Description
We are seeking a Quality Technical and Validation Manager to join our team. As a key member of the site quality leadership team, you will be responsible for ensuring the highest standards of GxP compliance in the validation and qualification of processes, equipment, and systems within GSK's manufacturing and analytical environments.
Responsibilities:
- Provide GxP oversight of validation and qualification activities
- Determine phase-specific controls and ensure their adherence for production and laboratory value streams
- Provide quality oversight and approval of technology transfer activities for new product introductions
- Develop, review, and approve equipment validation protocols
- Determine change control requirements, including for validation and qualification activities
- Ensure that all validation activities are current and conducted in accordance with GSK's quality standards, regulatory requirements, and industry best practices
- Work with enterprise partners to identify, evaluate, and initiate strategies to rapidly develop product transfers
- Monitor and analyze validation data, identifying trends and areas for improvement
- Participate in internal and external audits and inspections
- Oversee laboratory business applications, methodologies, and automation
Basic Qualifications:
- Bachelor's degree in a relevant scientific or engineering discipline
- 10+ years of experience in the pharmaceutical or biotechnology industry
- 5+ years of leadership experience
- Experience in developing, approving, and executing process and equipment lifecycle management programs
Preferred Qualifications:
- Advanced degree in a relevant scientific or engineering discipline
- Strong skills to identify business requirements and provide solutions to complex issues
- Strong knowledge of regulatory requirements and industry standards for validation and quality assurance
- Certification in quality assurance or validation
- Experience with continuous improvement methodologies
Benefits:
- Comprehensive benefits program, including [insert benefits]
We value diversity and inclusion in the workplace. We are committed to creating an environment where all employees can thrive and focus on what matters most.