Quality Technical and Validation Manager

OneWe Reach; Northern (KY); Hybrid; USD 140,000 - 200,000; Full time

Benefits offered by this job

Benefits program

Job summary

GSK seeks a Quality Technical and Validation Manager to lead validation and qualification activities across processes, equipment and systems in a GMP environment. You will partner with R&D, MSAT and QA to drive continuous improvement and ensure regulatory compliance.

The role requires deep expertise in validation lifecycle management, NPI tech transfers, and robust change control. You will adapt to regulatory inspections and mentor site teams to achieve GxP excellence.

Qualifications

• Bachelor's degree in a scientific or engineering field required
• 10+ years in pharma/biotech, decision accountability
• 5+ years in leadership
• Experience with process/equipment lifecycle programs and related protocols/reports

Responsibilities

• GxP oversight of validation and qualification activities across processes/equipment/facilities
• Determine phase-specific controls for production and lab value streams
• NPI: approve tech transfer tasks to ensure regulatory compliance
• Develop/approve equipment validation protocols for facilities, utilities, equipment, and systems including computer systems
• Determine change control requirements for validation/qualification activities
• Ensure validation activities align with quality/regulatory standards and best practices
• Collaborate with R&D/global MSAT/validation to enable rapid product transfers
• Monitor validation data to identify trends and drive improvements
• Participate in audits/inspections as validation/QA expert
• Oversee laboratory applications and CSV requirements

Skills

GxP Regulations

Leadership

Quality Assurance

Problem Solving

Education

Bachelor's degree in a relevant scientific or engineering discipline

Advanced degree preferred

Tools

CSV (Computer System Validation)

QMS (Quality Management Systems)

Job description

Business Introduction

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

This key member of the site quality leadership team has a responsibility and accountability of a team that ensures the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within GSK's manufacturing and analytical environments. The role is both inward facing to the site, and outward facing to the GSK network and as an SME to regulators during regulatory inspections. They are pivotal in overseeing new product introductions (NPI) and associated manufacturing and analytical activities, ensuring seamless introduction of products from and to other supply nodes. Using robust change management practices, they ensure compliance with process, equipment, and computer system validation lifecycle activities, to ensure systems meet regulatory and quality requirements. Doing so ensures compliance with GSK and Regulatory Standards as they apply to Validation and Process Lifecycle Management.

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

• GxP Oversight of Validation and Qualification Activities. Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines in the validation and qualification of processes, equipment, and facilities.
• Determine phase specific controls, and ensure their adherence, for the production and laboratory value streams
• New Product Introduction (NPI): Provide quality oversight and approval of technology transfer activities to ensure adherence with GSK and regulatory standards. This includes review and approval of process and analytical tech transfer tasks and protocols.
• Develop, Review and approve equipment validation protocols for all facility services, utilities, equipment, laboratory equipment and systems including computer systems.
• Determines change control requirements, including for validation and qualification activities.
• Ensure that all validation activities are current and conducted in accordance with GSK's quality standards, regulatory requirements, and industry best practices.
• Work with enterprise partners (R&D, global MSAT/validation, Product Quality Leads) in identifying, evaluating and initiating strategies to rapidly developing product transfers by developing a partnership with the business areas to which they are aligned.
• Monitor and analyze validation data, identifying trends and areas for improvement.
• Participate in internal and external audits and inspections, providing expertise on validation and quality assurance matters.
• Oversee laboratory business applications, methodologies, and automation to ensure they meet quality and compliance standards including their respective Computer System Validation (CSV) requirements.

Why you?

Basic Qualifications:

• Bachelor's degree in a relevant scientific or engineering discipline (e.g., Chemistry, Biology, Pharmacy, Engineering).
• 10+ years of experience in the pharmaceutical or biotechnology industry, responsible/accountable for decisions and their outcomes.
• 5+ years of leadership experience.
• Experience in developing, approving, and executing process and equipment lifecycle management programs (Continued Process Verification, Validation Master Plans, etc.), and their underpinning protocols and reports.

Preferred Qualifications:

• Advanced degree (e.g., Master's, Ph.D.) in a relevant scientific or engineering discipline.
• Strong skills to identify business requirements and to provide solutions to complex issues
• Strong knowledge of regulatory requirements (e.g., FDA, EMA, ICH) and industry standards for validation and quality assurance.
• Certification in quality assurance or validation (e.g., ASQ, ISPE).
• Experience with continuous improvement methodologies (e.g., Six Sigma, Lean).

What we value

We create a welcoming work environment where people can do their best work. We commit to inclusion and to helping colleagues grow. We want people who work with integrity, show respect, and who learn and adapt. If you are ready to take ownership of meaningful projects and help us improve how we serve patients and customers, we would like to hear from you.

Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical Writing

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail]

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.