External Quality Lab Director

Nazwa biura: USA - Pennsylvania - King of Prussia, Durham Blackwell Street, UK - County Durham - Barnard Castle, UK - Hertfordshire - Ware, UK – London – New Oxford Street, USA - Maryland - Rockville
Posted Date: Nov

At GSK, we manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance.
Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Are you looking for an opportunity to lead and shape the quality standards for laboratory activities in external manufacturing? This role offers the chance to make a meaningful impact by ensuring the highest quality standards are met across our external network. You will collaborate with cross-functional teams, influence external partners, and contribute to GSK's mission of uniting science, technology, and talent to get ahead of disease together. Join us to grow your career while making a difference in the lives of patients worldwide.

The purpose of this role is to provide leadership in the quality and compliance of laboratory services provided by external partners, including external laboratories, third-party service providers (TP), and contract manufacturing organizations (CMO's). The External Quality Lab Director is fully accountable for ensuring compliant and efficient service for all external third parties based in their remit. The role actively participates in the development and execution of the quality strategy for the GSK external third-party network. This role includes leadership of a team focused on the quality management of the third parties. This position involves building strong partnerships with external laboratories, conducting audits and reviews, and driving continuous improvement initiatives to safeguard product quality and patient safety. It requires both technical expertise in laboratory operations and strong leadership skills to manage a team and external relationships.

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

• Management and development of an empowered team with necessary skills to support the current and future business.
• Ensuring Quality Oversight provided by the team is fully aligned with GSK expectations( Quality, Compliance, Supply), Good Laboratory Practices and global regulatory requirements  -  specifically on these activities:
  • Method Validation and Verification
  • Method performance Analysis
  • Analytical Inspection Readiness Oversight - Review Inspection Readiness plans and support implementation and assessment activities. Monitor mitigation of inspectional risks and escalate as necessary
  • CMO/TP methods and Specifications Compliance
  • Analytical batch release and CoA generation when required.
  • CMO/TP Investigations - Resolution, mitigation or rapid escalation of issues impacting product Quality, safety and efficacy.
  • LIC/PIRC support for analytical topics
  • CMO/TP Stability program oversight
  • Nitrosamines testing oversight
• Development and delivery of a quality strategy for the assigned network in close collaboration with Central QC Team.
• Evaluate and qualify external laboratories and third-party service providers through rigorous audits and assessments.

Why You?

Basic Qualifications
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree with 10+ years of experience in laboratory operations, quality assurance, or analytical testing within the pharmaceutical or biopharmaceutical industry
• Experience within quality systems (QA) and quality control processes
• Experience with analytical methods, validation processes, and laboratory management systems
• Experience within GLP and GMP environments 
• Experience working with regulatory requirements

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

• Post graduate degree (MS or PhD)
• Good understanding of GXP's and data integrity principles.
• Capable of managing across boundaries
• Excellent influencing and negotiating skills
• Excellent verbal and written skills – English
• Strategic thinking and decision-making capabilities
•  Proven ability to manage teams
• Demonstrated ability to develop and coach staff

This role offers a hybrid working model, providing flexibility to balance remote and on-site work.

We encourage you to apply if you are passionate about quality, collaboration, and making a difference in healthcare. Join us in our mission to improve lives and get ahead of disease together.

The US annual base salary for new hires in this position ranges from $163,350 to $272,250 The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.

If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

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 purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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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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