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Manager, Quality Auditing (Post Audit)

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Apr 3, 2024

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Job Details

We are currently looking to fill a Manager, Quality Auditing (Post Audit) position. This position is responsible for providing professional expertise, leadership, oversight and assisting with planning for the Regeneron Quality Auditing function. Quality (GMP) Auditing is responsible for maintaining the external audit programs and may perform external audits for Regeneron, with primary emphasis on GMP, IT and Quality audits that may impact GMP operations and/or products.

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

  • Leads the GMP Auditings Post-Audit Team who is responsible for evaluating auditee responses, reviewing and approving post-audit documents (e.g., comments letters, response acceptance letters, audit closures, CAPAs)

  • Maintains 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 (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards and ICH, WHO and IPEC Guidelines, etc.)

  • Monitors and communicates industry trends as they pertain to regulatory agency findings, expectations and warning letters

  • Partners with external organizations (e.g., Suppliers) and internal team members (e.g., Procurement, Drug Product Quality, External Manufacturing, QA & Operations, QPs, Audit Clients, etc.)

  • Develops strategies to achieve what needs to be done; prioritizes and coordinates resources to meet post-audit team, department and company goals

  • Provides direction on audit responses and CAPAs, and provides leadership and supervision to GMP Auditing Post-Audit Team personnel; promotes a GxP and Quality approach

  • Schedules, plans and assigns post-audit activities; may participate in audits

  • May assist with the selection, training, onboarding, performance assessments and audit performance of external proxy auditors (consultants)

  • Coaches, develops and mentors Quality Auditing (GMP) employees to drive succession planning and business continuity planning

  • Develops and maintains metrics for areas of responsibility to measure strategy and test the health of Quality Auditing systems and processes; compiles, coordinates, and may present metrics to department and site leadership

  • Ensures processes meet the minimum regulatory requirements and current industry standards, ensures expectations and procedures are followed, and ensures deviations and changes, if any, are detailed and assessed within company guidelines

  • Works in and on the business; translates ambiguity into steps and prevents deviations and fires using effective and out of the box problem solving

  • Reassesses auditing processes and procedures periodically for continuous improvement opportunities to ensure efficient performance and compliance

  • Ensures the training and qualification program for GMP Auditing personnel is appropriate and adequately maintained

  • Accountable for the performance and results of the team; may lead people who supervise others

  • Participates in inspection readiness and inspections as needed

  • Ensures safety and operational standards are maintained

  • Leads and/or participates in projects and initiatives as assigned by management.

This role may be for you if you:

  • Are an authority in GMP supplier quality auditing

  • Have 2 years managerial experience

  • Thrive in a quality focused environment

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

  • Are able to travel approximately 10% of your time, domestic and international

To be considered for this role you must hold a Bachelors degree in Life sciences or related field with the following amount of related experience in the pharmaceutical/biotechnology industry, including experience with Quality Systems and auditing:

  • Manager 7+ years

  • Sr Manager 8+ years

Level is determined based on qualifications relevant to the role. May substitute relevant experience in lieu of educational requirements.

#REGNQA

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)

$101,800.00 - $194,200.00

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
US

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