Senior Director, Quality Control

The Position

The purpose of this position within the Quality department is to lead Quality Control (QC) Laboratory consisting of analytical, microbial, stability, reference standard quality control, including raw materials, in-process, drug substance, and drug product testing across oligonucleotide and biologics platforms as needed. This includes the establishment and optimization of processes, procedures, analytical methods, and ensuring our Quality Control (QC) aligns with global quality and business objectives. The role functions as the GMP laboratory testing technical consultant to QC staff and business operations per strategic company needs. As the site transitions from clinical-stage to commercial operations, this role is the accountable QC owner for Pre-Approval Inspection (PAI) and commercial-readiness testing programs and leads a multi-manager QC organization with budget and headcount planning responsibility. This role requires close collaboration with Manufacturing, MSAT, Analytical Development, Regulatory, and Supply Chain to ensure QC strategy is integrated into broader site and program objectives.

Responsibilities

• Manage the full-scope of QC Laboratory operations including setting vision and strategy, operational planning, proposing and managing an annual budget, and plan and oversee laboratory space and resource needs.
• Manage a team of technical and analytical employees and managers, including setting goals to support organizational initiatives, workforce planning & hiring, career development, and coaching.
• Setting strategy, planning, coordinating, directing, coaching, developing, hiring, and planning the resources, facilities and budgets to manage the QC laboratory including setting of vision and strategy, develop and manage operating budgets, management of technical employees, project management, and unit operational management.
• Serve as the accountable QC owner for Pre-Approval Inspection (PAI) readiness, including method validation programs (e.g., internal and partner programs) through process performance qualification (PPQ) support, and for QC-related data integrity remediation actions.
• Oversee QC managers/supervisors across analytical, microbial, stability, and reference standard functions, as well as raw materials, in-process, drug substance, and drug product testing across oligo and biologics platforms; own the QC operating budget and headcount planning in alignment with the business plans.
• Ensure effective QC support of commercial manufacturing operations, process performance qualifications (PPQ) campaigns, technical transfers, and new product introduction, partnering with Manufacturing, MSAT, Analytical Development, and Regulatory to align QC readiness with program timelines.
• Ensure QC operations meet global GMP requirements and maintain a continuous state of inspection readiness, including ongoing self-inspection, CAPA closure, and audit-readiness programs that extend beyond the initial PAI.
• Apply scientific and technological expertise to the validation and optimization of analytical techniques for the identification and characterization of molecules oligo- and polynucleotides and raw materials in cGMP compliant laboratories. Apply extensive advanced scientific knowledge to design and manage multi-disciplinary projects.
• Provide leadership in product testing and Quality Systems to support overall business operations. Responsible for site processes and procedures related to QC laboratory to ensure product quality and compliance.
• Provide technical leadership in a multidisciplinary environment to ensure activities are on track per business needs and established timeline. Serves as an expert in technical/functional areas of Quality Control and Stability management.
• Establish and manage project timelines, testing turn-around times, and department schedules across multiple shifts.
• Develop, negotiate, finalize timelines and cost estimates for projects and/or service contracts to support business operations and/or external partner’s needs.
• Represent QC function during 3rd party, QP, and regulatory inspections at Verona, WI facility, including serving as a lead QC representative to FDA during Pre-Approval Inspection (PAI) and post-approval commercial inspections.
• Collaborate and execute on cross-functional goals with a diverse range of scientific professionals.
• Demonstrated leadership of projects and/or personnel for completion of assigned duties.
• Other duties consistent with the position as assigned from time to time.

Requirements

• 15 years of experience in a GxP pharmaceutical/biotech company, contract manufacturing organization, or contract research organization.
• 7 years of experience directing QC laboratory operations (including stability) in a cGMP facility, including direct oversight of multiple managers or supervisors and QC operating budget responsibility. Experience supporting FDA Pre-Approval Inspection (PAI) or commercial product launch preferred.
• Master's degree in a scientific field.
• Extensive knowledge of GMP and GDP regulations, as well as ICH/FDA guidance documents, including experience with development of applicable compliance programs.
• Knowledge of GLP/GCP regulations beneficial.
• Ability for occasional business travel.
• Strong people leadership skills.
• Solid understanding of financials and demonstrated budgetary management experience.
• Knowledge and understanding of operation of product quality control lab, product quality control requirement and system.

Preferred 

• PhD preferred