Quality Manager III

Kelly Services is looking for a Quality Manager III in Raritan, NJ

Pay rate 52/hr

Project duration is two years with high possibility to extend to third year.

Initial phase of the project will involve working out of a North Jersey location at least 50% of the time.

Remainder of the time can be remotely.

Occasional face-to-face team meeting with team may occur onsite in Raritan,

Titusville or Horsham, PA.

While production campaign is going, extended work day may be required to provide oversight (8/hours per workday). 

Description:

  • This position will lead the following activities to provide Quality Oversight for Tech Transfer and Validation activities.
  • Ensure quality and regulatory compliance of the tech transfer process.
  • Review/approve documentations (validation, regulatory submissions, etc.) against product requirements.
  • Direct audit and risk management programs to maintain site qualification.
  • Oversees the execution of Quality Systems (Purchasing controls, validation, audits, change controls, etc.).
  • Support Regulatory Submissions activities.
  • Lead readiness program in coordination compliance, development team and project team.
  • Maintain quality agreements and specifications changes. Drive continuous improvements and design quality into the process.
  • Monitor trends, identify risk, troubleshoot, escalate to senior management as necessary.
  • Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence.
  • Participate and lead audits of external manufacturers.
  • Ability to apply regulations to all aspects of the manufacturing and tech transfer process.

Requirements

  • Strong leadership and negotiation skills are required.
  • Ability to lead and influence in a team environment with no direct authority is critical.
  • Strong communication skills and organization skills are required.
  • Position requires frequent travel to external manufacturer sites to provide quality oversight.
  • Experience in the development and implementation quality systems is required, including risk mitigation plans, nonconformance and change controls.
  • Bachelor’s Degree in Science with a minimum of 10 years in a FDA regulated environment is required; with a strong a pharmaceutical/biologics manufacturing or quality environment.

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations— providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

About Kelly Services®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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