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
Expertise in QC method development and qualification and
microbiological techniques. Knowledge of analytical techniques
associated with testing and release Biologics and reagents
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
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
Improve quality management systems related to the product lifecycle
from development to commercialization, overseeing activities
related to QC testing, research and development Quality, and
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: Boylston, MA - 01505