Site Name: GSK HQ, Upper Merion, Upper Providence

Posted Date: Jun 24 2024

Location: GSK HQ (London)

Other locations can be envisaged: US/UK/EU

Job Purpose

The primary purpose of this job is to assist GSK manufacturing sites in highly regulated markets to be inspection ready every day via consultancy and assessment. This role is responsible for working with sites to apply processes associated with inspection readiness and to assist them during GMP inspections by major regulatory authorities (e.g., US FDA, UK MHRA, EMA, Irish HPRA, China FDA) and, as needed, following regulatory authority inspections to assist in the preparation of responses to any findings from the authorities.

Key Responsibilities:

• Using a risk-based approach, assisting sites with their inspection readiness but conducting pre-inspection readiness activities, incluidng pre-inspection assessments, mock inspections, review of presentations on hot topics and coaching of fronters likely to interact with the regulatory inspectors during the inspection.

• Preparation of clear and objective assessment reports to inform senior management of any inspection readiness risks and to create the opportunity to implement appropriate corrective action plans to address any such risks.

• During inspections, provide support (e.g. Subject Matter Expert coaching, Control Room and Inspection Room Support)

• Post inspection, actively participate in the response writing process (if the inspecting authority issues findings), create and circulate assessments regarding the implications, if any, of inspection findings for other sites in the network and, where conducted, participate in after action reviews.

• Verify CAPA completion for findings from key regulatory inspections in advance of the next inspection by the same regulatory authority.

• Propose updates to GSK's global Quality Management System and or local site SOPs based upon gaps in inspection readiness

• Expand knowledge base at highly regulated sites through proactive knowledge sharing and collaboration.

• Promote excellence and continuous improvement associated with inspection readiness best practice and processes.

• Participation in the Inspection Readiness Community of Practice

Why You?

Knowledge/ Education / Experience Required

Educational Background

Minimum Level of Education:

• BA/BS degree or equivalent in experience

Area of Specialisation:

• Chemistry, pharmacy, biological sciences, chemical engineering or science related

Preferred Level of Education:

• BA/BS or Master Degree

Minimum Level of Job-Related Experience

• Good knowledge of world-wide cGMPs, regulatory requirements, standards and Quality Management Systems for pharmaceuticals, APIs, biopharmaceuticals, medical devices, steriles. Minimum 10 years experience preferred.

• Proficiency and preferably a minimum of 10 years experience in identifying regulatory inspection risks.

• Broad based familiarity with primary, secondary manufacturing, and sterile manufacturing.

• Good knowledge of the pharmaceutical industry current best practice in analytical and manufacturing technologies, engineering practices, validation and cGMP compliance

• Understanding of and experience in following corporate governance processes

Other Job-Related Requirements

• Ability and willingness to travel at short notice

• Flexibility at all times

• Up to 50% travel over the course of each year

When applying for this role, please download your CV in English + a cover letter to describe how you meet the competencies for this role.

Closing Date for Applications - July 15th

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.

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