Building expert teams to advance science.

About the Role

At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent! We are seeking an Associate Director of Quality to join our expanding team.

The Associate Director, Quality Control Microbiology is a key quality leader responsible for developing, executing, and continuously improving the microbiology, environmental monitoring, contamination control, and raw material testing programs supporting viral vector manufacturing for cell and gene therapy clients.

As a member of the Site Quality leadership team, this role provides strategic and operational leadership for QC Microbiology while ensuring regulatory compliance, inspection readiness, client confidence, and scalable growth. The Associate Director will partner closely with Quality Assurance, Manufacturing, MS&T, Facilities, Supply Chain, and Client Program teams to maintain a robust contamination control strategy aligned with global regulatory expectations and industry best practices.

This position requires a balance of scientific expertise, operational excellence, and people leadership to build a best-in-class QC Microbiology organization capable of supporting clinical and commercial manufacturing operations.

Our core values of Reliable, Outcome Driven, Scalable, and Excellent guide how we operate, support our clients, and ultimately improve patient outcomes.  

Key Responsibilities

Strategic Microbiology Leadership

• Lead the strategic direction of QC Microbiology operations in support of viral vector manufacturing programs across clinical and commercial stages.

• Develop and implement sustainable microbiology capabilities, laboratory infrastructure, and organizational strategies to support site growth and commercialization.

• Serve as the site Subject Matter Expert (SME) for microbiological quality systems, contamination control, and aseptic processing support.

• Drive continuous improvement initiatives focused on quality, compliance, efficiency, and scalability.

• Establish metrics and performance indicators to monitor laboratory effectiveness, compliance, and operational excellence.

Contamination Control & Environmental Monitoring

• Own and continuously improve the site Environmental Monitoring (EM) Program, including routine monitoring, trending, excursion management, and performance assessment.

• Partner with Manufacturing, Engineering, and Facilities teams to maintain effective contamination control strategies across classified environments.

• Provide microbiological oversight for cleanroom qualification, utilities monitoring, disinfectant programs, and aseptic manufacturing support.

• Lead development and maintenance of the site Contamination Control Strategy in alignment with FDA, EMA, Annex 1, and industry expectations.

• Evaluate emerging technologies and rapid microbial methods to strengthen contamination detection and process monitoring capabilities.

Quality Systems & Regulatory Compliance

• Ensure QC Microbiology activities comply with global regulatory expectations, including FDA, EMA, MHRA, ICH, USP, EP, and applicable cGMP requirements.

• Provide leadership and oversight for microbiology-related deviations, laboratory investigations, environmental monitoring investigations, OOS/OOT events, CAPAs, change controls, and risk assessments.

• Review and approve microbiology documents including SOPs, protocols, reports, validation documents, specifications, and technical assessments.

• Lead inspection readiness activities within QC Microbiology and ensure sustainable compliance across laboratory operations.

• Serve as a primary QC Microbiology representative during regulatory inspections, client audits, and due diligence assessments.

Client and CDMO Partnership

• Act as the QC Microbiology SME for client programs, supporting technical discussions, audits, investigations, comparability activities, and technology transfers.

• Partner with Business Development and Program Management teams to support client engagement, proposals, and operational planning.

• Collaborate cross-functionally to ensure successful execution of client timelines and quality commitments.

• Foster strong client relationships through scientific expertise, transparency, and effective communication.

Operational Excellence

• Ensure timely execution of microbiology testing activities including environmental monitoring, bioburden, endotoxin, growth promotion, sterility support, water monitoring, and raw material microbiological testing.

• Lead laboratory capacity planning and resource optimization to support increasing manufacturing demand.

• Implement data-driven decision making through laboratory metrics, trend analysis, and performance management.

• Champion data integrity principles and effective utilization of laboratory systems and electronic quality platforms.

Leadership and Culture

• Build, develop, and mentor a high-performing QC Microbiology organization that thrives in a fast-paced, science-driven CDMO environment.

• Establish a culture of accountability, collaboration, technical rigor, and continuous improvement.

• Develop succession plans and talent pipelines to ensure organizational scalability and long-term success.

• Promote employee engagement, professional growth, and leadership development.

• Champion Rose BioSolutions values:

  • Reliable: Deliver quality and compliance with consistency and integrity.

  • Outcome Driven: Focus on actions that support client success and patient impact.

  • Scalable: Build systems and teams capable of supporting sustained growth.

  • Excellent: Pursue the highest standards of scientific, operational, and leadership performance.

Qualifications and Experience

Education

• Bachelor's degree in Microbiology, Biology, Life Sciences, Biotechnology, or related discipline required.

• Advanced degree (MS, PhD, or MBA) preferred.

Experience

• Minimum 10 years of progressive Quality Control Microbiology experience within cGMP-regulated biologics, vaccines, cell therapy, gene therapy, or advanced therapy manufacturing environments.

• Minimum 5 years of leadership experience managing microbiology laboratories and technical teams.

• Experience supporting viral vector manufacturing programs preferred, including AAV, lentiviral, adenoviral, or related advanced biologic platforms.

• Demonstrated experience within a CDMO environment strongly preferred.

• Proven track record supporting regulatory inspections, client audits, and quality system management.

• Experience supporting clinical-to-commercial scale-up activities and organizational growth preferred.

Technical Expertise

• Deep knowledge of microbiological quality systems, contamination control, environmental monitoring, and aseptic manufacturing.

• Strong understanding of FDA, EMA, MHRA, ICH, USP, EP, and Annex 1 requirements.

• Expertise in microbiology investigations, CAPA development, risk assessment, and root cause analysis.

• Experience with electronic Quality Management Systems (eQMS), LIMS, environmental monitoring databases, and data integrity requirements.

• Knowledge of Lean, Operational Excellence, or Six Sigma methodologies preferred.

COMPENSATION DATA:

The pay range for this position is $156,000-176,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Why Join Us?

Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.

Expertise: Work alongside a world-class team of scientists and operational leaders in a "no-ego" environment.

Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.

Perks & Benefits

• Competitive base salary with performance-based bonus opportunities.

• Comprehensive health, dental, and vision insurance.

• 401(k) with company contribution.

• Generous PTO and professional development support.

Rose BioSolutions is an equal opportunity employer committed to a diverse and inclusive workforce.