Full-Time

Quality Assurance Manager

Confirmed live in the last 24 hours

Sanofi

Sanofi

10,001+ employees

Global healthcare provider of pharmaceuticals and vaccines

Biotechnology
Healthcare

Senior

Edgewater, NJ, USA

Onsite presence required.

Category
QA & Testing
Quality Assurance
Required Skills
Word/Pages/Docs
Excel/Numbers/Sheets
PowerPoint/Keynote/Slides
Requirements
  • Bachelor's Degree in Life Sciences or Engineering
  • 6-7 years’ experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements
  • Flexibility with shifts. Primarily 1st shift however 2nd and 3rd shift presence when required
  • Advanced knowledge of MS Office including Excel, PowerPoint, and Word.
Responsibilities
  • Managing shopfloor team and day to day QA activities
  • Assist in enhancing the program and continuously improve
  • Establish walkthrough and audit scheduling and building support for both Sanofi locations
  • Drive the QA shop floor program and address concerns with manufacturing and driving quality improvements
  • Trend observations and drive proper actions to closure with manufacturing
  • Review findings with area owner and drive continuous improvement
  • Escalate results to management
  • Mentoring and coaching QA Shopfloor personnel
  • Coaching manufacturing team, when required
  • Collaboration with manufacturing on process improvements
  • Area/Line clearances, when required
  • Review documentation- BPRs, Logbooks
  • Deviation support, when required
  • Perform audits, walk-throughs, GEMBAs, technical coaching
  • Support Associate Director with task such as change controls, meeting coverage, deviations
  • Support Additional Quality functions (Media Fill Observer, Documentation Updates etc)
  • Author significant and non-significant deviations, change controls, report etc.
  • Present department KPIs as needed
  • Support other additional activities as needed (Management Review, presentations etc).
Desired Qualifications
  • Managing people, decision making, leadership, auditing, and deviation investigations
  • Demonstrated willingness to learn, teamwork abilities, excellent communication, adaptability, organizational and analytical skills, and a strong interest in the pharmaceutical and bio-pharmaceutical industry
  • Must have excellent written and verbal communication skills

Sanofi provides healthcare solutions through the development of treatments and vaccines. The company focuses on research and development to create new medicines and improve existing ones, particularly in areas like immunology, oncology, and rare diseases. Sanofi's products include prescription medications, over-the-counter items, and vaccines, which are distributed to patients, healthcare professionals, and governments. What sets Sanofi apart from its competitors is its strong emphasis on scientific innovation and extensive R&D efforts, supported by strategic partnerships and a diverse product pipeline. The goal of Sanofi is to enhance health outcomes and improve the quality of life for people globally by delivering effective and safe healthcare solutions.

Company Stage

IPO

Total Funding

$2B

Headquarters

Paris, France

Founded

1973

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Simplify's Take

What believers are saying

  • Tolebrutinib's FDA Breakthrough Therapy designation boosts Sanofi's neurology portfolio.
  • Dupixent's EU approval for young children expands Sanofi's pediatric market.
  • Sanofi's partnership with BrightInsight accelerates digital health solution development.

What critics are saying

  • Liver enzyme elevations in tolebrutinib patients may affect market acceptance.
  • Increased competition in rare diseases from biotech startups challenges Sanofi.
  • Regulatory delays could impact Dupixent's approval for chronic spontaneous urticaria.

What makes Sanofi unique

  • Sanofi's Care4Rare program supports innovative solutions for rare diseases.
  • The MyWay app enhances patient engagement and medication adherence.
  • Sanofi's Muse AI tool optimizes patient recruitment in clinical trials.

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Benefits

Health Insurance

Professional Development Budget

Parental Leave