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Associate Director / Sr. Quality Compliance Manager -

Company: Yoh, A Day & Zimmermann Company
Location: Berlin
Posted on: February 23, 2021

Job Description:

Associate Director / Sr. Quality Compliance-Manager--

NEED STRONG Quality Control within a Biologic environment!!


  • Client is a Life Science very successful-late stage start-up.- Less than 200 employees
  • Firm focus is tissue analysis from discovery through clinical and translational research, enabling the development of more precise therapies for immuno-oncology and other drug development applications.
  • Location: Marlborough, MA
  • Full-time,
  • Remote to Start, 3-4 days on site in future



    Qualification/Experience/Skills


    Bachelor's degree, minimum 8 years of experience in a quality-related role in Biologics, In-vitro diagnostics, or Medical device industry, plus 3 years in people management and Quality management.
    Expertise in QC method development and qualification and microbiological techniques. Knowledge of analytical techniques associated with testing and release Biologics and reagents preferred.
    Strong technical understanding of complex analytical techniques, including HPLC/UPLC, CE, MS, UV, and gel electrophoresis. Experience managing contract laboratories, preferred
    Demonstrated knowledge of Quality Systems and cGMP within FDA-regulated environment. Experience in electromechanical instruments preferred.
    Understanding of the process of New Product development and regulatory submission 510(k), IDE and PMA
    Travel Requirements 5-10%
    Understanding of regulatory requirements related to advertising and promotion for products.


    ROLE

    Reporting to the Head of Quality, Associate Director / Sr. Manager of Quality is responsible for ensuring procedures, systems, and processes effectively meet Quality requirements and business needs for product development through commercialization. -

    This person will oversee Quality Control and Quality Assurance activities in support of externally sourced projects, internal testing, quality specification and documentation. The individual will act as interdepartmental liaison to various groups, including Analytical Development, Manufacturing Quality Assurance, and Regulatory Affairs.

    Responsibilities


    Improve quality management systems related to the product lifecycle from development to commercialization, overseeing activities related to QC testing, research and development Quality, and technology transfer.
    Perform product release activities and Contract Manufacturing Organization site management including Testing, Qualifications, Investigations, risk assessment and support onsite presence during manufacturing as needed.
    Oversee reagent quality control and stability program. Prepare, maintain, and review internal policies, procedures, systems, and processes, to ensure compliance to product requirements and international regulatory requirements and guidelines.
    Specifications and changes - Assists Product Development (PD) and Quality Assurance (QA) in documenting specifications, quality control testing requirements and support method qualifications to support new product design and development.
    Support internal and external audit follow-ups, issue tracking and closure. Compiles and maintains vendor documentation to support pivotal supplies (e.g. GLP and clinical trial supplies).
    Assist QA management in monitoring and driving key performance quality metrics. Ensure quality directives and policies are effective and implement action to ensure compliance.
    Assist QA Management on collection of data and preparing presentations, meeting minutes and report out on the management review and monthly updates for Quality function head.


    -




    Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic. Keywords: Compliance Manager, Location: Berlin, MA - 01503

Keywords: Yoh, A Day & Zimmermann Company, Worcester , Associate Director / Sr. Quality Compliance Manager -, Executive , Berlin, Massachusetts

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