Executive Director, Quality Large Molecule Biological Critical Reagents

Executive Director, Large Molecule Analytical Sciences

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

Operational Accountabilities

Preferred Leadership Competencies

Required Skills : 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

Preferred Skills

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 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.

Search Firm Representatives Please Read Carefully 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.