Associate Director - Quality Control, Microbiology

Role: Microbiology Associate Director

Location: El Paso, Texas

Alcott Global has been retained by a leading global organization in the pharmaceutical and medical device manufacturing sector. This leadership role is responsible for providing strategic direction and oversight for Quality Control, including Microbiology, Incoming Materials, and Chemical Laboratory operations, while ensuring compliance with FDA regulations (21 CFR Parts 210, 211, and 820), EU GMP, EU Annex 1, ISO 13485, and other global quality standards. As a key member of the site Quality Leadership Team, the Associate Director will drive quality strategy, regulatory readiness, and continuous improvement initiatives aligned with both global and site objectives.

The role will lead microbiological control, incoming material testing, chemical analysis, contamination control strategy (CCS), laboratory operations, data integrity, and regulatory readiness, ensuring robust quality systems, timely product disposition, and operational excellence. The individual will also work closely with Manufacturing, Supply Chain, Engineering, EHS, and other cross-functional teams to support compliant manufacturing operations, strengthen quality culture, and enable business objectives.

What we are looking for:

The ideal candidates will bring strong experience in pharmaceutical and/or medical device manufacturing, with a proven track record in Microbiology, contamination control, environmental monitoring, sterility assurance, water systems, incoming materials testing, chemical laboratory oversight, and data integrity.

Key Responsibilities: 

• Lead end-to-end laboratory operations across Microbiology, Incoming Materials Inspection & Testing, and Chemical/Analytical Laboratories, ensuring laboratories are adequately resourced, operationally efficient, and fully compliant with GMP (21 CFR Parts 210/211), ISO 13485, EU Annex 1, and global quality standards.
• Serve as the site Subject Matter Expert (SME) for Microbiology and Contamination Control, driving the site's Contamination Control Strategy (CCS), with oversight of Environmental Monitoring (EM), sterility, bioburden, water systems (PW/WFI), cleanroom qualification, cleaning validation, microbiological investigations, trending, and risk mitigation.
• Provide strategic oversight of Incoming Material Quality, ensuring robust sampling plans, testing strategies, supplier quality alignment, risk-based material release processes, and continuous improvements in testing efficiency while maintaining regulatory compliance.
• Lead Chemical and Analytical Laboratory excellence, overseeing analytical and microbiological method validation, verification and transfer, stability programs (where applicable), laboratory investigations (OOS, OOT, deviations), and ensuring the reliability, integrity, and regulatory compliance of analytical data supporting product quality and submissions.
• Drive Quality Systems, Regulatory Compliance, and Data Integrity, ensuring effective management of Deviations, CAPAs, Change Control, Risk Management (ICH Q9), ALCOA+ principles, LIMS and computerized laboratory systems, 21 CFR Part 11 compliance, CSV lifecycle activities, and acting as the laboratory lead during FDA, EU, and Notified Body audits, inspections, and regulatory responses.
• Build and develop a high-performing laboratory organization by providing leadership, coaching, and technical mentorship, fostering a culture of accountability, ownership, urgency, execution, continuous learning, and a strong quality mindset while ensuring appropriate microbiology and analytical expertise across the function.
• Drive continuous improvement and strategic initiatives to strengthen laboratory performance through improved cycle times, enhanced investigation effectiveness, robust microbiological control programs, implementation of automation and digital solutions, and alignment with site and global quality strategies through close collaboration with Manufacturing, Supply Chain, Engineering, EHS, and cross-functional stakeholders.

Candidate Profile:

• 10+ years of relevant experience in Quality Control, Microbiology, Laboratory Operations, Pharmaceutical Manufacturing, Biotech, or Medical Device Manufacturing
• 5+ years of leadership experience managing teams, programs, or site-level quality functions
• Strong knowledge of FDA, EU GMP, ISO 13485, cGMP, 21 CFR 210/211/820, Annex 1, and data integrity expectations
• Experience supporting regulatory inspections and interactions, including FDA inspections, 483s, and warning letter responses
• Strong ability to lead cross-functional teams, drive accountability, strengthen compliance culture, and support operational excellence
• Pharmaceutical manufacturing experience is strongly preferred or required for select roles
• Bilingual proficiency is preferred