uniQure

Director, Product Quality Management - Lexington, MA

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Active since 23-10-2017 Job category Quality / Health / Environment ...
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
The Position:

The Product Quality Leader with global responsibilities influences, develops, and enables organizations to drive and deliver a comprehensive product quality strategy to commercialize clinical stage products and develop a sustainable lifecycle management process.

The Product Quality Leader having a direct impact on product quality strategy and lifecycle management will provide Quality decisions and leadership to organizations that are responsible for establishing and maintaining life cycle management of end-to-end supply chain processes.

Responsible for Analytical Quality 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.

Represents Quality in CMC Team, Program Team, and business partner meetings to provide strategic direction and leadership to product development, registration, and approvals. In addition, this person interphases with Regulatory Affairs to author, review, and approve filings, and represents Quality in product related agency meetings.

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:

  • Facilitates and oversees the definition of product critical quality attributes, drives and delivers control strategies, delivers phase-appropriate process controls, identifies/oversees critical raw materials, labelling, shelf-life, and launch.
  • Provides direction and alignment across different CMC functions and influences both strategic and tactical Quality input to develop product quality strategies and life cycle management decisions for both clinical and commercial products in alignment with overall product strategies, and is accountable for decisions on product quality.
  • Enables alignment of product transition from clinical to commercial phase and tech transfers between sites as well as proposes product improvement activities in alignment with the overall product quality strategy.
  • 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.
  • Responsibilities include supporting and enabling appropriate Quality review of regulatory submissions, health authorities’ inter-phases (i.e. pre-filing meeting, filings, approval negotiations, post marketing commitments, annual reports, responses to questions, responses, and progress reports for regulatory commitments), and ensuring submissions are in line with the overall product strategy.
  • 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.
  • Ensures appropriate escalation to Senior Management of significant issues that may impact patient safety, product quality, supply, regulatory compliance or the uniQure brand.
  • 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.
  • Leads or represents Quality at various product quality related governance bodies.

Qualifications:

  • Ph.D. in Virology/Biochemistry/Biology, or relevant scientific/engineering discipline with at least 10 years’ experience; or MS with at least 15 years of industry experience in CMC and clinical developing and commercializing biologics
  • At least 10 years of organizational and cross functional team leadership successfully delivering business results
  • 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 of and experience with statistical analyses and the application of statistics
  • ~ 20% local and international travel maybe required

Core Competencies:

  • Advanced knowledge of global, especially US and EU GCP and GLP guidelines
  • Strong leadership in team management, decision making, change management, collaboration, delivering desired business results, and influence
  • 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 Pharmaceutical
Region United States
Keywords Quality

Contact information

Name Jennifer Wagner

Location

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