Job DescriptionGlobal Quality - Large Molecule Analytical Science (GQLMAS) - Quality Control Associate Director, Operational Readiness
Job Description
Reporting to the QC Laboratory Operations Lead, the Quality Control Associate Director - Operational Readiness is accountable for leading the end-to-end QC laboratory operational readiness strategy, integrated planning, and execution in support of the Wilmington Biotech Campus start-up and transition to routine operations. This role provides cross-functional leadership across laboratory operations workstreams, including laboratory start-up, sample management, materials readiness, stability operations, SOPs, training, and inspection readiness. The Associate Director will translate strategic start-up objectives into a single executable readiness plan aligned to the site Integrated Master Schedule, proactively identify risks, drive decisions, and ensure clear governance, escalation, and accountability across stakeholders. The role operates in parallel with construction, commissioning, and qualification activities to ensure the QC laboratory is prepared to accept handover and achieve successful facility approval readiness. Upon transition to steady-state operations, this role will own and continuously improve laboratory operations performance, establish standard work and governance routines, and drive operational excellence across the QC laboratory.
Key Accountabilities:Integrated Laboratory Operational Readiness Planning & Schedule- Lead the development, maintenance, and governance of the QC laboratory operations readiness schedule across workstreams, ensuring alignment to the site Integrated Master Schedule, critical path, and enterprise readiness milestones.
- Own cross-functional schedule integration, dependency mapping, and readiness governance to ensure procedures, training, materials, and method-related deliverables are sequenced and executed effectively.
- Drive schedule convergence and acceleration by identifying dependencies, sequencing conflicts, resourcing gaps, and pull-forward actions; lead escalation of overdue or at-risk deliverables and ensure timely decision-making.
- Establish laboratory operations readiness stage-gates, define entry and exit criteria, and lead stakeholder reviews to confirm readiness at critical project milestones.
- Partner with cross-functional stakeholders across Quality, Manufacturing, Supply Chain, Facilities/Engineering, Research & Development Division, IT, and site operational readiness teams to align laboratory operations readiness with site start-up and facility approval timelines.
- Provide leadership visibility to readiness risks, issues, and decisions through structured governance, dashboards, metrics, and clear communication to site and functional leadership.
Additional Laboratory Operational Readiness Activities include;SOPs & Document Readiness- Define and lead the document readiness strategy for laboratory operations, including SOPs, Work Instructions, Job Aids, training materials, and operational governance documents required for start-up and routine execution.
- Ensure document ownership, review, approval, and training timelines are integrated into the master readiness schedule and aligned with facility, equipment, system, and process readiness milestones.
- Establish document readiness metrics and governance routines to monitor progress, remove barriers, and ensure inspection-ready documentation is available when required.
Sample Management- Lead the design and implementation of the end-to-end sample management operating model, including receipt, login, storage, tracking, distribution, retention, disposal, chain of custody, and data integrity controls.
- Partner with Digital, Quality, Research & Development Division, Supply Chain, and laboratory stakeholders to ensure sample workflows, system master data, LIMS functionality, and operational procedures support start-up and routine QC testing requirements.
- Establish governance and performance measures for sample management to ensure traceability, right-first-time execution, and reliable support of release, stability, qualification, and validation testing.
Laboratory Inventory Management- Lead the development of the laboratory inventory management strategy for consumables, chemicals, reagents, reference standards, standards, solutions, and supplies required to support QC start-up and sustained operations.
- Ensure material master data, reorder points, storage requirements, and inventory controls are aligned to start-up sequencing and routine operational demand.
Stability Program Operations- Provide operational leadership for stability program readiness, including input to facility design, start-up of stability storage and support areas, sample pull scheduling, storage condition management, sample distribution, and supporting procedures.
- Partner with Quality, Research & Development Division, Manufacturing, Supply Chain, and laboratory stakeholders to ensure stability operations are integrated with site readiness plans, digital systems, and regulatory expectations.
- Establish operational controls and performance measures to ensure the stability program is inspection-ready and capable of supporting launch and routine commercial operations.
Quality & Compliance- Ensure all laboratory operations readiness and routine execution activities comply with cGMP, corporate quality policies, data integrity expectations, and applicable regulatory requirements, including FDA, EMA, and ICH expectations.
