Quality Control Lab Operational Readiness

Job Description

Global Quality – Large Molecule Analytical Science (GQLMAS) – Quality Control Associate Director, Operational Readiness

 

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 it’s global network.

 

Wilmington Biotech Campus – Quality Control Laboratory

 

The 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 company's Manufacturing Division with close collaboration with Research & Development Division.

 

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 / experience

 

Education

• 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.

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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:

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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 time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/30/2026

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