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 mana