Director/Sr. Director, Quality Control

Liquidia•,

1d•Onsite

About The Position

The Director / Senior Director, Quality Control will serve as a key member of the Quality Leadership Team and will be responsible for building, leading, and managing the Quality Control function at Liquidia’s new manufacturing facility. This role will oversee the operationalization of the QC laboratory, including laboratory readiness, equipment commissioning and qualification, staffing, and method transfer and validation activities required to support product release and stability testing. Once the facility is operational, this leader will be accountable for day-to-day QC laboratory operations, ensuring timely, accurate, and compliant testing in support of commercial manufacturing, batch disposition, stability programs, and regulatory commitments. The ideal candidate will bring strong technical expertise in analytical laboratory operations, including chromatographic, spectroscopic, and analytical characterization techniques, along with a practical understanding of GMP requirements, data integrity expectations, and regulatory standards applicable to QC laboratories. This individual will be expected to build a high-performing team, establish scalable laboratory processes, and foster a culture of technical excellence, compliance, accountability, and continuous improvement.

Requirements

Advanced degree, such as an M.S. or Ph.D., in Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline.
Minimum of 15 years of pharmaceutical or biotechnology experience in Quality Control, Analytical Development, or a related laboratory function supporting GMP operations.
Minimum of 8 years of experience leading and managing teams, including hiring, developing, mentoring, and performance management of scientific staff.
Experience building or operationalizing a new QC laboratory or manufacturing facility, including laboratory equipment commissioning and qualification.
Direct experience supporting FDA inspections, including participation in or hosting of inspections in a QC laboratory environment.
Demonstrated experience with analytical method transfer, method validation, and implementation of validated methods in a GMP laboratory setting.
Strong technical knowledge of chromatographic techniques, including HPLC, UHPLC, and GC, as well as spectroscopic techniques such as FTIR and UV-Vis.
Experience with additional analytical methods, including Karl Fischer titration, compendial physical testing, and related laboratory techniques.
Thorough understanding of USP/EP compendial methods and their application to product release, stability testing, and ongoing laboratory operations.
In-depth knowledge of cGMP regulations, FDA expectations, and relevant ICH guidelines as they apply to QC laboratory operations.
Strong understanding of data integrity requirements, including 21 CFR Part 11 and EU Annex 11 expectations, and their practical application to laboratory instruments, systems, electronic records, and computerized workflows.
Demonstrated knowledge of OOS/OOT investigations, laboratory failure investigations, root cause analysis, and CAPA development.
Ability to author, review, and approve laboratory procedures, protocols, reports, methods, specifications, and technical documents with strong attention to detail.
Strong leadership, communication, and collaboration skills, with the ability to work effectively across Quality, Manufacturing, Engineering, Regulatory, Supply Chain, and existing QC functions.
Proven ability to build, lead, and scale a high-performing QC team in a fast-paced, growth-oriented GMP environment.

Nice To Haves

Experience working within a multi-site QC or Quality organization, including alignment of site-level procedures, methods, investigations, and metrics.
Experience with inhaled products and related test methods.
Experience supervising a microbiological testing lab.
Working knowledge of environmental monitoring programs, including viable and non-viable particulate monitoring, cleanroom classification, and utility monitoring.
Experience developing or implementing QC laboratory metrics, KPIs, and processes to support Quality Management Review and operational performance monitoring.

Responsibilities

Lead the buildout and operationalization of the QC laboratory at Liquidia’s new manufacturing facility, including laboratory readiness, equipment selection, installation, commissioning, and qualification.
Establish the new site QC organization, including hiring, onboarding, training, and developing a team of QC professionals.
Build scalable QC laboratory processes, systems, and ways of working to support both start-up activities and steady-state commercial operations.
Ensure new site QC processes are aligned with applicable Liquidia Quality standards, procedures, and expectations across the broader QC organization.
Oversee the transfer, qualification, and validation of analytical methods to support product release, stability testing, and regulatory requirements.
Manage day-to-day QC laboratory operations at the new manufacturing facility, ensuring testing is completed accurately, compliantly, and on schedule to support manufacturing and batch disposition.
Provide technical leadership for chromatographic, spectroscopic, particle characterization, and other analytical testing activities.
Lead and/or support QC laboratory investigations, including OOS/OOT and laboratory events, ensuring investigations are scientifically sound, timely, well-documented, and compliant with regulatory expectations and internal procedures.
Ensure QC laboratory operations, systems, procedures, and records comply with cGMP requirements, data integrity expectations, 21 CFR Part 11, EU Annex 11, and Liquidia internal procedures.
Establish and maintain site QC laboratory SOPs, analytical methods, specifications, protocols, reports, and training materials, as applicable.
Collaborate cross-functionally with Quality Assurance, Manufacturing, Process Engineering, Regulatory Affairs, Supply Chain, existing QC operations, and other stakeholders to support business needs and maintain alignment on quality and compliance expectations.
Develop, monitor, and report QC metrics and KPIs to support Quality Management Review and ongoing operational performance management.
Proactively identify laboratory risks, compliance gaps, and opportunities for improvement, and lead continuous improvement initiatives within new site QC operations.
Support regulatory inspection readiness activities and serve as the QC representative for the new manufacturing facility during FDA and other regulatory authority inspections.
Apply a risk-based approach to decision-making, issue escalation, investigation support, and operational problem solving.
Perform other duties as assigned