Manager, Quality Assurance Collaborations

We are currently looking to fill a Manager, QA Collaborations position. This position is responsible for establishing and maintaining Quality relationships with external partners and support internal operations to facilitate those relationships.

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

• Leads a team with direct involvement in the establishment of the quality relationship elements between Regeneron and other firms. Examples of this include:

  • Establishing Quality Assurance Agreements

  • Creating ways of working

  • Providing a single point of contact for other firms to use in navigating quality issues.

  • Engages with CMC Program Management, Alliance Management, and appropriate technical teams to lay the infrastructure to support new technologies and platforms.

• Leads a team with direct involvement in driving the operational efficiency of departments. Examples of this include:

  • Developing systems to track the timeliness of operations and identify areas of critical issue.

  • Run the operation to a standard lead time

• May review, verify and approve records on a limited basis with a focus on new relationships.

• Collaborates across the business to support the core duties and responsibilities.

• Seeks to identify gaps in the current business in order to design it to support new technologies and partners. These gaps may both in technical experience and procedural governance.

• Approves and reviews SOP revisions. Provides guidance on regulatory expectations of new technologies.

• Presents topics to management and during inspections.

• Reviews quality system metrics including deviations, corrective actions, changes and controlled document workflows. Uses metrics to identify and pursue initiatives.

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

• Makes decisions and develops and implements policies.

This role may be for you if you:

• Thrive in a quality focused environment

• Have comprehension of quality and cGMP principles

• Are experienced in Project Management principals

• Possess excellent written, oral, and interpersonal communication skills with ability to effectively interact with a broad spectrum of audiences

To be considered for this role you must hold a Bachelor’s degree in a scientific subject area or related field with the following amount of related experience in a pharmaceutical / biologics cGMP environment for each level:

• Associate Manager – 6+ years

• Manager – 7+ years

• Sr Manager – 8+ years

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

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)

$86,900.00 - $194,200.00