Associate Director, Quality Auditor

Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Mar 18 2025

The purpose of this role is to provide independent Quality Assurance within GSK R&D by delivering comprehensive audit programs. This role will define audit scope and methodology to conduct audits and ensure the delivery of audit reports. This role involves identifying compliance issues, trends within the scope of R&D to ensure compliance with relevant international regulatory agency regulations/guidelines, GSK policies/procedures and accepted principles and improving overall processes. Additionally, the role includes supporting QA activities during regulatory inspections, building solid working relationships with stakeholders, and maintaining knowledge of local regulatory frameworks and global regulatory reporting requirements.

The role occupant (employee) is primarily aligned to preclinical Good Laboratory Practice (GLP) & secondarily with Good Clinical Practice (GCP) laboratoties and is suitably qualified by training and/or experience to perform the relevant QA responsibilities as outlined in this job description.

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

Functional Expertise:
? Lead in the development, management, and implementation of strategies, and initiatives to support global quality assurance audit programs.
? Partner within the R&D Quality and Risk Management team to develop and deliver the risk strategy for the annual audit plan.
? Independently manage comprehensive quality assurance programs and assess adherence to quality standards and compliance with international regulations and guidelines, and GSK policies and procedures.
? Independently plan, lead, and conduct different complex audit types of GSK processes and third parties to assess compliance with applicable regulations and guidelines, and GSK policies and procedures.
? Document objective and process-oriented audit findings in audit reports, and present findings to relevant stakeholders.
? Ensure robust CAPAs are obtained that address the findings, and their root causes.
? Lead functional initiatives as assigned.
? Ability to lead key process improvement initiatives from design to implementation and continuous improvement.
? Generate and interpret metrics and trend reports to identify trends and opportunities for improvements across the business.
? Act as inspection coordinator for related regulatory authority inspections of GSK.

Collaboration:
? Collaborate with stakeholders to interpret international regulations and guidelines, and Regulatory Intelligence to establish and monitor compliance for (GSK) acceptable standards relating to audit activities.
? Provide expert advice in several areas of expertise on compliance, quality improvement initiatives and risk assessments.
? Educate, guide, and influence stakeholders on best quality and compliance practices, especially in areas of identified responsibility.
? Responsible for training and providing feedback to peers as well as coaching and mentor junior staff.
? Maintains the highest level of awareness, expertise in international relevant regulations, and internal policies and SOPs.
? Expert knowledge of relevant processes and procedures at a level that can ensure 'Big Picture' solutions and strategies
? Constantly considers new technical skills and emerging technologies, and how they apply in processes in R&D
? Has developed and utilized a network of external contacts with other quality and compliance industry bodies
? Actively compares and considers peer and external implementations of quality procedures in GSK.
? Ability and desire for frequent domestic and international travel (approximately 25%)

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
? Bachelor?s degree in scientific or quality-related field.
? 5+ years' experience in pharmaceutical industry and/or quality assurance.
? 8 + years' expertise in GLP and GCP laboratory regulatory requirements.
? Experience in risk management, specifically as it applies to audit management and oversite of R&D areas and third parties.
? Experience in developing learning tools utilizing new technology or concepts.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
? Experience in leading regulatory authority inspections.
? Experience and knowledge covering two or more Regulatory area e.g. GCP and GLP.
? 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.
? Proven excellent verbal, written communication and presentation skills.
? Excellent interpersonal skills, and ability to work in the matrix across geographical and organizational boundaries.
? Demonstrated analytical, organizational and planning skills.

#LI-GSK

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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK?s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Apply Job!