Director, GPS Quality & Compliance

BioSpace; New Jersey; On-site; USD 183,000 - 305,000; Full time

Job summary

Regeneron is seeking a Director, GPS Quality & Compliance to lead quality event management and inspection readiness initiatives. The role collaborates with GPS leadership, Global Development Quality, and the QPPV Office to ensure timely, high-quality program delivery.

Based in Warren, NJ (preferred) with 4 days on-site work and ~20% travel, the position governs GCP/GVP audits and inspections, driving data-driven decisions and tight regulatory alignment across DGQ and vendor relationships.

Qualifications

• This role requires deep knowledge of global PV regulations and inspection readiness.
• Experience facilitating FDA/EMA inspections and serving as an inspection point of contact.
• Strong governance, metrics programs, and cross-functional quality oversight.

Responsibilities

• Lead quality event management and inspection program workstreams.
• Serve as a trusted point of contact during audits, guiding teams through preparation and responses.
• Maintain inspection readiness materials and translate regulatory frameworks into action.
• Champion accountability and continuous improvement across teams.
• Review quality metrics to provide actionable leadership recommendations.
• Present governance topics and quality insights to senior leaders.
• Coordinate across teams and functions, influencing without formal reporting lines.

Skills

Quality event management

Inspection readiness

Audit leadership

Regulatory knowledge

Cross-functional leadership

Education

Bachelor's degree

Advanced degree

Tools

GxP systems

FDA CFR knowledge

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Our Global Patient Safety (GPS) organization is seeking a Director, GPS Quality & Compliance to support our quality event management and inspection readiness programs. This role partners closely with the Senior Director, GPS leadership, Global Development Quality, and the QPPV Office, and operates as a functional leader who coordinates and delegates work across the team to ensure consistent, high-quality program delivery.

This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & Where

• Location: Warren, NJ (preferred), Armonk or Tarrytown, NY, or Cambridge, MA
• Work model: 4 days/week on-site
• Travel percentage: 20% with some fluctuation expected based on onsite audit/inspection support needs.

Discover Your Role

• Lead functional workstreams across quality event management and inspection programs, coordinating and delegating work across a team
• Serve as a trusted point of contact during GCP and GVP audits and inspections, guiding teams through preparation and real-time response
• Bring order to complexity by maintaining inspection readiness materials and translating regulatory frameworks into practical action
• Champion a culture of accountability and continuous improvement, acting as an escalation point when issues arise
• Turn data into direction, reviewing quality metrics and trend analyses to shape clear, actionable recommendations for senior leadership
• Communicate with confidence and clarity, presenting governance topics and quality insights to senior team members
• Lead through influence, coordinating across teams and functions regardless of formal reporting lines

This Role Requires

• A Bachelor's degree required; advanced degree preferred with a minimum of 12 years of pharmaceutical industry experience; Healthcare Professional background preferred
• Deep knowledge of global PV regulations, quality management systems, and inspection readiness frameworks (FDA CFR, GVP Modules)
• Demonstrated experience facilitating FDA and EMA/MHRA inspections (GCP and GVP), including direct experience as an inspection point of contact
• Proven track record overseeing QMP governance, metrics programs, and cross-functional quality oversight
• Experience managing relationships across GDQ, QPPV Office, Regulatory Affairs, and vendors

People Management Experience Preferred

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, 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, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Salary Range (annually)

$183,100.00 - $305,200.00

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.