Sr Manager - Quality Compliance

Role Summary

The Sr Manager Quality Compliance plays a key role in ensuring compliance with GxP standards (GCP, GDP, GdocP, GLP, GMP, GPvP) across the product lifecycle from R&D through clinical phases to commercial launch and ongoing quality support. This role serves as the in-office Quality presence at the corporate office and coordinates with remote quality colleagues.

Responsibilities

• Inspection Readiness and Management and Support of Regulatory Inspections (clinical, preapproval, and routine inspections)
• Provide technical quality and/or strategic support to clinical sites and service provider sites to ensure inspection readiness and pre-approval inspections
• Lead and participate in mock inspections, internal audits, and other readiness activities
• Lead and support during the preparation, execution, and closure of health authority inspections; provide Quality representation in the Redwood City office to receive unannounced health authority inspections
• Support design, training, and execution of GxP inspection management processes and procedures; manage regulatory inspection responses within required time frames

Qualifications

• Bachelor‚Äôs Degree required
• Minimum of 9+ years of relevant experience including auditing, quality systems, and establishing/leading an inspection management programs
• Knowledgeable in industry practices, regulations, and guidance with experience with multiple health authorities (FDA, EMA, MHRA, etc.)
• Working knowledge of GxP Quality Management System fundamentals
• Familiar with all Quality Systems (Deviations, CAPA, Change Control, Controlled Documents, Complaints, etc.) and able to support or back up other Quality System Functions
• Understanding and impact of industry trends, regulatory compliance requirements, and best practices; benchmarking for Quality strategy
• Proven track record of developing and implementing audit and inspection management programs
• Proven track record of technical writing as applied to quality documentation
• Experience with validated systems such as Veeva or Trackwise; understanding of validation methodologies, regulatory compliance (FDA 21 CFR Part 11, Annex 11), and relevant industry standards
• Skilled at cross-functional collaboration with clinical and product supply
• Ability to lead, facilitate, and manage cross-functional teams of internal and external stakeholders
• Strong analytical and problem-solving capabilities; use innovative approaches to complex problems
• Ability to facilitate multifunctional teams and present data to internal/external audiences including Regulatory Agencies
• Sense of urgency, initiative, and strong teamwork and collaboration skills
• Proficient in MS PowerPoint, Word, and Excel
• Strong presentation and communication skills across organizational levels
• Strategic thinking and ability to translate strategy into actions
• Willingness to work in a dynamic and changing environment
• Acts as a role model in living Rezolute values