Site Name: USA - Pennsylvania - Upper Providence, USA - Pennsylvania - King of Prussia
Posted Date: May 19 2023

Are you energized by a highly specialized technical role that leverages the latest in quality analytical technology and method development? If so, this Operational QA Manager role could be a great opportunity to explore.

As an Associate QA Director, you will have an Opportunity to join a global Quality Assurance team responsible performing internal audits of GMP functions and activities performed at all US and UK Pharma R&D sites as well as third party audits associated with GMP facility and equipment service providers. This role allows an individual to be empowered to drive global harmonization and efficiencies, define and implement program improvements, and provide expert advice on regulatory requirements. The role also provides exposure to a variety of R&D activities including clinical manufacturing, packaging and labeling of clinical supplies, analytical testing, Third Party Management, validation, calibration and maintenance, etc.

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

• Provide general QA oversight and consultancy in regard to regulatory expectations to reduce regulatory risk to GSK.
• Establish improvement processes, as needed, or set specific measurable targets and goals linked to the audit program
• Review and approve internal and external audit reports.
• Lead external audits of third parties who provide GMP services for facility and equipment in Pharma R&D sites.
• Author audit reports including risk-based findings.
• Lead internal audits according to the defined Pharma R&D audit universe and schedule, including assessment planning, report authoring and close-out. Support the ongoing update of the audit universe in line with emerging issues or changes to regulatory expectations.
• Liaise with customers to provide compliance advice/input, including providing input in support of Quality Councils across the R&D business.
• Identify and mitigate compliance risks to GSK through effective audits.
• Represent the group as a primary business contact for specific areas.
• Make recommendations for corrective and preventative actions using established Root Cause Analysis.
• Build and maintain effective internal GSK business relationships within Pharma R&D GMP QA and business units.
• Provide support to multiple projects of high priority including regulatory inspections and high-risk non-compliance issues.
• Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices.
• Communicate and interact at various levels internally and externally to GSK.
• Proactively identify, communicate, and monitor business changes that could impact on quality or compliance within the department and across departments.

Why you?

Basic Qualifications:

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

• 7 plus years' experience in Pharma quality assurance or a quality-focused role
• Bachelor’s degree in scientific or health care discipline

Preferred Qualifications:

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

• Able to prioritize and decide appropriate course of action.
• Broad knowledge of the R&D drug development process/pharmaceutical industry
• Experience leading and managing internal and external audits.
• Able to interact with peers, subordinates, and senior personnel in a multidisciplinary environment.
• Strong verbal and written communication skills
• Strong interpersonal skills
• Experience defining or managing an audit program.
• Knowledge of facility and equipment calibration and maintenance programs and requirements
• Experience with root cause analysis
• In-depth knowledge of GMP areas and regulations

#LI-GSK

#globalsupplychain

#vaccinessupplychain

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 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.

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

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 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.

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 GSK’s Transparency Reporting For the Record site.