Sr. QA Specialist, Product Quality Management - Lexington

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Active since 23-05-2018 Job category Quality / Health / Environment ...
Location Lexington Level Mid-Senior level
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
The Position:

The Product Quality Management Specialist is responsible for analytical life cycle management including method validation and life cycle management of methods, critical reagents and reference standard program management, stability program management, process controls and specifications management, and development study management.

Enables continuous improvement to have a strategic product profile, robust process, facilities, methods, labelling, shelf life, and continuous supply.

A summary of the major responsibilities:

  • Ensures implementation, maintenance, and improvement of method validation and life cycle management of QC methods including compendia methods, reference standard and critical reagents management, stability program management, in-process controls and products specification management, development study management, QC’s end-to-end operations and continuous improvement strategies, and QC inspectional readiness program.
  • Develop and implement strategy, policies, and procedures to maintain method, Stability and specification life cycle management
  • In collaboration with operations, provides both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations.
  • Responsibilities include supporting stability program for multiple drug products, drug substances, intermediates, cell banks, and reference standards.
  • Develop and implement strategy, policies, and procedures to maintain Critical Raw Materials, Ref. Std. and Critical Reagents life cycle management
  • Identify, qualify, re-qualify, and stability of addental Clinical Ref. Std. and Commercial Ref. Std.
  • Responsible for opening and implementing clinical, PVR, and commercial specification (product, cell bank, and virus seed bank) through Change Control
  • Represent Quality Assurance to guide various special projects and technical meetings, such as with the Method Technical Transfer project, as needed
  • Owner and author of specifications (product, cell bank, and virus seed bank), associated part numbers, and related exceptions
  • Supports and enables escalation and/or strategic management of Quality Risk Management (QRM) associated with end-to-end supply chain, health authorities’ directions/decisions, market intelligence, and other geo-political matters.
  • Ensures appropriate escalation to Senior Management of significant issues that may impact patient safety, product quality, supply, regulatory compliance or the uniQure brand.



  • MS in Virology/Biochemistry/Biology, or relevant scientific/engineering discipline with at least 8 years’ experience in CMC and clinical developing and commercializing biologics
  • Strong scientific and global cGMP compliance expertise to ensure robust analysis of complex data to recommend and/or make risk based Quality decisions in biopharmaceutical product life cycle management
  • Demonstrated knowledge and execution of global regulations, quality systems, and processes in biopharmaceutical end-to-end supply chain
  • Knowledge and experience in laboratory analyses, method development and laboratory controls.
  • Knowledge of and experience with statistical analyses and the application of statistics


Core Competencies:

  • Advanced knowledge of global, especially US and EU GCP and GLP guidelines
  • Confident, independent, self-starter, proactive, and results-oriented with high performance standards
  • Strong ability to prioritize and operate with a sense of urgency
  • Solid organizational, analytical and problem-solving skills
  • Effective communication skills with the ability to interact with all levels of the key stakeholder with demonstrated interpersonal skills
  • Demonstrated ability to effectively solve problems and implement practical solutions in a dynamic and innovative environment
  • Strong operational and business acumen
  • Exhibits highest integrity and committed to ethics and compliance standards
  • Strong emotional intelligence
More information
This listing is a full-time job

Job category Quality / Health / Environment / Safety
Industry / Industries Biotechnology
Region United States
Keywords Quality

Contact information

Name Jennifer Wagner