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Director, Investigations (Systems)

Job Description

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We are currently looking to fill a Director, Investigations (Systems) position. This position is responsible for providing direction and oversight to the review, approval and management of investigations and corrective and preventive actions.

In this role, a typical day might include the following:

  • Leads a team with direct oversight of review and approval for GMP Documents

  • May review, verify and approve system records

  • Collaborates cross functionally to provide succinct support to teams to strive to quality outcomes

  • May approve and review Policy/SOP revisions

  • Provides direction for cross-functional teams. Serves as an escalation point as well as determination when additional escalation is required

  • Identify leading practices and recommend improvements to continuously improve compliance profile

  • Serves as a subject matter authority (SME) to present topics to management and during inspections

  • Supervises relevant quality system metrics including deviations and corrective actions. Uses metrics to identify and pursue initiatives

  • Drafts and implements long-term planning for the process and staff

  • Performs personnel management functions (i.e. annual employee evaluations, coaching, mentoring, performance feedback, etc.)

  • Makes decisions and develops and implements policies.

  • Ensures that policies and procedures are effectively administered and align with regulatory requirements and current good manufacturing practices (cGMPs)

  • Participates on internal committees/teams, as required

This role might be for you if you:

  • Have experience leading a large team of quality minded individuals

  • Continuously seek to improve processes for improved performance

  • Have detailed knowledge of cGMPs

  • Excel in a quality driven organization

  • Have an understanding of biologics manufacturing operations

To be considered for this role you must hold a Bachelor’s degree in Life Sciences or related field and the following amount of relevant cGMP manufacturing experience for each level:

  • Associate Director – 10+ years

  • Director – 12+ years

Level to be determined based on qualifications relevant to the role. May substitute proven experience for education requirement.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$142,700.00 - $277,100.00