QC Director, Lab Instrumentation, Digital Systems & Connectivity

Job description

Job Description At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and striving to find solutions and treatments for some of the world’s most challenging healthcare needs. The Wilmington Biotech Campus will play a pivotal role in the manufacture of our company’s biologics-based medicines, including the areas of immuno-oncology. This site will establish our company’s internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029. This facility will be a significant supplier of Antibody Drug Conjugates (ADCs) and High Potent Compounds and will also be critical in the future supply of new biotechnology products to its global network. Wilmington Biotech Campus – Quality Control Laboratory The Quality Control (QC) Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of our company’s pipeline of high potent Biologics. This laboratory will bring together late-stage analytical method development and validation with commercial release testing to deliver significantly improved speed through the analytical lifecycle. The laboratory will be supported by locally based advanced analytical subject matter experts and digital tools to enable an enterprise-wide connected laboratory in support of a new approach to analytical commercialization for high potent Biologics. The laboratory will be operated under our Manufacturing Division with close collaboration with our Research & Development Division. Reporting to the Executive Director, Wilmington Laboratory Operations, the Director of Laboratory Instrumentation, Digital Systems & Connectivity is the senior technical leader accountable for the end-to-end design, start-up, and sustained operation of all laboratory instrumentation, digital laboratory systems, and enterprise connectivity platforms for the Wilmington Quality Control Laboratories. This role will be a critical leader in the new facility and laboratory start-up program — supporting laboratory design, ensuring all necessary instrumentation and digital functionalities are incorporated, and leading start-up to meet all deliverables according to schedule. The role will define and execute the strategic vision for a fully connected, digitally enabled, paperless laboratory environment, ensuring that instrumentation, chromatography data systems (CDS), laboratory information management systems (LIMS), electronic laboratory notebooks (ELN), and enterprise data platforms are seamlessly integrated to enable the end-to-end analytical lifecycle. This includes driving the adoption of advanced digital tools, automation, and data analytics to support a new paradigm for analytical commercialization of high potent Biologics. Post laboratory start-up, the role will provide ongoing strategic leadership for instrumentation lifecycle management, digital system optimization, and continuous improvement of laboratory connectivity and data integrity across the site. Key Accountabilities: New Facility & Laboratory Start-Up: Support the design of the laboratory facility, partnering with Engineering, Quality, Digital, Manufacturing, and IT to ensure all necessary instrumentation, digital infrastructure, and connectivity functionalities are incorporated to support the end-to-end analytical lifecycle. Lead the design and specification of laboratory infrastructure requirements as they relate to instrumentation and digital systems; partner with Engineering and IT teams to ensure fit-out and utility provisions meet requirements. Develop and execute the integrated start-up master plan for instrumentation, digital systems, and laboratory connectivity, ensuring all deliverables are met according to schedule. Define and execute the commissioning, qualification, and validation (CQV) strategy for all laboratory instrumentation and digital systems, including IQ/OQ/PQ protocols and validation master plans; develop the phased equipment delivery, installation, and qualification schedule aligned with facility construction milestones. Support the execution of the laboratory operational readiness plan ensuring all systems are validated and inspection-ready prior to Health Authority submissions, including pre-approval inspection (PAI) readiness. Support the development of EHS policies and practices for the laboratory as they relate to instrumentation and high potent compound containment. Instrumentation Lifecycle Management Accountable for QC instrumentation strategy, selection, procurement, and delivery planning across all analytical platforms (HPLC/UPLC, mass spectrometry, spectroscopy, bioanalytical instruments, etc.) in partnership with global groups (Quality, IT, Digital, Analytical R&D, etc.) Lead instrument commissioning, qualification (IQ/OQ/PQ), and validation programs ensuring right-first-time execution and regulatory compliance. Develop and implement risk-based maintenance, calibration, and requalification strategies; manage vendor and qualification service provider relationships to ensure ongoing instrumentation is maintained in a fully validated and calibrated state, on schedule, on budget, and inspection-ready Quality & Compliance: Accountable for instrumentation related activities including review and approval of SOPs, protocols, and qualification documentation Serve as the subject matter expert during health authority inspections for instrumentation and laboratory systems. Lead investigations for system-related deviations, OOS/OOT events, and data integrity incidents; drive root cause analysis and CAPAs. Strategic & Technical Leadership Provide strategic direction and technical leadership for all laboratory instrumentation, digital systems, and connectivity platforms, ensuring alignment with site, network, and enterprise quality and digital objectives. Partner with cross-functional stakeholders (IT, Quality, Engineering, Manufacturing, Regulatory, Digital) to align laboratory digital strategy with global quality, compliance, and digital transformation priorities. Own the architecture and integration strategy for the connected laboratory ecosystem including LIMS, CDS (i.e. Empower), ELN, and enterprise data lakes Deploy advanced analytics, dashboards, and real-time monitoring tools for proactive instrument performance management and predictive maintenance. Champion automation, AI, and digital technologies to optimize laboratory throughput and data quality Qualifications / experience Education Bachelor's degree in Analytical Chemistry, Biology/Biochemistry, Engineering, Computer Science, or related discipline. Advanced degree preferred. Experience 12+ years of progressive industry experience in pharmaceutical/biotech laboratory operations with direct expertise in laboratory instrumentation, digital systems, and/or laboratory IT in a GxP environment. Demonstrated experience with new facility/laboratory start-up, such as facility design input, CQV strategy and execution, start-up master planning, and Health Authority approval readiness (PAI preparation). Expertise in LIMS, CDS (e.g., Empower), ELN, and instrument data management platforms. Proven experience designing and/or implementing connected/paperless laboratory environments. Strong understanding of data integrity requirements (ALCOA+, 21 CFR Part 11, EU Annex 11). Strong Quality background with direct experience defending content during health authority inspections preferred. Proven leadership including cross-functional stakeholder engagement 5+ years leading a team in a regulated Quality laboratory environment. Core competencies and skills Technical leadership in laboratory instrumentation and digital systems architecture Deep expertise in laboratory IT, data integrity, and enterprise connectivity in GxP environments Experience in data analysis, trending, and/or other types of