GSK
Research & Development Quality Operations Specialty Lead
USA - Pennsylvania - Marietta · Hybrid (Remote & On-site) · Full-time · Posted Oct 12, 2026
- Experience
- Minimum 5 years in Quality in a highly regulated environment and minimum 5 years in pharmaceutical, biologics, regulated manufacturing, or quality roles.
- Education
- Bachelor’s degree required in scientific, engineering, pharmacy, or related discipline.
About the job
Leads operational quality activities across R&D manufacturing and supplier partners to protect patient safety, maintain compliance, and support reliable product supply.
What you'll do
- Approve GMP documentation and lead investigations, root-cause analyses, and corrective and preventive actions.
- Oversee quality systems, audits, regulatory inspection readiness, and compliance risk assessments.
- Provide quality leadership for manufacturing partners and coach teams to improve processes and compliance.
What they ask for
- Bachelor’s degree in a scientific, engineering, pharmacy, or related discipline.
- At least 5 years of experience in Quality in a highly regulated environment.
- At least 5 years of experience in pharmaceutical, biologics, regulated manufacturing, or quality roles.
- Fluency in written and spoken English; experience with cGMP, quality systems, GMP documentation, and aseptic manufacturing activities.
Nice to have
- Quality oversight experience with external suppliers or contract manufacturers; familiarity with regulatory inspections.
- Experience with data trending, root-cause analysis tools, statistical methods, or coaching operational quality teams.
Tools
cGMP, FDA, EU, WHO, GMP, CAPA
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