Supplier Quality Manager

Company: Kelly Services
Location: Kingston
Posted on: April 9, 2021

Job Description:

Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract--opportunity with one of our leading clients!--Title: Supplier Quality--ManagerLocation: RemoteDuration: --Long term--Overview

• The Global Supplier Quality (GSQ) organization leads Supplier Quality oversight for externally sourced materials to ensure that they align with the company's Quality Standard, are safe and effective and meet the required regulatory standards. We do this through execution of the key Pharmaceutical Quality System (PQS) and supplier management business processes, by experienced and qualified Quality Professionals.
• This role will also include the quality review and approval of Chemistry and Manufacturing Control (CMC) documents associated with changes or product establishment at suppliers.
• Key to this role will be maintaining a high level of understanding of relevant production processes and quality systems.--Responsibilities
  • Responsible for assuring the quality of materials received from the designated supplier portfolio and will proactively ensure GMP and regulatory compliance during supplier related projects.
  • Responsible for the Quality System oversight of Supplier related product quality complaints, change controls, deviation investigations, issue management and escalation, and Quality Agreements with External Suppliers; and the preparation and submission of Supplier Quality Risk Assessments, and support to Regulatory Agency inspections of supplier sites and site transfers.
  • Drive quality improvements at the supplier as part of a cross functional team
  • GSQ provides Quality oversight globally for approximately 1,600 supplier sites. The scope of the organization includes outsourced API, Biologics CMOs, Direct Materials including Devices, Formulation and Packing CMOs, Critical General Services, Contract Laboratories, Certification of Materials and the global IT System for Supplier Management.
  • Collaborate with colleagues and customers across many countries and interact cross-functionally with supply chain, supplier relationship, technical and project roles.--Required Qualifications
    • Degree in a science / technical field such as Pharmacy, Biology, Chemistry, Engineering, or equivalent experience
    • Broad experience with a minimum of 5 years relevant work experience in either the pharmaceutical operations environment or a pharmaceutical Quality Assurance role
    • Bilingual Spanish/ English speaking highly preferred
    • Excellent oral and written communication skills
    • Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment.
    • Strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.
    • Demonstrated experience working cross-functionally and leading significant improvement initiatives (e.g. project management skills)
    • Strong problem-solving and negotiating/influencing skills
    • Ability to work independently under your own initiative.
    • Ability to travel nationally and internationally as required up to approximately 10% of their time.--Preferred Qualifications
      • Experience working in a PCO/PET organization or Lean/Six Sigma training.
      • Multi-site / multi-functional experience - particularly within a manufacturing site environment.
      • Proven experience in Quality Assurance or combination of Quality and Technical.----Important information:--This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Taryn Carbone () for immediate consideration.Why Kelly--?Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.About Kelly--At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]]

Keywords: Kelly Services, Trenton , Supplier Quality Manager, Executive , Kingston, New Jersey