Executive Director, Quality Large Molecule Biological Critical Reagents

Executive Director, Quality Large Molecule Biological Critical Reagents Join to apply for the Executive Director, Quality Large Molecule Biological Critical Reagents role at Merck 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. Responsibilities 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 and 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 end‑to‑end BCR supply for large‑molecule GBO/GVO products. 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; at least 5 years as a manager in a supply‑focused team. 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 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 the 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. Compensation and Benefits Salary range: $206,200.00 – $324,600.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, and other insurance benefits for employee and family, retirement benefits (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. Work Arrangement Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid model 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 model does not apply to field‑based positions, facility‑based, manufacturing‑based, or research‑based positions where work is performed at a company site; positions covered by a collective‑bargaining agreement; or any other position for which the company has determined that the requirements cannot be reasonably met remotely. Equal Employment Opportunity As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement. #J-18808-Ljbffr