QC Senior Specialist

Are you ready to lead complex QC investigations that safeguard life-changing medicines for people living with rare and devastating diseases? In this role, you will translate deep analytical expertise into decisive action—resolving critical issues, strengthening methods, and steering change controls that protect release and stability commitments.

You will be the technical anchor across our QC laboratories, aligning analytical test procedures across internal and external partners and driving sustainable improvements that reduce deviations and accelerate right-first-time outcomes. Do you thrive on bringing clarity to complex problems and guiding cross-functional teams through change with confidence and precision?

Accountabilities:
- Analytical Investigations Leadership: Lead and close complex QC analytical investigations and deviations, guiding laboratories to rapidly restore control and prevent recurrence.
- Risk and Escalation: Communicate status and risks to senior management with timely, data-driven updates and clear recommendations.
- Change Control Ownership: Initiate, manage, and drive complex change controls and CAPAs from scoping through implementation to sustained adoption.
- Cross-Functional Influence: Collaborate with manufacturing, quality assurance, development, and external laboratories to troubleshoot methods, improve robustness, and align practices.
- Subject Matter Expertise: Serve as SME for selected analytical chemistry, biochemistry, and/or microbiology methods, setting standards and mentoring colleagues.
- Technical Troubleshooting: Provide strategic and hands-on support to resolve method issues impacting testing, release, and stability timelines.
- Analytical Method Lifecycle: Support performance monitoring across the method lifecycle, turning trends into targeted improvements.
- Reference Standard Program Management: Manage the reference standard program to ensure availability, suitability, and control of standards.
- External and Internal Alignment: Ensure alignment of product analytical test procedures across internal sites and partner laboratories to maintain comparability and compliance.
- Operational Excellence: Deliver projects and improvement initiatives that increase laboratory efficiency and right-first-time performance, including APQR compilation and review.
- Governance Representation: Serve on change control review boards, assessing impact across products and coordinating effective implementation activities.
- Regulatory and Inspection Readiness: Support regulatory submissions and responses; maintain inspection readiness and actively participate in audits and inspections.
- Compliance: Perform all responsibilities in full compliance with cGMPs.

Essential Skills/Experience:

- Demonstrated experience managing complex analytical investigations and deviations within QC laboratories.
- Proven ability to facilitate communication on deviations, change control, and laboratory investigations.
- Track record managing and driving complex change controls and corrective actions (CAPAs).
- Delivery of project work and implementation of initiatives that improve laboratory efficiency.
- Recognized subject matter expertise in analytical chemistry, biochemistry and/or microbiology methods.
- Strong technical support capabilities, including method troubleshooting.
- Clear communication with senior management, with timely risk escalation.
- Experience leading cross-functional teams for complex change controls, method troubleshooting/improvement, and CAPAs.
- Experience supporting Analytical Method Lifecycle performance monitoring within QC.
- Support for laboratory operations including APQR compilation/review, change controls, investigation review, and process improvement.
- Ability to liaise with development and clinical supply teams to provide analytical test procedure information and data.
- Experience aligning product analytical test procedures across external and internal laboratories.
- Experience managing a Reference Standard Program.
- Service as a representative on change control review boards, assessing impact across products and managing implementation.
- Consistent performance in full compliance with cGMPs.
- Experience supporting regulatory submissions, requests, and responses.
- Active participation in audit/inspection readiness and in audits/inspections.

Desirable Skills/Experience:
- Experience with biologics and rare disease modalities.
- Expertise in method validation, transfer, and lifecycle management aligned to global guidelines.
- Proficiency with QC digital systems and data analysis for trend monitoring.
- Advanced root cause analysis and problem-solving tools (e.g., 5-Whys, fishbone, FMEA).
- Continuous improvement credentials or experience