Quality Technical and Validation Manager

GlaxoSmithKline; United States; On-site; USD 110,000 - 130,000; Full time

Job summary

A leading pharmaceutical company in the United States seeks a Quality Technical and Validation Manager. This role requires 10+ years of experience in the pharmaceutical or biotechnology industry, focusing on compliance with quality standards. Responsibilities include overseeing validation and qualification activities, managing change controls, and ensuring adherence to regulatory guidelines. The ideal candidate must hold a Bachelor's degree in a relevant scientific discipline and demonstrate strong leadership capabilities. Join us to make a significant impact in delivering high-quality medicines and vaccines.

Qualifications

• 10+ years in pharmaceutical or biotechnology industry.
• 5+ years of leadership experience.
• Experience with process and equipment lifecycle management.

Responsibilities

• Ensure compliance with GMP and regulatory guidelines.
• Provide oversight for technology transfer activities.
• Develop and approve validation protocols.

Skills

GxP Oversight

Quality Oversight

Change Control Management

Validation Protocols

Data Analysis

Education

Bachelor’s degree in Chemistry

Master’s or Ph.D. in relevant discipline

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.

Job Overview

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.

Responsibilities

• 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.
• Determine 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) to identify, evaluate and initiate 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.

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.

How to Apply

Ready to take the next step? Apply now to join our team and help deliver projects that make a real difference.

Benefits Summary

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Contact for Adjustments

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us at [e-mail] where you can also request a call.

Equal Opportunity Employer Statement

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.

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.

Additional Notice

Please note that if you are a U.S. 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 U.S. Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/.