Audit Coordinator at GSK in Collegeville, PA

The Audit Coordinator is a member of the Quality Audit team part of R&D Quality and Risk Management. This role provides direct support to the Audit team for the resourcing across the GXP team and the operational management of outsourced audits. The role also includes responsibilities for supporting the onboarding of new contract auditors, providing access to internal GSK systems and ensures timely completion of training. The role involves effective liaising with contractor team/auditor and stakeholders for the confirmation and communication of the audit, tracking during the audit preparation, fieldwork and reporting. The role holder independently manages the tracking of internal and contracted audit timelines to ensure adherence to the audit schedule and reporting timelines.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

Coordinate creation of the audit program with the various teams
Coordinate resourcing across regions and GXP considering auditor competencies
Support maintenance of audit records and relevant information in audit management system
Develop and maintain communication with relevant stakeholders with regard to changes to the audit schedule.
Onboards contract auditors by ensuring completion and documentation of training prior to audit activities and providing access to systems to ensure valid access prior to audit fieldwork.
Liaises effectively with contract audit team and project managers as well as vendors to ensure audits are being scheduled on time and auditors are confirming audits with sites.
Support maintenance of audit records and relevant information in audit management system for outsourced audits, ensuring it is accurate and up to date.
Identifies and escalate issues during planning or audit fieldwork by contract auditors , including troubleshooting issues related to auditor access to relevant GSK and/or systems
Ability to ensure timelines for kick off meeting, audit fieldwork, feedback meeting and audit reporting are met.
Monitor the budget spend on outsourcing and routes PO and invoices.
Coordinate archiving activities.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

Bachelor's degree
Minimum of 2 years experience in Pharmaceutical industry

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

Experience in clinical research or development
GxP knowledge
Demonstrated ability to function effectively as team member; to communicate professionally and effectively, with all levels of management
Must have a high degree of organizational awareness
Have demonstrated project management skills and management of cross-functional activities
Have demonstrated ability for good verbal, written and presentation skills

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being.
Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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