Sterility Assurance Senior Expert

GSK; Barnard Castle; On-site; GBP 80,000 - 100,000; Full time

Job summary

A global pharmaceutical leader is seeking a Sterility Assurance Facility Manager to oversee sterility assurance projects and ensure compliance with regulatory standards. This role involves leading contamination control strategies, collaborating with cross-functional teams, and driving the implementation of sterility assurance measures across facilities. Candidates should have a Bachelor's degree in a relevant scientific field and significant experience in sterility assurance in the pharmaceutical industry. The position offers a competitive salary and an annual bonus.

Benefits

Competitive salary

Annual bonus based on company performance

Healthcare and wellbeing programmes

Pension plan membership

Shares and savings programme

Qualifications

• Bachelor's degree in a relevant field.
• Significant experience in sterility assurance within the pharmaceutical industry.
• Strong knowledge of regulatory requirements and industry standards.

Responsibilities

• Lead sterility assurance projects ensuring compliance with regulations.
• Monitor performance metrics and implement corrective actions.
• Act as a primary point of contact for sterility assurance.

Skills

Regulatory knowledge (FDA, MHRA, EMA)

Problem-solving

Leadership

Project management

Attention to detail

Education

Bachelor's degree in Chemistry, Biochemistry, Microbiology

Job description

We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

The Sterility Assurance Facility Manager leads sterility assurance projects and has overall oversight of facilities within their areas of responsibility, ensuring compliance with regulatory requirements and industry standards. This role drives contamination control strategies (CCS), ensures the implementation of sterility assurance measures across site facilities, and collaborates with operations to ensure the consistent application of sterility assurance requirements.

In this role you will

• Lead sterility assurance projects to ensure contamination control strategies (CCS) are effectively implemented and aligned with site objectives and regulatory requirements.
• Provide overall oversight of facility operations, ensuring compliance with sterility assurance standards and contamination control measures.
• Drive the implementation of sterility assurance programmes across facilities, collaborating with cross-functional teams site and above site teams to ensure consistency and effectiveness.
• Ensure facilities are maintained and operated in alignment with industry best practices, regulatory requirements, and contamination prevention principles.
• Collaborate with operations and quality teams to ensure contamination control measures are integrated effectively into manufacturing processes.
• Monitor performance metrics related to facility operations and contamination control, identifying areas for improvement and implementing corrective actions as needed.
• Act as the primary point of contact for sterility assurance within facilities, representing the team during audits, inspections, and internal reviews.
• Contribute to the harmonisation and continuous improvement of sterility assurance practices across the organisation, sharing knowledge and best practices.
• Develop and deliver training programmes, ensuring staff understand and consistently apply sterility assurance and contamination control measures.
• Support the strategic planning and execution of facility upgrades or projects to optimise contamination control systems and ensure regulatory compliance.

Basic Qualifications & Skills

• Bachelor's degree in Chemistry, Biochemistry, Microbiology, or a related field
• Significant experience in sterility assurance within the pharmaceutical, biotechnology, or related industry
• Strong knowledge of regulatory requirements around sterility assurance and sterile manufacturing (e.g., FDA, MHRA, EMA) and industry standards (e.g., cGMP, ISO).
• Excellent problem‑solving skills and attention to detail.
• Strong leadership and project management abilities.
• Effective communication and interpersonal skills.

Preferred Qualifications & Skills

• An advanced degree in Chemistry, Biochemistry, Microbiology, or a related field provides advanced knowledge of the scientific principles and methodologies that are crucial for ensuring product quality in the pharmaceutical industry.

Closing Date

16th December 2025 (COB)

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.