QA Validation & Sterility Assurance Associate Manager (all genders)

Your role:
As the Validation Compliance Lead, you will play a crucial role in ensuring compliance with all relevant regulatory requirements and internal policies related to cleaning validation, process validation, and sterility assurance. You will prepare for and actively participate in regulatory inspections and audits, ensuring our processes meet the highest standards. Your expertise will be essential in assessing and mitigating risks associated with validation processes, thereby safeguarding product quality and patient safety. You will oversee the review of validation documentation, ensuring accuracy and adherence to regulatory standards. Acting as the primary point of contact for validation-related inquiries, you will effectively communicate with both internal and external stakeholders. Your leadership will inspire and motivate a diverse team, fostering a culture of excellence in validation practices. By staying updated with industry trends and best practices, you will continuously enhance our validation processes. Your role is vital in maintaining our commitment to quality and compliance in all aspects of our operations.

Who you are:

• You hold a Bachelor’s degree in a relevant scientific discipline (e.g., Life Sciences, Engineering).
• You have proven experience in validation within the pharmaceutical or biotechnology industry, particularly in sterility assurance and cleaning/process validation.
• You possess strong leadership and team management skills, with the ability to inspire and motivate a diverse team.
• You have in-depth knowledge of regulatory requirements (FDA, EMA, etc.) and industry standards related to validation and sterility assurance.
• You demonstrate excellent problem-solving skills with a strong analytical mindset to assess validation processes and identify improvements.
• Your verbal and written communication skills are exceptional, allowing you to convey complex information clearly to various audiences.
• You can work collaboratively across departments and with external partners to achieve common goals.
• You are committed to continuous professional development and staying updated with industry trends and best practices.