Sterility Assurance Lead (Associate Director)

Role Summary

Sterility Assurance Lead (Associate Director) at a King of Prussia, PA site. Leads sterility assurance programs to ensure sterility and quality across manufacturing processes, collaborating across teams to maintain compliance with regulatory standards and advancing patient health through quality and innovation.

Responsibilities

• Be the key contact for all matters related to Sterility Assurance including Aseptic Practices, Environmental monitoring plans, Surface Cleaning and Sanitization, Sterilization, Media Fill and Sterility Failures; provide expert support to production, engineering and QA.
• Coordinate the team to define and maintain microbiological environmental and aseptic operator monitoring plans, microbiological monitoring plans for utilities and other samples, and execute media fills for initial validation and re-validation.
• Coordinate, organize and execute other validation activities such as biovalidation, facility and utilities validation.
• Maintain and ensure aseptic procedures are in place and in use.
• Support investigations where aseptic assurance is at risk.
• Project support for aseptic assurance; oversight of microbial control strategy.
• Be an active member of the aseptic quality network; manage cost center.
• Ensure the structure is appropriately sized and foster the development of team members' skills.
• Promote a collaborative and stimulating work environment; encourage professional growth through training, feedback, mentoring, and coaching.
• Ensure risk assessments, risk communication, and action planning are completed per the Risk Management System within the relevant business area.

Qualifications

• Required: Bachelor‚Äôs degree in Microbiology, Biology, Chemistry, or related scientific field.
• Required: Minimum of 5 years of experience in sterility assurance or aseptic manufacturing in pharmaceutical/biopharma/biotech space.
• Required: Experience with regulatory inspections and audits.
• Required: Experience with aseptic techniques and cleanroom operations.
• Preferred: Advanced degree in Microbiology, Biology, Chemistry, or related field.
• Preferred: Leadership experience within sterility assurance or quality assurance.
• Preferred: Knowledge of risk assessment tools and methodologies.
• Preferred: Familiarity with validation processes for aseptic manufacturing.
• Preferred: Strong problem-solving, analytical, and communication skills; knowledge of regulatory requirements for sterility assurance (FDA/EMA); ability to lead investigations and implement corrective actions.

Skills

• Strong collaboration and cross-functional communication
• Leadership and people development
• Risk assessment and management
• Aseptic technique and cleanroom operations
• Investigation and corrective action implementation
• Regulatory knowledge (FDA/EMA) related to sterility assurance

Education

• Bachelor‚Äôs degree in Microbiology, Biology, Chemistry, or related scientific field
• Preferred: Advanced degree in Microbiology, Biology, Chemistry, or related field

Additional Requirements

• On-site role based in King of Prussia, PA