Supervisor, Quality Control

Key Responsibilities:

Laboratory Operations & Testing

• Oversee daily operations and testing activities within the QC Microbiology Laboratory.
• Ensure timely and compliant execution of microbiological testing to support manufacturing and product release.
• Perform routine review and approval of test data, laboratory records, and associated documentation.
• Support the generation and review of Certificates of Analysis (CoAs) for product release.

Environmental Monitoring & Compliance

• Lead and sustain the site's Environmental Monitoring (EM) and Utilities Monitoring (UM) programs.
• Monitor environmental and utility data, identify trends, and communicate findings to management.
• Assemble reports and provide routine updates on environmental monitoring performance and compliance.
• Implement corrective and preventive actions when adverse trends or excursions are identified.
• Support optimization of the aseptic gowning qualification and training program.

Leadership & Team Development

• Supervise QC Microbiology staff and laboratory activities.
• Conduct performance evaluations, coaching, and regular employee development discussions.
• Maintain training programs and ensure ongoing qualification of QC Microbiology personnel.
• Foster a culture of quality, compliance, accountability, and continuous improvement.

Investigations & Problem Solving

• Serve as Subject Matter Expert (SME) for EM and UM investigations.
• Lead or support investigations involving:
  • Environmental monitoring excursions
  • Utilities monitoring excursions
  • Out-of-Specification (OOS) results
  • Deviations associated with microbiological procedures
• Identify root causes and implement effective corrective and preventive actions (CAPAs).

Quality Systems & Documentation

• Develop, review, revise, and approve:
  • Standard Operating Procedures (SOPs)
  • Validation and qualification protocols
  • Validation and qualification reports
  • Controlled quality documentation
• Monitor GMP systems to ensure continued compliance with internal procedures and regulatory requirements.
• Review proposed changes to methods, procedures, systems, and regulatory submissions as needed.

Audits & Regulatory Support

• Support internal, customer, and regulatory inspections and audits.
• Ensure laboratory activities remain compliant with cGMP requirements and company quality standards.
• Represent the QC Microbiology function during cross-functional, site, and global meetings.

Continuous Improvement & Communication

• Collect and analyze departmental metrics to drive continuous improvement initiatives.
• Provide updates and key performance indicators during daily, weekly, and management meetings.
• Collaborate with Manufacturing, Quality Assurance, Validation, Facilities, and other functional groups to support site objectives.
• Perform additional responsibilities and special projects as assigned.

Preferred Qualifications:

• Bachelor's degree in Microbiology, Biology, Biochemistry, Life Sciences, or related scientific discipline with at least 5 years of experience in QC Microbiology within a pharmaceutical, biotechnology, cell therapy, or other GMP-regulated environment.
• Previous supervisory or leadership experience managing laboratory personnel.
• Strong experience with:
  • Environmental Monitoring (EM)
  • Utilities Monitoring (UM)
  • Aseptic processing and gowning qualification
  • OOS, deviation, and CAPA investigations
  • Product release support
• Working knowledge of FDA, EMA, and cGMP regulations.

Knowledge, Skills & Abilities:

• Strong understanding of microbiology laboratory operations within a cGMP environment.
• Expertise in environmental monitoring programs, data trending, and contamination control principles.
• Proven ability to lead investigations and perform root cause analysis.
• Excellent leadership, coaching, and employee development skills.
• Strong technical writing and documentation review capabilities.
• Effective verbal and written communication skills with the ability to interact across all levels of the organization.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Demonstrated commitment to quality, compliance, and continuous improvement.