- Provide leadership oversight for laboratory operations-related deviations, OOS/OOT assessments, root cause analyses, CAPAs, and change controls; ensure appropriate escalation, impact assessment, and timely closure.
- Partner with Quality, Regulatory, Manufacturing, Engineering, Digital, and Research & Development Division stakeholders to ensure operational readiness decisions are compliant, risk-based, and aligned to site priorities.
POST GO-LIVE: Steady-State Operations- Lead the long-term laboratory operations model across sample management, solution/reagent preparation, inventory management, planning/scheduling, stability operations, and supporting QC workflows to ensure uninterrupted support of testing and reliable supply.
- Lead continuous improvement through standard work, lean practices, digital enablement, automation opportunities, and benchmarking against network best practices.
- Provide leadership oversight for laboratory operations-related investigations, CAPAs, change controls, and operational risks to ensure sustained compliance and performance.
- Build and sustain effective governance routines, escalation pathways, and cross-functional engagement to support laboratory operations performance, inspection readiness, and future growth.
Qualifications / experienceEducation- Bachelor's degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline is required; advanced degree preferred.
Experience- Minimum of 10 years of relevant experience in Quality Control, analytical laboratory operations, pharmaceutical/biotech manufacturing support, or a related regulated scientific discipline, with demonstrated progression in responsibility.
- Demonstrated leadership experience in laboratory operations, operational readiness, large-scale start-up, capital project support, or complex cross-functional program execution is required.
- Proven experience leading cross-functional teams, governance forums, or workstreams across Quality, Manufacturing, Supply Chain, Engineering, IT/Digital, and analytical development stakeholders.
- Strong experience with laboratory start-up activities, including equipment and system readiness, SOP and training readiness, sample management, inventory/material readiness, stability operations, and inspection readiness.
- Strong quality background with direct experience supporting internal audits, regulatory inspections, readiness assessments, or health authority inspection preparation.
- Experience in cGMP environments, QC laboratory operations, data integrity expectations, and quality management systems is required.
- Strong working knowledge of laboratory and quality systems such as LIMS, inventory systems, Veeva, Kneat, MODA, Empower, SAP, or other digital laboratory tools is preferred.
- Experience providing leadership oversight for deviation/OOS investigations, change controls, CAPAs, quality risk assessments, and continuous improvement initiatives.
- Demonstrated Lean, Six Sigma, operational excellence, or continuous improvement experience preferred.
- Formal project management experience or PMP certification preferred.
Core competencies and skills- Strategic and operational leadership with the ability to translate start-up objectives into executable plans, governance routines, and measurable outcomes.
- Strong cross-functional leadership and stakeholder management skills, with the ability to influence decisions and drive alignment across functions without direct authority.
- Excellent organizational and prioritization skills; able to manage complex interdependencies, competing priorities, and accelerated timelines in a dynamic start-up environment.
- Strong quality and compliance mindset, with the ability to proactively identify risks, compliance gaps, and operational vulnerabilities and drive effective resolution.
- Demonstrated problem-solving, risk assessment, decision-making, and escalation framing skills.
- Strong communication and executive presentation skills, including the ability to clearly communicate readiness status, risks, decisions, and priorities to site and functional leadership.
- Commitment to data integrity, right-first-time execution, inspection readiness, and continuous improvement.
- Ability to build standard work, develop scalable processes, and drive sustainable laboratory operations performance through people, process, and digital enablement.
Additional Info:- Location: Wilmington Delaware (On-Site)
- Travel: Ability to travel ~5% of the time
Required Skills: Analytical Method Development, Analytical Method Development, Analytical Problem Solving, Analytical Thinking, Audit Readiness, Audit Trails, Biological Analysis, Change Controls, Commercial Operations Management, Continuous Improvement Tools, Controls Management, Counterfeit Detection, Cross-Functional Project Management, Cross-Functional Teamwork, Data Integrity, Driver Management, Good Manufacturing Practices (GMP), Identifying Customer Needs, Innovation, Microbiological Analysis, Operational Quality, People Management, Process Alignment, Progress Monitoring, Quality Assurance Processes {+ 10 more}
Preferred Skills: Current Employees apply HERE
Current Contingent Workers apply HERE
The salary range for this role is
$129,000.00 - $203,100.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the
