• BS/MS degree in a scientific discipline; advanced degree (MS or PhD) preferred
• 15+ years of progressive Quality Control and/or Analytical Sciences experience in biotech/pharma industry (including outsourced operating models), with 7+ years in leadership roles
• Deep technical expertise in analytical methods supporting biologics and/or other advanced therapeutic modalities, including release, stability, and characterization testing.
• Strong working knowledge of USP, EP, and JP pharmacopeial requirements, and cGMP, ICH guidance, global regulatory requirements, and inspection readiness for outsourced QC operations.
• Demonstrated success leading global stability programs, including shelf-life support, data trending, protocol governance, and regulatory commitment execution.
• Proven experience in specification development, justification, and lifecycle management, including post-approval specification revisions and change implementation.
• Extensive experience with method transfer, qualification, validation, verification, and troubleshooting across contract testing laboratories and manufacturing partners.
• Proven ability to lead through influence in a matrixed organization and manage complex external technical relationships with appropriate rigor and accountability.
• Strong executive presence, sound scientific judgment, and the ability to balance strategic leadership with practical execution.
• Highly proactive, decisive, and capable of independently managing key initiatives.
• Engaged people manager committed to building culture as well as mentorship and talent development