory inspections.
Stakeholder Engagement:
* Build and maintain beneficial working relationships with internal and external customers and across the Matrix in R&D Quality and Risk Management.
* Accurately and clearly communicate about audit, inspection, and investigation trends. Educate, guide, and influence stakeholders on best quality and compliance practices, especially in areas of identified responsibility.
* Proactively communicate audit outcomes, findings and complex issues to VPs and SVPs, working with them to remediate identified issues.
Regulatory and Industry Awareness:
* Maintain an up-to-date and in-depth knowledge of national and international legislation and guidelines.
* Analyse external regulatory intelligence and influence internal change as required.
* Develop, maintain and leverage a network of external contacts with other quality and compliance industry bodies.
Why you?
Basic Qualifications:
* Bachelor’s degree in Life Science, Pharmacy, Health Science, or related discipline.
* Proven ability to lead and influence teams, demonstrating GSK Leadership Expectations.
* Broad scientific/pharmaceutical industry background with experience in the relevant Regulatory area.
* Extensive knowledge of global, regional, and national regulatory requirements and regulations.
* Self-motivated quick learner who shares knowledge and welcomes feedback.
* Proven ability to influence and negotiate with senior stakeholders.
* Demonstrated project management skills and management of complex cross-functional activities.
Preferred Qualifications:
* Experience in supporting regulatory authority inspections.
* Advanced Scientific Degree (PharmD, PhD).
* Broad knowledge of Risk-based quality management, root cause analysis, and quality by design concepts and methodology.
* Digital savviness, experience with AI/ML and data analytics.
* Excellent verbal, written, and presentation skills.
* Ability to work independently and make decisions with minimal supervision.
* Excellent interpersonal skills, and ability to work in the matrix across geographical and organisational boundaries.
* Ability and desire for frequent domestic and international travel (approximately 25%).
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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