QU Program Manager

GlaxoSmithKline - Marietta, PA

Full-time - Mid Level

Marietta, PA

Chemical Manufacturing

About the position

The QU Program Manager will lead the development and management of strategic areas within the Quality Unit at the Marietta Site. This role focuses on Governance, Operational Excellence, Quality Risk Management, Project Oversight, and Continuous Improvement, providing opportunities for career progression through key activities and responsibilities.

Responsibilities

• Lead and ensure GPS implementation across the Quality organization.
• Maintain overview of all projects within the Quality Unit and assist QU PMs with PMO preparation.
• Mentor others on project planning, including financial and resource allocations, monitoring and tracking project status.
• Develop and track relevant project KPIs and communicate progress, risk, and issues.
• Act as the Risk Management champion for the Quality Unit, leading QU Risk meetings.
• Review meeting structure within the Quality Unit to ensure appropriate governance is in place.
• Write and update the Site Quality Plan.
• Collaborate with Global functions and other GSK sites to share best practices and maintain visibility on relevant initiatives.
• Partner with Quality Systems to define and deliver actions aimed at improving Quality indicators.
• Facilitate sessions to drive a culture of continuous improvement using lean tools.

Requirements

• Bachelor's Degree in Microbiology, Biology/Virology, Biochemistry, Chemistry, Pharmacy or relevant technical discipline.
• 5+ years experience in Quality Assurance or Quality Control within clinical or commercial organizations.

Nice-to-haves

• Versed in GMP's, NIH Guidelines, FDA and other regulatory agency requirements.
• Prior experience with licensed biopharmaceutical or biological products.
• In-depth experience in quality systems, including validation and compliance.
• Strong communication and problem-solving skills.
• Certification or training in quality systems or cGMP compliance by a recognized organization.
• Knowledge of Risk Management Principles and Techniques.
• High learning agility and analytical skills.

Benefits

• Comprehensive benefits program including health insurance, retirement plans, and paid time off.