Director, Quality Management Systems

Director of Quality Management Systems (QMS) is responsible for overseeing the GxP QMS to ensure compliance with regulatory requirements, industry standards, and company policies for the development, manufacturing, testing, release and distribution of pharmaceutical products (clinical and commercial).

• Develop, maintain and optimize global QMS strategy and processes based on regulatory requirements and corporate goals.
• Manage GxP QMS functions for clinical and commercial products:
  Document Control and Training;
  Non-conformance Management and CAPA;
  Internal QMS Audits;
  Quality Management Review;
  Change and Risk Management.
• Monitor emerging regulatory trends and adapt processes proactively.
• Lead and support risk assessments using current industry best practices.
• Partner with cross-functional teams (manufacturing, analytical development/quality control, supply chain, regulatory affairs, clinical and non-clinical development) to align on quality and compliance objectives.
• Identify, assess, and mitigate GxP-related risks across processes.
• Build, mentor, and lead a high-performing QMS team; foster quality, accountability, and collaboration.
• Strong leadership/team-building; analytical, problem-solving, and decision-making; organized, priority-setting, effective written/verbal communication.

• Bachelor's degree in life sciences, pharmacy, chemistry, or related field; advanced degree preferred.
• 10+ years in pharma/biotech (CDMO or CRO).
• 6+ years in QMS leadership, including clinical-to-commercial transition or pre-approval inspection readiness.
• Knowledge of GMP/GDP; ICH/FDA, EU MDR, ISO 13485; experience developing QMS/regulatory compliance programs.
• Strong communication/interpersonal skills; ability to influence stakeholders.
• Strategic thinker focused on continuous improvement; ability to work in fast-paced environment with evolving priorities.
• Occasional business travel.

• Advanced degree (PhD/MS) and experience supporting/preparing for PAI or commercial GMP inspections (FDA/EMA).
• Experience with electronic QMS platforms (e.g., Veeva Quality Docs, Track Wise).
• Experience in biologics or RNA-based therapeutic development.

Wisconsin pay range: $180,000 USD - $210,000 USD. Candidates must have current, valid authorization to work in the country where the role is located.