Quality R&D Labs Analytical Operations Lead

Site Name: USA - Pennsylvania- Upper Providence, USA - Pennsylvania- King of Prussia

Posted Date: Jun 19 2025

Are you a quality professional looking for a challenging opportunity to ensure quality oversight and adherence to GMP standards within the Analytical Development team, supporting GMP analytical activities at GSK manufacturing sites? If so, this could be a great position to explore.

Join GSK as a Quality R&D Labs Analytical Operations Lead where you will organize and provide Quality Oversight, coaching and guidance while maintaining inspection readiness to ensure compliance to GMP standards and procedures through independent oversight of GMP processes. You will be responsible for ensuring laboratory operations comply with GMP standards, as well as local, corporate, and applicable international regulations. You will promote a culture of continuous improvement and compliance. This role will support quality oversight at our Upper Merion, Upper Providence and our Marietta sites.

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

• Organize oversight planning, conduct spot-checks, review documentation for adherence to ALCOA++ principles, and provide coaching to build a strong understanding of quality requirements.
• As a Compliance Authority, you oversee deviations, CAPAs, and change controls within AD GMP, ensuring compliance, timely resolution, and approval of controlled documents such as SOPs, reports, analytical methods.
• Manage and escalate issues appropriately to ensure timely and effective resolution in collaboration with Analytical Development teams.
• Promote a "Quality Starts With Me" (QSWM) mindset, coaching employees on the importance of compliance in safeguarding product quality and patient safety, while driving the harmonization of quality standards and streamlining processes to enhance efficiency.
• Collaborate with Analytical Development and Quality R&D teams to ensure quality practices are fit-for-purpose and aligned with R&D objectives.
• Provide a unified Quality voice, utilizing a risk-based approach.
• Contribute to shared quality activities at the site level, such as facilitating audits, and support both local and global QR&D initiatives, including the implementation of the R&D Quality Management System (QMS).
• Ensure inspection readiness and compliance by preparing for and supporting internal audits and external inspections.
• Provide proportionate quality input to processes and systems to effectively manage risks.

Why you?

Basic Qualifications:

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

• Bachelors degree plus 8+ years of experience in a quality or compliance role within the pharmaceutical or biotechnology industry, with a focus on R&D.
• Strong experience in (clinical) release required considering the diversity of the analytical and manufacturing of clinical vaccines.
• Analytical R&D expertise.
• Proven experience in quality activities in an R&D environment, including but not limited to audit facilitation and quality system implementation, deviation/ investigation, documentation management, training, change control, CAPA, product disposition, and/ or validation.

Preferred Qualifications:

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

• Excellent oral, written communication skills and ability to coach and explain.
• Ability to coach, mentor and train.
• Strong interpersonal skills with an ability to enable and drive change.
• Problem identification and solving skills.
• Deep knowledge in quality regulation requirements covering GMP and general quality compliance.
• Ability to manage networks and build relationships transversally across the network. Experience of working with multi-functional teams.
• Flexible thinking and risk-based approach methodology adept.
• Ability to adapt, work under uncertainty and accommodate flexible work demands

#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.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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