Regeneron Pharmaceuticals
Senior Manager QA Auditor GCP Strategy
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Senior Manager QA Auditor GCP Strategy
Senior Manager, GCP Audit Strategy, Global Development
Location: UK (Remote) / Ireland (Remote) – 10–20% travel may be required
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We’re seeking a Senior Manager, GCP Audit Strategy in Global Development Quality Assurance (GDQA) to lead auditor risk-based strategy programs, oversee compliance across therapeutic areas, studies, and audit activities—fully remote.
About the Role
You’ll strategically shape audit planning and execution to drive compliance while collaborating with Global Development teams, auditors, and cross-functional stakeholders. As part of a fast-growing, science-driven organisation, your work will directly impact patient care worldwide.
Key responsibilities include:
- Lead risk-based audit strategy programs, leveraging study teams’ risk indicators
- Ensure audits align with approved timelines and approved programs
- Manage audit outcomes, identify trends, and communicate risks to leadership
- Represent Quality Assurance on complex cross-functional initiatives
- Deliver actionable audit reports and performance metrics to Global Development leaders
- Strengthen stakeholder engagement across global functions while prioritising ambiguous, high-impact tasks
Responsibilities
- Audit Strategy & Planning
- Design and implement risk-based audit programs across therapeutic areas and studies
- Lead proactive risk-assessments using study team inputs to refine audit scopes
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Compliance Oversight
- Align audits with regulatory expectations (FDA, EU, ICH GCP)
- Ensure timelines and programs meet agreed deliverables
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Trend Analysis & Reporting
- Analyse audit trends to identify systemic compliance risks
- Communicate findings to senior leadership and cross-functional teams
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Stakeholder & Cross-Functional Collaboration
- Partner with regulatory, clinical operations, and project management teams
- Facilitate transparency and continuous improvement initiatives
Requirements
- Education: Bachelor’s degree (preferably in Life Sciences, Pharmacology, or related fields)
- Experience:
- 8+ years in pharmaceutical/biotech quality assurance
- 5+ years in GCP audit strategy or audit execution
- Regulatory Knowledge:
- Strong grasp of FDA, EU, and ICH GCP guidelines
- Hands-on experience supporting regulatory inspections
- Technical Skills:
- Proven project management expertise for complex audits
- Exceptional stakeholder management with senior SMEs
- Communication:
- Strong written and verbal skills (+confidence presenting at executive level)
Why Regeneron?
- A science-driven, patient-focused environment
- Remote flexibility (select roles) with potential limited travel
- Meaningful impact: We pioneer nine FDA-approved life-changing medicines
- Culture: Ranked among the Great Places to Work (2021), a global leader in innovative healthcare
- Competitive Benefits:
- Annual bonuses, equity awards, and global pension/RRSP plans (country-specific)
- Access to on-site fitness centres, wellness programs, and expansive insurance packages
- Generous paid time off, family support, and flexible work policies
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N.B.: Some roles require hybrid/onsite attendance. This role is fully remote; travel forming only 10–20% of duties.
Our Commitment to Diversity & Inclusion
Regeneron fosters an inclusive workplace, where every voice matters. We welcome applications from diverse backgrounds and are committed to providing reasonable accommodations to qualified applicants with disabilities (subject to undue hardship laws).
Ready to drive a brighter future? Apply today.
Apply Now (hiring page)
『Regeneron is an equal opportunity employer. eragad वाली सहभागिताकरी”
Note: In Canada, this role adheres to existing labour market needs. All salary ranges and benefits described are country-specific; USD/CAD packages vary by negotiation. For US-based rewards, visit regeneron.com/careers.
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