The Position

The purpose of this position within the Quality and Compliance department is to lead Quality Control (QC) Laboratory consisting of analytical, microbial, stability, reference standard quality control. This includes the establishment and optimization of processes, procedures, analytical methods, and ensuring our Quality Control (QC) align with business strategy and needs. Functions as the GMP laboratory testing technical consultant to QC staff, business operations per strategic business needs.

Responsibilities

• Setting strategy, planning, coordinating, directing, coaching, developing, hiring, and planning the resources, facilities and budgets to manage QC laboratory including setting of vision and strategy, develop and manage operating budgets, management of technical employees, project management, and unit operational management.
• 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 System to support overall business operations. Responsible for site processes and procedures related to Quality Control 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.
• Apply advanced technical writing skills to prepare project protocols and reports to support product registration and/or business needs. Technical Reports and Procedural Documents (SOPs, Wis, Test Methods, Policies, Forms, ).
• 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 3^rd party, QP, and regulatory inspections at Verona, WI facility.
• Hiring and development of QC department staff at the Verona, WI
• Other duties consistent with the position as assigned from time to time.

Requirements:

• Master's Degree 
• 10 years of experience in a GxP pharmaceutical/biotech company, contract manufacturing organization, or contract research
• 5 years of experience Directing QC laboratory in cGMP facility.
• 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
• Understanding of document control requirements in a FDA regulated
• Competent knowledge of and ability to use Microsoft Word and Excel
• Ability for occasional business
• Strong people leadership skills.
• Solid understanding of financials and budgetary management experience.
• Knowledge and understanding of operation of product quality control lab, product quality control requirement and system.
• Shows broad understanding of the issues relevant to the technical/science and business

Preferred: 

• Doctorate degree