Regeneron
Senior Manager QA Auditor GCP Strategy
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Senior Manager QA Auditor GCP Strategy
Senior Manager, GCP Audit Strategy, Global Development
Build Our Future Together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, GCP Audit Strategy, Global Development to join our Global Development Quality Assurance (GDQA), supporting the Global Development organization in a remote work mode.
When & Where
- UK Remote
- Ireland Remote
Discover Your Role
In this role, you will:
- Lead risk-based audit planning across therapeutic areas and studies
- Drive strategic audit programs using risk indicators from study teams
- Ensure audits align with approved programs and scheduled timelines
- Manage audit outcomes to identify trends and communicate risks
- Represent quality assurance on complex cross-functional initiatives
- Deliver reports and metrics to Global Development leadership
- Collaborate with stakeholders across global functions
- Navigate ambiguity while prioritising multiple complex activities
Please note that up to 10-20% travel may be required.
Requirements
- Bachelor’s degree with 8+ years of relevant industry experience
- 5+ years of GCP audit strategy or audit experience
- In depth knowledge of FDA, EU, and ICH GCP regulations and guidance
- Experience supporting or participating in regulatory inspections
- Strong project management and stakeholder management capabilities
- Excellent written and verbal communication skills with senior audiences
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Inclusion & Benefits
We are committed to building an inclusive workplace. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration without regard to:
- Race
- Colour
- Religion or belief (or lack thereof)
- Sex, sexual orientation, gender identity or expression
- Gender reassignment
- Marital or civil partnership status, civil status, pregnancy or parental status
- Age
- Disability
- Nationality, citizenship status
- Ethnic or national origin
- Membership of the Traveler community
- Familial status
- Genetic information
- Military or veteran status
Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodations impose undue hardship.
Salary & Total Rewards
Regeneron offers a competitive and comprehensive total rewards package, which may include:
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
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Additional Notes
- The final offer will be determined within the relevant salary range based on the country of employment, the specific role level, and your skills and experience.
- In some countries, collective bargaining agreements (CBAs) may apply and influence elements of pay or benefits.
For additional information about Regeneron benefits:
- US employees: Working at Regeneron (Total Rewards)
- Other locations: Details provided during the recruitment process
Please note that whilst many roles at Regeneron may be remote, certain positions may require on-site work. Please speak with your recruiter and hiring manager for details regarding your specific role and location.
Background checks may be conducted for verification during the recruitment process, including identity, right to work, and educational qualifications.
For Canada-based positions: this listing relates to an existing role.
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