Director, Quality Control

Merck•North Wales, PA

8d•Hybrid

About The Position

The Director, Biologic Critical Reagents is a senior scientific leader responsible for the strategy, sourcing, development, quality, and lifecycle management of critical biological reagents used across discovery, development, analytical testing, manufacturing, and quality. This role ensures reagent reliability, traceability, and regulatory compliance while driving innovation through robust platforms, process excellence, and strategic partnerships. The Director will lead a multidisciplinary, global team (including first-line managers and scientists) and collaborate extensively across inline and pipeline large molecule product initiatives.

Requirements

10+ years of experience in large molecule (biologics/vaccines) development, engineering, analytical sciences, or reagent development in relevant industries, including 4+ years in leadership roles.
Technical knowledge of biologic reagents and analytical methods (e.g., ELISA, SPR/BLI, SDS-PAGE, SEC, HPLC, qPCR, sequencing, cell-based assays).
Strong understanding of GMP/GxP requirements for large molecule commercial reagents as per global agency (e.g., FDA, EMA, and ICH) expectations for reference standards and analytical reagents.
Demonstrated experience in supplier qualification, contract negotiation, and external partnership management.
Experience with LIMS, inventory/reagent management, ELN, and electronic documentation and training/compliance systems.
Excellent leadership, communication, and stakeholder-management skills, with a track record of leading complex investigations and driving corrective and preventive actions.
Bachelor’s degree in Molecular Biology, Immunology, Biochemistry, Cell Biology, Virology, or related field.

Nice To Haves

Experience with monoclonal antibodies, recombinant proteins, cell and gene therapies, or vaccines.
Prior experience in a global, multi-site environment and with international regulatory interactions.
Training or certifications in project management, quality systems, or risk management (e.g., PMP, Six Sigma, CQE).
Advanced degree (MS or PhD) in Molecular Biology, Immunology, Biochemistry, Cell Biology, Virology, or related field preferred.

Responsibilities

Define and execute a global strategy for biologic critical reagents (e.g., reference standards, controls, cell banks, antibodies, viral stocks, enzymes, media, assay reagents) across the Large Molecule product lifecycle.
Establish governance, policies, and procedures for reagent selection, qualification, characterization, release, change control, storage, distribution, and disposal.
Drive reagent lifecycle management, including change control, comparability assessments, requalification, and retirement.
Implement risk assessment, criticality scoring, and business continuity planning to mitigate reagent supply risk.
Lead a team responsible for qualification of cell banks, reference materials, in-house standards, and assay controls.
Ensure reagent quality and fitness-for-purpose through adherence to acceptance criteria, stability programs, compliance standards, and ongoing monitoring (i.e., required qualification and re-certification testing).
Partner with subject matter experts in large molecule critical reagent management to ensure method development, remediation, validation, and lifecycle support for inline and pipeline reagents are taken up and supported in LM BCR.
Oversee the on-time supply of critical reagents to support end-to-end analytical technology transfer, including local batch release, registration, and testing on importation method siting decisions.
Partner with R&D, Analytical Development, Manufacturing, Quality, Regulatory, Clinical, and Supply Chain to meet functional and regulatory requirements for nonclinical, clinical, and commercial critical reagent activities.
Oversee vendor selection, qualification, contracting, and performance management for external suppliers and CMOs as per quality standards.
Implement and maintain documentation and data management systems (e.g., LIMS or equivalent) to ensure traceability and compliance with ALCOA+ principles.
Ensure strong GMP/GxP compliance and data integrity across reagent-related activities; serve as a quality and data integrity champion.
Author and implement global SOPs, drive SOP harmonization, and standardize training and second-scientist review practices across departments.
Lead investigations and root cause analyses for reagent-related failures or supply issues; implement robust corrective and preventive actions.
Build, mentor, and lead a high-performing, cross-functional team; develop talent and succession plans.
Lead global cross-functional teams and first-line managers; facilitate leadership team meetings, town halls, and cross-department forums.
Drive portfolio and resource prioritization, headcount planning and approvals, cost-saving insourcing initiatives, and serve as lab/facility liaison across multiple sites.
Champion MPS, Lean/5S, workflow and capacity optimization, Gemba activities, consumables management, and continuous improvement of LM BCR analytical operations.
Manage local BCR Sciences budget, capital investments, and vendor spend; present strategy, metrics, and status to site and global leadership.
Significant experience in Microsoft Office (including advanced Excel and VBA), DOE and statistical analysis (e.g., JMP).