QC Microbiology Manager

Location: Allendale, NJ

Pay: $134K annually

Schedule: M-F, daylight hours

Qualifications:

• Bachelor’s degree in Microbiology or a related field.
• Biotechnology Certificate or cGMP experience is preferred.
• 7–10 years of experience in environmental monitoring or the biopharmaceutical industry.
• Expertise in QC microbial testing, method validation, and transfers.
• Strong knowledge of quality systems, compliance regulations (21CFR 210/211, 610, 1271, 11, EU Annex 1, cGMPs), and FDA guidance.
• Proficiency with Microsoft Office, MODA, and Visio.
• Strong organizational, leadership, and communication skills.
• Strategic and tactical thinking with the ability to adapt to growth.

Responsibilities:

Team Leadership

• Develop and implement effective hiring strategies.
• Recruit, train, and evaluate staff, ensuring competency and growth through feedback and performance reviews.
• Schedule, plan, and monitor workflows to align with business needs.
• Foster staff development and provide corrective counseling as necessary.

Operations Management

• Procure supplies and equipment to maximize departmental efficiency while meeting budgetary and quality goals.
• Lead equipment lifecycle management and optimize investments based on demand forecasts.
• Assure qualification and validation of laboratory equipment and microbial methods, including approval of protocols and reports.
• Manage microbial method in-sourcing to attract clients and generate revenue in collaboration with the Business Development team.

Technical Oversight

• Provide expertise for problem-solving, process improvements, and technical challenges.
• Lead project teams, utilizing operational excellence tools to drive project success.
• Investigate and document non-conforming events and environmental excursions, ensuring timely resolution and regulatory compliance.
• Monitor quality systems for efficiency, addressing audit findings and implementing effective change controls.

Continuous Improvement

• Simplify and standardize laboratory software for digital integration.
• Execute Continuous Improvement Projects to enhance best practices in the laboratory.
• Support cross-departmental initiatives and enforce a strong quality culture.

Regulatory and Client Engagement

• Ensure compliance with regulatory agency standards and client requirements for GMP cellular products.
• Interface with clients and regulatory agencies, participating in audits and issue resolution.
• Author and revise SOPs, Work Instructions, Forms, and Protocols to reflect up-to-date practices.