Senior Quality Tech & Validation Manager

Regulatory Jobs; Pennsylvania; Vor Ort; USD 180.000 - 230.000; Vollzeit

Zusammenfassung

GSK is seeking a Quality Technical and Validation Manager to lead a team ensuring GxP compliance in validation/qualification of processes, equipment, and systems across manufacturing and analytical environments. The role interfaces with site leadership, GSK network, regulators, and drives New Product Introductions with robust change management.

The position requires a strong background in validation lifecycle management, regulatory knowledge (FDA/EMA/ICH), and leadership experience to enable

Qualifikationen

• Bachelor's degree in a scientific or engineering field is required.
• 10+ years in pharma/biotech with decision accountability.
• 5+ years of leadership experience.
• Experience in developing, approving, and executing process/equipment lifecycle programs and related docs.

Aufgaben

• GxP Oversight of Validation and Qualification Activities, ensuring GMP and regulatory compliance.
• Define phase-specific controls for production and lab value streams.
• NPI: oversee tech transfer reviews and approvals per regulatory standards.
• Develop/approve equipment validation protocols for facilities, utilities, equipment and systems including CSV.
• Determine change control requirements for validation/qualification activities.
• Ensure validation activities meet regulatory and quality standards.
• Collaborate with R&D, MSAT/validation, Product Quality Leads to accelerate product transfers.
• Monitor validation data to identify trends and opportunities for improvement.
• Participate in audits/inspections with expertise in validation and QA.
• Oversee lab applications, methodologies, and automation to meet CSV requirements.

Kenntnisse

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

Ausbildung

Bachelor's degree in a relevant scientific or engineering discipline

Advanced degree (Master's or Ph.D.) preferred

Tools

CSV validation software

Quality Management Tools

Jobbeschreibung

GSK is seeking a Quality Technical and Validation Manager to lead a team ensuring GxP compliance in validation/qualification of processes, equipment, and systems across manufacturing and analytical environments. The role interfaces with site leadership, GSK network, regulators, and drives New Product Introductions with robust change management.

The position requires a strong background in validation lifecycle management, regulatory knowledge (FDA/EMA/ICH), and leadership experience to enable