Quality Unit Business Process Specialist - Drug Substance

Regulatory Toolkit; Pennsylvania; On-site; USD 85,000 - 110,000; Full time

Job summary

GSK in the United States is seeking a Quality Unit Business Process Specialist to support drug substance operations. You will collaborate daily with manufacturing, quality, IT and engineering to ensure compliant quality processes and SOPs are maintained.

You will oversee quality systems, identify improvement opportunities, coach colleagues, and drive documentation practices while contributing to continuous improvement and readiness for regulatory audits.

Qualifications

• Bachelor's degree and 3+ years in a regulated life sciences setting.
• Experience designing or supporting quality business processes and SOPs.
• Strong understanding of GMP, GDP, and regulatory requirements.

Responsibilities

• Provide quality oversight for drug substance processes and systems, ensuring compliance and acting as a quality contact across sites.
• Support investigations, root cause analysis and CAPA for quality deviations.
• Facilitate risk reviews and train site colleagues on quality processes and documentation.

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

Education

Bachelor's degree in life sciences, engineering, quality, or a related technical field

Tools

SAP ERP

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 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.

Position Summary:

Join us as a Quality Unit Business Process Specialist supporting drug substance operations at a United States site. You will collaborate daily with manufacturing, quality, IT, and engineering teams to ensure quality processes run smoothly and compliantly. Your role will focus on overseeing quality systems, identifying improvement opportunities, and coaching colleagues to maintain high standards. We value practical problem-solvers who know how to communicate clearly and take ownership. This role offers visible impact, continuous learning, and career growth as you contribute to our mission of uniting science, technology, and talent to get ahead of disease together.

Responsibilities:

• Provide quality oversight for drug substance-related business processes and systems, ensuring compliance with regulations and internal standards. Act as a key quality contact for cross-functional teams and sites on master data, process changes, and procedural questions. Develop, review, and maintain quality unit business process documentation and standard operating procedures (SOPs).


• Support investigations, root cause analysis, and corrective and preventive actions related to quality deviations and process issues.


• Facilitate quality impact assessments and risk reviews for process and system changes. Train and coach site colleagues on quality processes, documentation practices, and compliance requirements.

Basic Qualifications:

• Bachelor’s degree in life sciences, engineering, quality, or a related technical field. Minimum 3 years’ experience in cGMP production, quality control, or quality assurance in a regulated life sciences environment. Experience designing, implementing, or supporting quality business processes, preferably involving SAP or similar ERP.


• Practical knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and regulatory compliance. Experience participating in change control, CAPA, deviations, or quality investigations. Strong verbal and written communication skills and ability to work collaboratively on-site with cross-functional teams.

Preferred Qualifications:

• Experience in pharmaceutical or biologics manufacturing environments, particularly with computerized manufacturing systems. Familiarity with laboratory information management systems (LIMS), Manufacturing Execution Systems (MES), or electronic batch records.


• Formal training or experience in structured root cause analysis and risk assessment techniques. Proven ability to influence and coach colleagues at different levels and from multiple disciplines. Experience maintaining inspection readiness and supporting regulatory audits. Demonstrated focus on continuous improvement through monitoring of quality metrics and KPIs.

Work Arrangement:

This role is on-site at a United States manufacturing location with regular presence required in production and laboratory areas. Hybrid or remote work is not available.

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.

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.

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