Sanofi Group Manager Research & Development Quality Assurance US, Swiftwater, PA in Swiftwater, Pennsylvania

SUMMARY OF PURPOSE/MAJOR RESPONSIBILITIES

This position primarily supports quality management and compliance activities, and risk management, associated with clinical testing operations within Sanofi Pasteur Global Clinical Immunology (GCI) Laboratories. In this role, the incumbent will:

  • Ensure clinical trial samples are tested in accordance with GCP, GCLP, related global and local procedures to assure clinical data integrity and safeguard patient safety

  • Conduct risk –based GCLP internal and third party audits against an established schedule.

  • Support implementation and assessment of relevant site and global quality systems, including event management, CAPA and changes

  • Participate in local and global quality initiatives and continuous improvement activities

  • Exercises sound judgement in planning, organizing and performing independent quality assurance activities with effective collaboration within R&D SQO and stakeholders

KEY ACCOUNTABILITIES

  • Coordinate and conduct independent GCLP quality audits of clinical laboratories within Swiftwater operations

  • Plan and conduct third party audits to ensure their compliance against applicable regulatory requirements and Sanofi policies and procedures

  • Provide support in implementing risk based audit process to ensure effective audit program

  • Ensure integrity and quality of clinical data generated within the laboratories through routine study audits in consistent with clinical trial protocols

  • Provide quality support for preparing the laboratories for regulatory inspections and in conduct of regulatory inspections

  • Ensure appropriate quality system is maintained through quality review of deviations, change controls, training program verifying effective implementation of CAPAs

  • Provides quality support for routine quality management reporting in order to ensure deliverables, actions and timelines are met

  • Participates in cross-functional teams with respect to GXP compliance and continuous improvement

CONTEXT OF THE JOB/MAJOR CHALLENGES

  • The incumbent is responsible to ensure quality and compliance risks associated with testing of clinical trial samples in accordance with GCP, GLP and GCLP standards, guidelines, and regulatory and internal requirements. Familiarity with laboratory testing processes is fundamental in performing this role. A strong working knowledge of immunochemistry test methods and their qualification/validation requirements are key for auditing, identifying and investigating deviations or deficiencies to standards, specifications and processes. Investigations involve root cause analyses that lead to implementation of corrective and preventative actions (CAPA) to restore compliance status of the errant process

  • This position requires a strong understanding of quality, and team leadership attributes as the incumbent will interact with individuals/professionals/auditors from various R&D and IA functions to resolve problems or implement quality systems. The incumbent will also interact with other R&D SQO auditors and corporate (or third party) auditors during audits related to R&D activities. An ability to negotiate and communicate with relevant people in a positive manner while identifying, discussing, and rectifying problems is a requirement of the position

  • The ability to facilitate and prioritize quality issues identified within the laboratories in a timely fashion requires flexibility, constructive and/or innovative thinking, and sound judgement to be able to apply independent quality assurance and maintain active collaboration and partnership with R&D stakeholders

  • Decisions the incumbent may make are based on multiple sources that will require investigation and/or interpretation. Work consists primarily of duties requiring resolution through the choice of several learned policies and procedures with respect to analytical and quality assessments. The incumbent will be required to actively balance the quantity of their work with an acceptance level of quality while ensuring compliance

DIMENSIONS/SCOPE

  • The position generally operates both in an office and laboratory setting. The office environment requires intense concentration and visual examination of documents

  • The position may require a particular vaccination for the areas of responsibility

  • The position requires that the incumbent interact with R&D colleagues as a representative of R&D SQO on a consultant/expert basis

  • The position may require a minimal amount of travel

  • The number of documents reviewed and approved annually is dependent on the volume of activity within GCI R&D. The incumbent will be expected to reliably and consistently evaluate the compliance of each document to established standards, guidelines, and regulatory and internal requirements to approve the documents

BASIC REQUIREMENTS:

Education/Certifications

  • Minimum Bachelor of Science Degree, specializing in Biology, Microbiology, Biochemistry, Engineering Sciences or similar discipline

  • ASQ Certified or ISO Certified Auditor qualification or Quality System certification training from a recognized institution are assets

Experience

  • 3-5 years related experience in the Pharmaceutical Industry

  • Excellent problem solving, report writing and communication skills based on global interaction

  • Excellent knowledge of compliance standards under GXP, including basic principles of GMP for US, Canada and Europe. Knowledge of GCP an advantage

  • Ability to work and influence in a team environment

PREFERRED REQUIREMENTS:

Education

Master of Science Degree, specializing in Biology, Microbiology or Biochemistry

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SP

#LI-SP

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life