Internal Audit Lead

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

The job holder will manage the site Self Inspection and Internal Audit Programs. They will provide guidance to the site in the area of cGMP compliance and manage communications to site for regulatory inspections. They will also own the Inspection Readiness Program at site.

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

• Complete Audit Certification (ACP) Training and receive certification.
• Acts as a Certified Lead Auditor during Upper Merion internal audits.
• Generates and obtains approval for audit plan on an annual basis. Holds meetings as required to review audit plan, as well as holding meetings to review and explain audit findings with designated members of management.
• Issues internal audit reports using existing format. Reviews responses for adequacy and communicates discrepancies with responses to owners. Assists owners as required with responses to internal audit observations.

• Ensures all internal audits are responded to in a timely fashion as defined in the audit report, and tracks progress to ensure audit commitment dates are met on time. Generates and publishes monthly report for outstanding internal audit commitments. Performs follow-up for responses to ensure corrective actions as committed are implemented.

• Assists in the preparation for and participation in regulatory agency inspections, corporate and customer audits. Performs audit observation follow-up for global quality assurance audits and regulatory inspections as requested.
• Manages the site Self Inspection Program.
• Collect and compile data for Site Quality metrics and quality related trending within required timeframes

Why you?

Basic Qualifications:

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

• BS or BA degree
• 5 years of sufficient technical depth or professional experience will be considered in lieu of technical degree such as Lab, Manufacturing or quality experience in a GMP environment with 2 years of experience in the pharmaceutical industry.
• 2 Pharmaceutical industry experience
• 1 year of audit experience

Preferred Qualifications:

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

• Thorough technical and regulatory knowledge of current pharmaceutical manufacturing techniques and the applicable current regulatory and GSK requirements.
• Developed auditing skills: developing and executing an audit plan, preparing and using checklists, following-up, documenting findings, etc.
• Certification as a Quality Auditor is desirable.
• Excellent verbal / written communication and interpersonal skills: respect for people, sensitivity to cultural differences, active listening, succinct writing, decision-making ability, objectivity, and assertiveness.
• Solid ethics and Integrity: confidentiality, impartiality, independent, straightforward, and sensitivity to problems.

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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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.
#LI-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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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