Senior Manager, Global R&D Audits – Inspections Readiness

This is a fully remote position, open to applicants in United States.

📋 Description

• Conduct validation-by-design activities collaboratively with software engineering, product owners, and QA in an Agile/Scrum environment.

• Manage URS, FS, risk assessments, test evidence, traceability matrices, and documentation for release readiness.

• Ensure alignment of automated testing, CI/CD evidence, electronic records, and release controls with audit-ready verification standards.

• Implement delta-based validation for iterative feature enhancements.

• Establish and enforce GxP Definition of Done criteria.

• Lead initiatives for internal audits, mock inspections, inspection readiness exercises, and preparation for external health authority inspections.

• Develop technical inspection storyboards, system narratives, architecture summaries, data flow descriptions, evidence packages, and document retrieval plans.

• Mentor product owners, engineering subject matter experts (SMEs), vendors, and support teams on audit protocols and interview preparation.

• Assist in both front-room and back-room audit or inspection operations.

• Supervise externally sourced R&D IT systems, platforms, vendors, and SaaS providers to ensure compliance and inspection readiness.

• Facilitate vendor qualification, periodic reviews, compliance assessments, audit preparation, and evaluations of third-party deliverables.

• Oversee CSV/CSA execution for vendor-hosted or externally developed systems.

• Convert regulatory and quality expectations into actionable engineering and system lifecycle tasks.

• Aid in regulatory gap assessments and suggest remediation or process enhancements.

• Collaborate with Quality, Compliance, Security, and Enterprise IT on policies, SDLC checkpoints, and system controls.

• Manage CAPA, audit findings, remediation efforts, and gap closure activities.

• Track compliance KPIs, inspection readiness metrics, risk logs, platform readiness statuses, and issue updates.

• Provide status, risk, dependency, and decision updates to the Senior Director.

• Coordinate contributions from matrixed teams, vendors, SMEs, product owners, engineering resources, and quality partners.

• Guide stakeholders on validation-by-design, inspection communication, documentation quality, evidence readiness, and compliance execution.

⛳️ Requirements

• Bachelor's degree in Computer Science, Information Technology, Bioengineering, Life Sciences, Quality, Regulatory, or a related discipline.

• Over 7 years of experience in IT compliance, quality assurance, software engineering, systems validation, audit readiness, or related technology quality roles in the pharmaceutical, biotech, or medical device sectors.

• At least 3 years of experience in supporting audit/inspection readiness activities, mock audits, regulatory inspections, vendor audits, validation programs, CAPA execution, or compliance remediation.

• Hands-on experience in integrating GxP compliance within Agile/Scrum delivery, system lifecycle methodologies, validation documentation, test evidence management, and/or DevOps/CI/CD practices.

• In-depth knowledge of FDA 21 CFR Part 11, EMA Annex 11, GAMP 5 principles, CSV, CSA, ALCOA+, HIPAA, and GDPR.

• Capability to implement risk-based testing, delta validation, change impact assessments, requirements traceability, evidence reviews, vendor compliance evaluations, and inspection readiness practices.

• Familiarity with modern software delivery, cloud/SaaS platforms, externally sourced systems, AI/ML technology considerations, and regulated R&D data environments.

• Strong business relationship management skills and the ability to influence cross-functional stakeholders.

• Excellent documentation, communication, facilitation, issue management, and follow-through abilities.

• Proficient in managing relationships with direct, matrixed, vendor, and inspection support entities.

• Expertise in Agile, Scrum, Kanban, Lean methodologies, release readiness, audit preparation, and remediation tracking.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial roles.

• Discretionary equity awards.

• Option to voluntarily participate in the Employee Stock Purchase Plan.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance included.

• 401(k) retirement plan.

• Flexible Spending Account (FSA)/Health Savings Account (HSA).

• Life insurance coverage.

• Paid Time Off benefits.

• Access to a wellness program.

• Some travel may be required as part of assigned responsibilities.

• Reasonable accommodation available for applicants protected by applicable laws.