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Senior Manager, Process and Procedures Quality

Basking Ridge, NJ 07920

Posted: 03/14/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 551946 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 60-90/hr **salary will be commensurate with experience 

Job Summary:

We are looking for a Process & Procedures (P&P) Senior Quality Manager who is responsible for performing quality review of procedural documentation and providing oversight of the portfolio to ensure compliance with REGN standards and industry best practices. The senior Quality Manager will identify and advise leadership of trends from quality reviews.

A typical day may include:
  • Manages and performs quality review of procedural documentation to ensure deliverables adhere to standards, identify and evaluate issues and/or gaps in procedural document content; in collaboration with P&P Ops Mgr. and Author, propose effective solutions
  • Manage and support procedural document gap and impact assessment
  • Provides oversight and mentorship to Quality Managers and Document Coordinators as needed
  • Track periodic review due dates to ensure 100% compliance rate for periodic reviews as needed
  • Develop and evaluate metrics to identify trends and provide recommendations for continuous improvements to further strengthen procedural document development
  • P&P Quality Lead for inspection management activities with team lead as needed
  • Review and provide guidance to procedural documents as they pertain to Regulatory requirements, Industry standard processes and business needs
  • Negotiates sophisticated situations without direct authority
  • Tracks and develops effectiveness reports based on internal requirements
  • May require up to 25% travel

      Role may be for you if:
  • Strong knowledge of GCP, GVP and regulatory requirements
  • Demonstrated proficiency in project management, collaboration and negotiation of sophisticated situations
  • Self-motivated with the ability to work effectively in a dynamic environment
  • Uses critical thinking and situational analysis to solve problems and prioritize with varying levels of urgency
  • Detailed-oriented with ability to apply details to project/department goals/strategy
  • Demonstrated experience developing and managing procedural documents/SOPs
  • Six-Sigma knowledge is a plus
  • To be considered for this opportunity you have a BS/BA Degree with 7 years relevant experience or MS degree and 3+ years relevant experience.
  • A minimum of 3-5years’ experience in a Quality role and experience in controlled procedural document principles, process design and styles, and leading process improvements
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