Job Summary

The Sterility Assurance Manager is responsible for leading and continuously enhancing the site's Sterility Assurance Program to ensure the highest standards of product quality, patient safety, and regulatory compliance. This role provides expert oversight of aseptic manufacturing operations, contamination control strategies, environmental monitoring programs, aseptic process simulations (media fills), cleanroom practices, and sterilization validation activities.

Working closely with Quality, Production, Technical Services, CQV, Project Management, Business Development, and Quality Control teams, the Sterility Assurance Manager serves as the site subject matter expert for aseptic processing and contamination control, ensuring compliance with GMP requirements, regulatory expectations, and Recipharm standards.

This is an individual contributor role with no direct reports.

Essential Job Functions

  • Lead and oversee the site's Sterility Assurance Program, ensuring ongoing compliance with GMP requirements, regulatory expectations, and internal quality standards.
  • Coordinate and oversee Aseptic Process Simulations (Media Fills) in collaboration with Production leadership, ensuring compliance with applicable regulatory guidance and company procedures.
  • Coordinate and oversee smoke studies with Production and CQV teams, including identification of critical interventions, airflow visualization requirements, and evaluation of study outcomes.
  • Review and approve Aseptic Process Simulation (APS) protocols and reports to maintain validation status and continuous compliance of aseptic filling operations.
  • Review, approve, and support implementation of Standard Operating Procedures (SOPs), risk assessments, contamination control documentation, and other quality system documents related to sterility assurance activities.
  • Manage and assess changes that impact sterility assurance, including modifications to aseptic processes, cleanroom operations, equipment, personnel and material flows, and facility design.
  • Perform risk assessments, laboratory studies, and evaluations to support contamination control strategies and continuous improvement initiatives.
  • Drive continuous improvement of sterility assurance processes and contamination control programs in partnership with cross-functional teams.
  • Partner with Business Development, Production, Technical Transfer, Project Management, Quality Control, and clients to address sterility assurance-related questions and regulatory inquiries.
  • Provide hands-on coaching and mentorship to manufacturing personnel on aseptic behaviors, cleanroom practices, contamination prevention, and GMP compliance.
  • Maintain independence from manufacturing operations to ensure objective quality and sterility assurance oversight.
  • Lead and support investigations related to sterility deviations, Out-of-Specification (OOS) results, and CAPA activities, ensuring timely completion and effectiveness.
  • Monitor and contribute to quality performance metrics and key performance indicators (KPIs).
  • Support innovation, operational excellence, and implementation of best practices that improve quality, compliance, and efficiency.
  • Protect confidential company and client information in accordance with Recipharm policies and applicable regulations.
  • Perform additional duties as assigned, consistent with the scope and responsibilities of the position.

Education

  • Master's Degree in Microbiology, Biotechnology, Biochemistry, Pharmacy, Chemistry, Chemical Engineering, or a related scientific discipline required.
  • Advanced training or certifications in Sterility Assurance, Aseptic Processing, Quality Systems, or Pharmaceutical Manufacturing preferred.

Experience & Skills

Experience

  • 8-10 years of experience within the pharmaceutical, biotechnology, or CDMO industry.
  • Significant experience in Quality Assurance, Sterility Assurance, Aseptic Manufacturing, or related GMP-regulated environments.
  • Proven experience supporting aseptic filling operations, media fills, contamination control programs, and cleanroom manufacturing environments.
  • Experience leading investigations, CAPAs, change controls, and risk assessments related to sterile manufacturing processes.
  • Experience working with regulatory inspections, customer audits, and health authority inquiries preferred.

Skills & Competencies

  • Subject matter expertise in aseptic processing and sterile manufacturing operations.
  • Strong knowledge of current Good Manufacturing Practices (cGMPs) and their practical application.
  • Expert understanding of FDA Guidance for Sterile Drug Products Produced by Aseptic Processing and EU GMP Annex 1 requirements.
  • Advanced knowledge of Contamination Control Strategy (CCS) principles and implementation.
  • Strong understanding of environmental monitoring, sterilization validation, smoke studies, media fills, and cleanroom qualification.
  • Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
  • Demonstrated ability to work independently, prioritize effectively, and manage multiple projects simultaneously.
  • Strong analytical, problem-solving, and decision-making capabilities.
  • Excellent communication, collaboration, and stakeholder management skills.
  • Ability to influence cross-functional teams and drive sustainable quality improvements.
  • Adaptable, resilient, and capable of working effectively within a dynamic operational environment.

Physical Demands

  • Ability to regularly work within manufacturing and cleanroom environments.
  • Ability to wear required personal protective equipment (PPE), including cleanroom gowning, for extended periods.
  • Ability to stand, walk, and move throughout production and laboratory areas for prolonged periods.
  • Ability to occasionally lift and carry materials weighing up to 25 pounds.
  • Visual acuity sufficient to review technical documentation, validation records, and manufacturing data.
  • Ability to perform routine inspections, observations, and audits within production, laboratory, and warehouse environments.
  • May require occasional travel for training, audits, client meetings, or business-related activities.

 

Annual Base Salary Range: $140,000 to $150,000

 

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