GlaxoSmithKline Looking for Internal Auditor at Zebulon, NC  Full Time

Are you looking for an Internal Auditor role that allows you to leverage your technical knowledge in a manufacturing GMP environment? If so, this Quality Internal Auditor role could be an ideal opportunity to explore.

As an Internal Auditor, you will be responsible to Manage the site Management Monitoring and Independent Business Monitoring (IBM) Audit Programs. Define activities necessary to bring the site to a state of continued inspection readiness. Provide guidance to the site in the area of cGMP compliance. Handle the coordination of CAPAs for DEV investigations. Manage the Periodic Product Review (PPR) process.

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

• Acts as Auditor during Zebulon Independent Business Monitoring 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 IBM reports using existing format. Reviews responses for adequacy and communicates discrepancies with responses to owners. Assists owners as required with responses to IBM observations.

• Ensures all IBM 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 IBM 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 Management Monitoring Program.

• Acts as a student of current regulatory expectations and provides consultation to customers on interpretation of regulation and guidance published by regulatory agencies, industry and GSK.

• Participate in applicable root cause analysis teams to review and agree to the CAPA plan, the CAPA performance measures and the assessment dates. Coordinates CAPAs and verifies that applicable CAPA has been delivered as committed and that the CAPA remains “in place” and “in use”. Monitor and review performance measures to ensure CAPA effectiveness.

• Manages the Periodic Product Review (PPR) Program for the Site. Compiles the contributor data and processes each PPR within VQD for approval.

• Collect and compile data for Site Quality metrics and quality related trending within required timeframes.

• Maintains a program that ensures the sites inspection readiness status is held, reviewed and updated as required in line with changes in business and regulatory requirements.

• Responsible for the issuance, GMP review, and archiving of paper logbooks for the Zebulon site.

Why you?Basic Qualifications:

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

• Bachelor’s degree in pharmacy, Science, Technical or an engineering discipline, OR equivalent level of knowledge, understanding and hand on experience of Good Manufacturing Practices in the pharmaceutical environment.

• 6+ years of Manufacturing/Quality experience in the pharmaceutical industry.

• Experience with the application of Quality Systems in manufacturing, warehousing and distribution.

Preferred Qualifications:

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

• Master’s Degree

• 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

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, rigor 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.

About the Zebulon Site

GSK’s Zebulon site is a global supplier of Respiratory and Solid Dose medicines to patients around the globe and the largest GSK Pharmaceutical secondary manufacturing site in North America. The site is located less than 30 minutes from downtown Raleigh, Wendell, Knightdale, Rocky Mount, Wilson, and Wake Forest.

Key differentiators about GSK and Zebulon:

* Our commitment to inclusion and diversity – we see diversity as a critical advantage of ours

* Our focus on cultivating a positive work environment that cares for our employees

* Demonstrated opportunities for continued career growth driven by individual ambition

* Leaders that care about their teams and growth of both individuals and the company

* A priority focus on Safety and Quality

* Clean and GMP compliant work environment

* Onsite cafeteria

* Onsite gym

* Temperature-controlled climate

* Licensed, onsite Health & Wellness clinic

* CDC, local and federal compliant with COVID-19 mandates

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

Why Us?

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 positively impact the health of 2.5 billion people by the end of 2030.

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.

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