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Associate Director QA Auditing

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Sep 7, 2022

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Discipline
Quality, Quality Assurance
Required Education
Bachelors Degree
Position Type
Contract
Hotbed
Pharm Country, Best Places to Work

Job Details

The Regeneron Associate Director QA Auditing-GLP is a key position in the Quality Assurance and Auditing group and will provide professional expertise, guidance, and leadership for the GLP Audit Program. This individual will create strategic partnerships and direct risk-based quality auditing activities across Preclinical Development (GLP). This individual applies expertise in Good Laboratory and international regulations and guidelines to the auditing process to independently address a variety of compliance issues associated with drug development. This individual is responsible for ensuring auditors have the education, experience and/or training necessary to be able to identify compliance issues and negotiate resolution in a highly autonomous manner.  The individual should have an expert knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect drug development including HIPAA Privacy Rule, and other international and national rules as applicable. Manages the GLP audit function within the Quality Assurance and Auditing organization.

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

•     Maintain professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines.

•     Responsible for departmental and/or project related results, costs, methods, staffing, managerial planning and integration

•    Applies expert-level understanding of discipline/specialization and advanced interpersonal    and communication skills.

•    Manages resources & staff to accomplish the annual audit schedules.

•    Conduct audits as needed.

•    Responsible for managing and developing direct reports, providing leadership, guidance, and supervision as required.

•    Assess and prioritize both internal and external audit needs.

•    Liase with Quality Assurance and cross functional teams to facilitate the adequate closure of audits.

•    Represent QAA on teams, compliance projects and initiatives both within and across functional areas of Preclinical and Global Development to ensure compliance with related regulations and internal procedures.

•    Escalates compliance risks to Executive level management as needed.

•    Assist in the selection, training and overseeing the onboarding of contract auditors, as needed.

•    Drafts and issues periodic area metrics reports to management, cross functional groups and leadership teams as requested.

•    Delegate, as necessary, tasks and duties to other functional staff.

•    May assist in the conduct and act as a subject matter expert in regulatory facility inspections.

•    Ensure succession planning and business continuity for the GLP audit function.

This role might be for you if:

  • Bachelor’s degree ( Master’s degree preferred) with 12+ years of relevant industry experience
  • 10+ years’ experience working in GLP auditing and 5+ years prior supervisory/leadership experience required.
  • Excellent communication skills and ability to work with people in all levels of the organization and externally.
  • Demonstrated skills in taking initiative and working independently
  • Experience with FDA or other Regulatory Inspections of Sponsors or CROs.
  • Demonstrated experience in driving Quality into the GLP Operations processes
  • Self-motivated with the ability to work effectively in a dynamic environment with ambiguity
  • Strong leadership with demonstrated ability to interface with senior leaders
  • Good problem solving, written and verbal communication skills
  • Ability to effectively manage multiple priorities with a sense of urgency
  • Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
  • Attention to detail and accuracy of work

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 amazing benefits including health and wellness programs, fitness centers and stock for 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.

#GDRAJobs

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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