Sr. Director, QC Microbiology

Position Overview:

The Senior Director, Quality Control (QC), Microbiology will lead the strategy, execution, and oversight of key QC functions, including sample management, environmental monitoring, contamination and aseptic control, microbiology testing, raw materials qualification and testing, analytical instrument qualification, and pre-license inspection (PLI) readiness activities. This role is pivotal to shaping the overall facility strategy and driving the growth of the Quality organization at the North Carolina (NC) site.

The NC manufacturing facility specializes in advanced therapeutic technologies, including cell and gene therapy modalities. It currently operates as a clinical-phase manufacturing plant with plans to transition multiple programs to commercial production within the same facility.

This position places a strong emphasis on contamination control, aseptic processing, and environmental monitoring/microbiology to ensure robust systems and processes that maintain compliance with Good Manufacturing Practices (GMP). The Senior Director will report directly to the Vice President, Quality Control.

Primary Responsibilities:

• Strategic Leadership: Develop and implement the overall QC strategic plan to support site and organizational objectives.
• Management:Lead a diverse team of subject matter experts in microbiology, raw materials, and analytical instrument qualification.
• Contamination Control: Own and manage the facility’s contamination and aseptic control programs.
• Environmental Monitoring: Design and oversee the execution of the site’s environmental monitoring program.
• Microbiology & Sterility Testing: Define and implement sterility and biological testing/validation requirements for cell and gene therapy products in alignment with industry standards.
• Raw materials:Design and oversee the execution of the raw materials testing strategy including materials categorization, risk assessments, method qualification, and testing.
• Testing Oversight: Ensure timely, accurate raw material, in-process, and final product release testing.
• Sample Management: Oversee sample control processes, including retain management.
• Compliance: Ensure adherence to cGMP principles within internal and external laboratories.
• Documentation & Review: Manage internal and external cGMP labs by reviewing and approving SOPs, protocols, reports, test methods, change requests, technical transfers, and OOS investigations.
• Resource Allocation: Ensure projects have appropriate QC resources to meet timelines and deliverables.
• Continuous Improvement: Drive continuous improvement initiatives in QC processes, systems, and technologies to enhance efficiency and compliance.
• Compliance: Maintain QC systems and equipment in compliance with guidelines and data integrity principles including collaborating cross-functionally on analytical instrument qualification and associated software tool validation strategy
• PLI Readiness:Build appropriate processes, systems, and training in preparation to support PLI inspections as well as continued external audits by regulators
• Data Management: Track and trend cGMP data and compile reports for management reviews, Annual Product Reviews, and other required assessments.
• Team Development: Foster a culture of continuous improvement within the QC organization.

Embodies Beam’s cultural values and aligns daily actions with departmental goals and company culture.

Qualifications:

• Education: Bachelor’s or advanced degree in a scientific discipline.
• Industry Experience: Minimum of 12 years in the pharmaceutical or biotech industry, encompassing drug substance/drug product manufacturing, development, and/or quality. Strong preference for direct experience in cell and/or gene therapy manufacturing environments.
• Leadership: Proven experience leading teams within Quality and Quality Control functions, with emphasis on contamination control, microbiology, and raw material testing.
• Management: At least 5 years of experience in Quality management roles.
• Regulatory Expertise: Demonstrated experience interacting with regulatory health authorities during pre- and post-approval inspections.
• Technical Knowledge: Solid understanding of global regulations, cGMP principles, and industry standards.
• Communication Skills: Excellent verbal and written communication abilities, with strong attention to detail and capability to influence and drive change across functions.
• Collaboration: Strong team player with a customer-focused, solution-oriented mindset; able to work independently, within cross-functional teams, and with external partners and vendors.
• Leadership Competencies: Exceptional team-building, leadership, and interpersonal skills that foster collaboration and team spirit.
• Performance: Consistent track record of delivering high-quality work and meeting corporate objectives.
• Vendor Management: Skilled in managing vendors and external partners involved in Quality and Regulatory activities.
• Technical Requirements: Ability to gown and enter GMP cleanroom environments.

Directions to apply: Submit your resume to careers@beamtx.com

Please list this job title in the Subject of your email. Qualified candidates will be contacted immediately!

Relocation assistance is available for qualified candidates.