Global QC Product Lead

Preferred Qualificationsnice to have

• Broad experience across both analytical development and commercial QC environments.
• Experience with multiple analytical technologies, modalities, product types, and/or global QC laboratories.
• Experience supporting regulatory submissions, health-authority responses, regulatory inspections, or analytical-method-related commitments.
• Demonstrated experience with complex analytical method validation, transfer, investigations, remediation, and lifecycle management.
• Experience establishing platform approaches, global standards, technical governance models, or laboratory capability strategies.
• Demonstrated scientific leadership through mentoring, capability building, knowledge sharing, and continuous improvement.

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our long-term incentive programs.

• Lead the global QC analytical implementation and lifecycle strategy for assigned late-stage and commercial products.
• Represent Global QC as a key Quality and scientific decision-maker in cross-functional product, CMC, analytical, validation, and transfer discussions.
• Translate development analytical strategies into robust, compliant, and sustainable approaches for routine QC execution.
• Provide strategic QC input from late-stage development through validation, co-validation, transfer, commercialization, troubleshooting, and ongoing lifecycle management.
• Independently review, challenge, and approve proposed validation, co-validation, and analytical method transfer strategies from a QC implementation perspective.
• Determine the final QC method design by balancing scientific requirements, product and regulatory needs, laboratory controls, network capability, and long-term sustainability.
• Assess receiving-site readiness, including technical expertise, instrumentation, laboratory controls, capacity, documentation, and operational constraints.
• Partner with QC sites and technical teams to identify and mitigate barriers to successful method implementation and reliable routine execution.
• Lead alignment across R&D, PDS&T, QC Operations, Operations Quality Assurance, Regulatory Affairs, CMC, and product teams.
• Provide scientific and Quality leadership for complex method transfer challenges, validation investigations, analytical issues, and cross-site troubleshooting.
• Identify and communicate scientific, Quality, regulatory, operational, supply, and timeline risks, including clear recommendations, trade-offs, mitigations, and escalation plans.
• Drive harmonization, platform approaches, reusable standards, lessons learned, and best practices that strengthen Global QC capability.
• Mentor QC scientists and technical subject matter experts and communicate complex technical matters clearly to project teams and senior leadership.

• Bachelor’s degree with 16+ years of relevant industry experience, Master’s degree with 14+ years of relevant industry experience, or PhD with 8+ years of relevant industry experience in analytical chemistry, biochemistry, biological sciences, pharmaceutical sciences, chemistry, chemical engineering, pharmaceutics, or a related scientific discipline.
• Progressive scientific and Quality leadership experience in analytical development, Quality Control, analytical method validation, co-validation, method transfer, commercial analytical support, or related pharmaceutical or biopharmaceutical areas.
• Comprehensive knowledge of the analytical method lifecycle and the transition of methods from development into sustainable commercial QC execution.
• Strong knowledge of current Good Manufacturing Practice requirements, laboratory controls, data integrity principles, and regulatory expectations applicable to pharmaceutical QC.
• Demonstrated ability to solve complex scientific and operational problems and make timely, defensible, risk-based decisions.
• Demonstrated success leading complex cross-functional initiatives and influencing outcomes across a matrixed, global organization.
• Strong stakeholder management, organizational, and communication skills, including the ability to present recommendations, risks, decisions, and mitigation plans to technical and leadership audiences.