Quality Unit Business Process Specialist - Drug Substance

GSK•Marietta, PA

12d•Onsite

About The Position

The Quality Unit Business Process Specialist supports drug substance operations at a United States manufacturing site. Working daily with manufacturing, quality, IT, and engineering teams, the specialist helps ensure quality processes operate smoothly and comply with regulations and internal standards. The role oversees quality systems, identifies opportunities for improvement, and coaches colleagues on quality practices. It is an on-site position requiring regular presence in production and laboratory areas; hybrid and remote work are not available.

Requirements

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.

Nice To Haves

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.

Responsibilities

Provide quality oversight for drug substance-related business processes and systems, ensuring compliance with regulations and internal standards.
Serve 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.