QA Validation & Sterility Assurance Associate Manager(m/w/x)

Description

Cleaning and process validation for sterility assurance at healthcare manufacturer with 60,000+ employees. Leadership experience in FDA and EMA regulated pharmaceutical environments required. 30 days vacation, hybrid work model.

Requirements

• •Bachelor’s degree in relevant scientific discipline
• •Experience in pharmaceutical or biotechnology validation
• •Strong leadership and team management skills
• •Knowledge of FDA and EMA regulations
• •Excellent problem-solving and analytical mindset
• •Exceptional verbal and written communication skills
• •Ability to work collaboratively across departments
• •Commitment to continuous professional development

Tasks

• •Ensure compliance with regulatory requirements and internal policies
• •Manage cleaning validation, process validation, and sterility assurance
• •Assess and mitigate risks in validation processes
• •Safeguard product quality and patient safety
• •Prepare for and participate in regulatory inspections
• •Support and manage internal and external audits
• •Oversee the review of validation documentation
• •Ensure accuracy and adherence to regulatory standards
• •Act as the primary contact for validation inquiries
• •Communicate effectively with internal and external stakeholders
• •Lead and motivate a diverse validation team
• •Foster a culture of excellence in validation
• •Monitor industry trends and validation best practices
• •Continuously enhance internal validation processes

Tools & Technologies