Description
Join GSK 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.
Responsibilities:
- Provide quality oversight for drug substance-related business processes and systems, ensuring compliance with regulations and internal standards.
- 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.
- Practical knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and regulatory compliance.
Preferred Qualifications:
- Experience in pharmaceutical or biologics manufacturing environments, particularly with computerized manufacturing systems.
- 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.
Benefits: GSK offers a comprehensive benefits program, which can be found at GSK US Benefits Summary.
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