WorcesterRecruiter Since 2001
the smart solution for Worcester jobs

Associate Director / Sr. Quality Compliance Manager -

Company: Yoh, A Day & Zimmermann Company
Location: Bolton
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


    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.


    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.


    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: Bolton, MA - 01740

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Director, Network Solutions -Engineering
Description: Director, Network Solutions -Engineering Plymouth, MN, US, 55441 83862 About CDK Global, Inc CDK Global NASDAW:CDK is a leading provider of integrated data and technology solutions to the automative, (more...)
Location: Plymouth
Posted on: 03/7/2021

Branch Manager
Description: Start A Great Career With A Great Purpose - We are a group of industry experts with the experience and drive to turn any financial need into a reality. Our mission is to satisfy the financial needs of (more...)
Company: Mariner Finance
Location: Milford
Posted on: 03/7/2021

Nursing - Registered Nurse - Manager
Description: Loyal Source is actively seeking a motivated Registered Nurse - Manager for a contract assignment in Attleboro, MA. br br Requirements: br br br Active Registered Nurse - Manager license br (more...)
Company: Loyal Source
Location: Attleboro
Posted on: 03/7/2021

Sales and Operations Management Trainee
Description: br br Position Summary: br Take charge. Think fast. Move forward. As a Sales and Operations Management Trainee in our fast-paced environment, you will use your hard-earned degree to run a business (more...)
Company: Penske
Location: Chicopee
Posted on: 03/7/2021

General Manager
Description: Marco Pierre White Steakhouse Bar Grill General Manager Competitive Salary and Benefits Crowne Plaza Plymouth, Plymouth PL1 2HJ We're a global hospitality management company who partner with internationally (more...)
Company: Thistle City Barbican
Location: Plymouth
Posted on: 03/7/2021

Preconstruction Manager
Description: Interested in an outstanding opportunity to become part of a team with a stellar reputation as a community engaged Employer of Choice Consigli Construction Co., Inc. Consigli is a fourth generation, (more...)
Company: Consigli Construction Co., Inc.
Location: Milford
Posted on: 03/7/2021

Regional Director (BCBA) - Chicopee, MA
Description: Beacon ABA Services, Inc. is a private group practice of behavior analysts and behavioral therapists organized to provide intensive behavioral services to individuals with developmental disabilities. (more...)
Company: Human Services Management Corporation
Location: Chicopee
Posted on: 03/7/2021

Procurement Manager
Description: Full-time Company Description Founded by Eric Lecoq in 1991, we are the preeminent manufacturer of fine French pastries in the US.Intense focus on innovation, investment in state-of-the-art equipment, (more...)
Company: Lecoq Cuisine Corp
Location: Stratford
Posted on: 03/7/2021

Area VP, Merchandising & Marketing - Plymouth, MN
Description: Company: Packaged Goods / Food / Beverage, Plymouth, MN Remarks: Fosters the development, implementation and successful execution of innovative category and Go to Market GTM strategies. Maintains (more...)
Company: Cavendish Farms Corporation
Location: Plymouth
Posted on: 03/7/2021

Associate Director EOC-NTP-21-1
Description: NOTICE OF VACANT POSITION-Applications are being accepted for the following vacancy on the Non-teaching Professional staff at the Capital District Educational Opportunity Center, which provides vocational (more...)
Company: Hudson Valley Community College
Location: Troy
Posted on: 03/7/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Worcester RSS job feeds