Executive Director, Quality Large Molecule Biological Critical Reagents

Job Description

Seeking an experienced leader to serve as Executive Director, Large Molecule Analytical Sciences (LMAS), Biological Critical Reagents (BCR). This position is accountable for building and running an efficient and high-performing organization that ensures reliable BCR supply to support on-time product release and new product introduction, while maintaining compliance with applicable regulations.

The candidate will interface extensively with R&D to ensure high technical rigor for introduction of new BCRs during commercialization of pipeline biologics and vaccines. The role also requires extensive engagement with Manufacturing, QA, Regulatory Affairs, and Supply Chain. The ideal candidate should have extensive experience in BCR implementation, qualification and supply chain management of critical reagents.

Responsibilities include but are not limited to:

• Lead end-to-end BCR operations across our Manufacturing Division: planning/forecasting, qualification and distribution for inline and pipeline products.
• Co-lead the enterprise Biological Critical Reagents Control Center (BCC) capital project, responsible for operational readiness, budget and schedule. CPTL for the program will report to this position.
• Ensure GMP/GLP and global regulatory compliance; prepare for and respond to inspections.
• Define and execute BCR strategy aligned to analytical and manufacturing goals, including capability planning, lab modernization, automation, and digital systems.
• Oversee QC systems, documentation, and data integrity (ALCOA+).
• Lead investigations (OOS/OOT/non-conformance), root-cause analysis, and corrective actions with QA and Manufacturing.
• Drive continuous improvement to reduce supply risk, cycle times, and costs.
• Manage BCR budget, capital, vendors, and external labs.
• Recruit, develop, and retain a high-performing team; create succession and development plans.
• Enable cross-functional support from tech transfer to commercial operations.
• Implement/maintain LIMS, ELN, and analytics for decision-making and regulatory submissions.
• Represent BCR in executive forums and external engagements.

Education/Experience Requirements: BS or BS/MS in Biology, Chemistry or related field with 15+ years of experience working in QC with focus in BCR supply chain and QC testing/qualification of BCRs.

Required Experience and Skills:

Leadership & Scope

• Lead up to 60 staff members (5-8 direct reports) including scientists, logistics managers, and planners managing E2E BCR supply for large-molecule GBO/GVO products. In addition, must extensively interface with R&D to build commercialization strategies in support of pipeline programs and execute new product introduction activities for BCRs to support RFT filing and launch.
• 10+ years managing people/processes in QC and/or Supply Chain with proven direct experience in method validation/transfer and BCR qualification across vaccines and biologics. Must have at least 5 years as a manager in a supply focused team (i.e. critical reagents, raw materials, or similar).
• Significant experience with GMP, ICH, FDA (CBER and CDER)/EMA requirements for biologic critical reagents.
• Drive supply planning, impact assessments, mitigation, and alignment with Global Quality (manufacturing and quality control laboratories).
• Own strategic development of supply planning (people, process, technology) and integrate within SCM Hoshin processes.
• Influence production plans, network siting and volumes, and filing strategies for sustained supply.
• Serve as the primary day-to-day executive sponsor for major capital facility projects critical to future BCR capacity (i.e. pipeline and inline growth)

Operational Accountabilities

• Serve as primary contact for GVO and GBO SCM Planning, Global Supply/Demand Reviews, site supply reviews, and inventory planning.
• Ensure the forecasting and adherence to BCR testing volumes within QC laboratories, inventory/safety stock levels, and material control strategy for inline and pipeline portfolios.
• Prioritize and resource planning initiatives (e.g., pipeline preparedness, capital project staffing) and lead scenario analyses to inform senior management.
• Communicate complex supply risks, impacts and mitigations to stakeholders up to executive level.
• Experience managing critical reagent procurement, qualification, stability, and global distribution, OOS/OOT investigations, and inspections.
• Proven people leadership, budget/capital management, and vendor oversight.
• Experience implementing labware systems (LIMS) and electronic notebooks (Signals) with adherence to Data Integrity QMS requirements.
• Strong communication, stakeholder influence, problem-solving, and risk-based decision-making skills.
• Recent and successful experience implementing our company's production systems frameworks on existing processes that resulted in efficiencies.

Preferred Leadership Competencies:

• Capable of dissecting and interpreting complex issues and creating effective action plans to deliver results.
• Demonstrates strong leadership in forming and guiding an agile team; able to influence effectively, establish credibility, and collaborate with a diverse set of stakeholders and partners.
• Collaborative team player experienced in matrix organizations; works cross-functionally, earns trust at all levels, and builds consensus around key priorities.
• Possesses solid business judgment and acumen; makes practical, data-driven decisions in a timely manner.
• Promotes and upholds rigorous, high-quality quality control standards with a commitment to scientific integrity, ethical practice, and diversity.

Required Skills:
Accountability, Accountability, Capability Based Planning, Capital Projects, Change Management, Confidentiality, Corrective Action Management, Cross-Cultural Awareness, Data Analytics, GMP Compliance, Inventory Planning, Key Client Relationships, Leadership, Motivation Management, New Product Development, Operational Quality, People Leadership, Pipeline Management, Portfolio Management, Quality Control Management, Quality Management Systems (QMS), Quality Risk Management, Quality Standards, Regulatory Compliance, Regulatory Inspections {+ 3 more}

Preferred Skills:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$206,200.00 - $324,600.00

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 [click to reveal website link]https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through [click to reveal website link]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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
11/18/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R372459