Sterility Assurance Lead

Job Title: Sterility Assurance Lead

*Only apply for this role if you have experience with sterility, contamination control and experience working with Annex 1*

About the Role:

We are seeking a proactive and experienced Sterility Assurance Lead to join our quality team at a leading biopharmaceutical manufacturing site. In this pivotal position, you will play a key role in ensuring all products manufactured meet the highest sterility and quality standards, supporting both marketed and investigational drug products. This role offers the opportunity to shape and drive contamination control and sterility assurance strategies while collaborating closely with both local and global teams across multiple functions.

Key Responsibilities:

• Take ownership of the site's Contamination Control Strategy, ensuring continuous improvement and compliance.

• Partner with Operations and Quality Control teams to design and deliver comprehensive training programs focused on aseptic processing and contamination prevention.

• Develop, implement, and oversee protocols for gowning, cleaning, and sanitization, working collaboratively with relevant stakeholders.

• Manage environmental monitoring and clean utilities programs to maintain strict sterility standards.

• Act as the subject matter expert on sterility assurance during audits, regulatory inspections, and cross-functional projects.

• Lead investigations related to contamination incidents and provide technical guidance on microbiological methods and transfers.

• Analyze microbiological data to identify trends and recommend risk mitigation strategies.

• Liaise with global scientific and technology functions to ensure site practices align with industry standards and regulatory expectations.

• Promote best practices in contamination control through ongoing training and active floor presence.

• Support continuous improvement initiatives and foster strong collaboration between quality and operations teams.

Qualifications and Experience:

• Bachelor's degree in Science or a related field (e.g., Chemistry, Microbiology, Biology); advanced qualifications in Microbiology are advantageous.

• 4-5 years' experience in pharmaceutical or biopharmaceutical quality or operations, preferably within a GMP environment.

• At least 1 year of experience in an aseptic sterile fill-finish manufacturing setting and 1 year in a microbiological role supporting such operations.

• Proven supervisory experience (2-5 years) with strong leadership and problem-solving skills.

• Ability to interpret microbiological data and implement effective corrective actions.

• Strong interpersonal skills to work effectively across departments and influence site teams.

• Comprehensive understanding of sterility assurance regulatory requirements and industry best practices.