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External Audit Manager, Supplier Quality - Vaccines

date posted 08/15/2022
contract type Full time
job id R2644188
location Swiftwater, Pennsylvania

This position predominantly manages quality, GxP audits, and related investigations of material and service suppliers supporting our vaccine manufacturing operations. 

KEY ACCOUNTABILITIES

Auditing

  • Conducts planned and unplanned external audits to ensure suppliers meet global and local requirements

  • Supports the global auditing network by providing site-related information and assessing audits performed by other entities

  • Writes audit reports and updates the global database within the required KPIs

  • Proactively follows up with supplier for proposed CAPA plan and escalate as needed

  • Initiates risk assessments and provides support to end-users

  • Interacts with Sanofi’s global and regional network

  • Manages the supplier’s portfolio within the global database

  • Can expect to travel up to 40% of the time throughout North America with the possibility for short periods ranging up to 80%

Supplier Related Investigations

  • Directly interfaces with internal stakeholders to support the investigation process

  • Proactively follows up with suppliers to get the required information

  • Communicating with the investigation team and management, attending ad-hoc meetings, and monitoring associated CAPAs within the required KPIs

Department Representative Support

  • Supports change control works

  • Reviews and approves technical specifications

  • Facilitates and updates required legal documents (CDAs, QTAs)

  • Attends internal and external meetings as Supplier Quality representative

  • Supports team members as backup

Inspection Readiness

  • Always acts in compliance with local and global requirements

  • Maintains records and systems to support site regulatory and corporate audit activities

  • Provides support during regulatory inspections as part of the inspection team or Supplier Quality representative

ADDITIONAL ACCOUNTABILITIES

  • Manages training requirements and KPIs for the department

  • Participates in continuous improvement activities for Supplier Quality

  • Performs gap remediation assessments for new or updated Global directives

  • May support Supplier Change Notification oversight

TECHNICAL COMPETENCIES

  • Strong understanding of Quality Management Systems and Aseptic Manufacturing Processes

  • Adherence to aggressive timelines

  • Autonomy

  • Ability to multitask and prioritize effectively

  • Ability to process large amounts of information/data in short periods of time

  • Successful communication, organization, and planning skills

  • Strong Project Management skills (planning, follow up, documentation, time management)

REQUIREMENTS:

Education:

  • Minimum bachelor’s degree in a scientific field preferred, with at least 5 years of relevant pharmaceutical industry experience -or- 10 years of quality auditing experience in a regulated industry

Certifications:

  • ASQ or other quality-related certification is desired

Location:

  • Job is based in US/Swiftwater, PA. This is considered a hybrid position allowing the individual to work remotely for up to 50% of the time during routine activities.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

Fully vaccinated, according to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. 

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.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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