Posted 15 June 2022
LocationUnited States of America
Job type Full Time
DisciplineMedical Devices

Job description


Mantell Associates is currently partners with a TOP 3 global leader in the Biologics CDMO space based in the USA.

• Are you looking to join a leading global CDMO that is backed by and the strongest arm of the #1 organization across the planet?

• Are you experienced with In Vitro Diagnostic in Medical Devices Manufacturing?

If you’ve answered yes to any of those questions, you will get the opportunity to work alongside industry leaders and join a diverse and forward-thinking culture!

You Will be Responsible to (including but not limited to):

• Report to top management on the performance of the QMS, including needs/ideas for improvement, and promotes awareness of regulatory and customer requirements throughout the organization; serves as the management representative to external regulatory agencies; drives improvement activities and maintains comprehensive Quality metrics

• Develop, manage, and maintain the site Quality Management System (QMS) in accordance with applicable Regulatory requirements (US FDA 820, MDSAP, IVDR and any other applicable regulations) and International Quality Standards (ISO 13485 and any other applicable standards); exercise the authority and the responsibility to implement and maintain an appropriate QMS

• Lead, manage, and develop the Quality Assurance (QA) and Quality Control (QC) functions to ensure product realization and maintenance of the QMS; ensure implementation of team objectives aligned with Corporate, Site Quality, and business goals; direct and oversee all department staff in the performance of their respective duties, and complete related HR activities including interviewing, performance management, and disciplinary tasks

• Partner with Manufacturing, Regulatory Affairs, and other related support teams to make recommendations, set goals, and implement solutions for process improvements and maintaining compliance. Provides overall guidance on Quality and ensures business objectives are met

• Ensure that manufacturing and testing operations conform to applicable quality standards, regulations, and customer/regulatory specifications by implementing the necessary systems, procedures, documentation, and training to maintain compliance

• Ensure that approved product, process and raw materials specifications, quality and regulatory requirements are met; be responsible for all products released into inventory; exercise authority to place product on hold, or prevent shipment of product, where a product quality concern has been raised

• Ensure that site staff understand and comply with applicable Quality standards and regulatory requirements including identifying training needs, developing training materials, and providing training and support to site staff

• Promote awareness of regulatory and customer requirements throughout the organization

• Cultivate a site culture of compliance excellence and continuous improvements; provide expert guidance and consultation to operations management in the areas of compliance and industry expectations

• Act as the Person Responsible for Regulatory compliance as applicable for site IVDR certification requirements

Who You Are:

Minimum Qualifications:

• Bachelors degree or higher in a scientific discipline

• 7-12 years’ experience leading teams within a quality organization in a technical manufacturing environment.

• Demonstrated command of Quality Management Systems (QMS) supporting ISO 9001, and ISO 13485 certifications as well as FDA regulations (such as CFR820) in support of medical device class I-III products and EU IVDR Regulations.

• CQE, CQA, CQPA, CBA, CMQ/OE certifications strongly preferred

Preferred Qualifications:

• Exceptionally strong leadership skills

• Strong foundation in Lean Manufacturing and Continuous Improvement; LSS Black or Green Belt certification strongly preferred

• Proven problem-solving ability with ability to engage root cause analysis

• Exceptional organizational skills

• Ability to motivate and build a high performing team

• Strong written and verbal communication skills

• Collaborative team player with ability to drive change and challenge the status quo

• Ability to set ambitious and achievable targets to drive results based on organizational objectives

Mantell Associates is a specialist Pharmaceutical and Life Sciences Headhunting firm. For more information on this role, please contact Vivek Patel at vivek.patel@mantellassociates.com