Senior Manager, Global R&D Audits & Inspections Readiness

Location: Remote (US)

Salary: $147,800–$192,800 annually

Company

hirify.global is a global biopharmaceutical company focused on discovering and developing innovative drug therapies for cancer treatment.

What you will do

• Execute validation-by-design activities across R&D products, systems, vendors, and SaaS platforms.
• Coordinate validation deliverables including requirements, specifications, risk assessments, test evidence, traceability matrices, and release readiness documentation.
• Lead audit, mock inspection, and regulatory inspection readiness workstreams, including technical storyboards, evidence packages, and retrieval plans.
• Support front-room and back-room inspection operations, SME preparation, response tracking, and follow-up documentation.
• Translate regulatory expectations into Agile, SDLC, CI/CD, data integrity, security, and operational controls.
• Track CAPA, audit findings, remediation actions, compliance KPIs, risk logs, and readiness dashboards.

Requirements

• Bachelor’s degree in Computer Science, Information Technology, Bioengineering, Life Sciences, Quality, Regulatory, or a related field.
• 7+ years of experience in IT compliance, quality assurance, software engineering, systems validation, audit readiness, or related technology quality roles in pharmaceutical, biotech, or medical device environments.
• 3+ years of experience with audit or inspection readiness, mock audits, regulatory inspections, vendor audits, validation programs, CAPA execution, or compliance remediation.
• Practical experience embedding GxP compliance into Agile or Scrum delivery, lifecycle practices, validation documentation, test evidence management, or DevOps and CI/CD workflows.
• Strong knowledge of FDA 21 CFR Part 11, EMA Annex 11, GAMP 5, CSV, CSA, ALCOA+, HIPAA, and GDPR.
• Strong documentation, communication, facilitation, risk management, stakeholder coordination, and issue-tracking skills.

Nice to have

• Advanced degree or certifications such as CQA, CMQ/OE, CISA, ScrumMaster, or Product Owner.
• Experience with cloud and SaaS platforms, AI/ML considerations, externally sourced systems, and regulated R&D data environments.

Culture & Benefits

• Collaboration across engineering, product, Quality, Compliance, Enterprise IT, Security, vendors, and R&D stakeholders.
• Execution within a quality-first, risk-based, and inspection-focused operating environment.
• Some travel is expected as part of assigned duties.
• Benefits include medical, dental, vision, 401(k), FSA/HSA, life insurance, paid time off, and wellness programs.
• Eligibility for annual bonus participation, discretionary equity awards, and the Employee Stock Purchase Plan.