Vice President, Quality and Regulatory

Company: Grand River Aseptic Manufacturing, Inc.
Location: Grand Rapids
Posted on: March 21, 2023

Job Description:

Quality, Service, Collaboration, Courage. Do you exhibit these values and wish to be around others that do too? Are you interested in making a difference in your community and the world? Are you looking for a place where you can grow and learn in a diverse, community-minded culture? If these statements resonate with you, Grand River Aseptic Manufacturing (GRAM) welcomes you to apply to join our community of dedicated individuals improving lives every day.Overview of this position:Provide direction and leadership to the Grand River Aseptic Manufacturing (GRAM) quality organization. Define, implement and oversee GRAM's quality management system. This position is responsible for communicating and implementing strategic objectives, maintaining budgetary responsibility and control, and providing accountability and ownership to ensure patient safety, improve quality outcomes, increase productivity and achieve consistent performance.Non-Negotiable Requirements:

• Bachelor's degree in Life Sciences or a related field, and/or 15-20 years progressive leadership experience within a pharma, biopharma and/or biotech manufacturing environment.
• Direct experience interacting with FDA and other regulatory authorities.
• Knowledge of Quality principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
• Experience and expertise in aseptic manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines and multinational regulatory standards is required.
• Strategic analytical thinker with strong business acumen.
• Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
• Demonstrated team leadership capabilities with a proven track record of meeting objectives.Preferred Requirements:
  • Master's degree in Life Sciences or a related field, and/or 15-20 years progressive leadership experience within a pharma, biopharma and/or biotech manufacturing environment.
  • Prior experience working in a fast-paced, emerging growth CMO is preferred.Responsibilities Include (but are not limited to):
    • Provide leadership and oversight to the Quality Assurance, Quality Systems and Compliance, Laboratory Services, Continuous Improvement, and Regulatory Affairs teams, including hiring, managing, motivating, coaching and mentoring.
    • Provide leadership and oversight to the Quality Assurance, Quality Systems and Compliance, Laboratory Services, Continuous Improvement, and Regulatory Affairs teams, including hiring, managing, motivating, coaching and mentoring.
    • Define and oversee implementation and maintenance of the GRAM Quality Management System.
    • Participate as a core member of the GRAM Operations Leadership Team, which is responsible for operational oversight of all GRAM's operations.
    • Participate as a core member of the Executive Team, providing strategic guidance related to quality within the overall organization.
    • Provide reports on the quality organization to GRAM's Board of Directors and/or ownership.
    • Develop corporate quality objectives and link them to meaningful and measurable quality metrics which are aligned with corporate objectives.
    • Assess, define and allocate Quality resources as required to support the effective implementation of the QMS and oversight of cGMP operations.
    • Collaborate with GRAM's clients to determine regulatory strategies for new product introduction, technical transfer, and change management.
    • Review client regulatory documents to ensure alignment with GRAM strategic regulatory direction.
    • Ensure that all regulatory compliance documents are prepared in accordance with regulatory guidelines, internal standards and SOPs.
    • Ensure the proper management, retention and version control of all applicable regulatory compliance documentation.
    • Oversee QA/QC/RA discussions during technical meetings with all customers and regulatory inspectors.
    • Identify opportunities / risks and propose methods to improve quality of customer product, service being administered, department operations and/or costs.Full job description available during formal interview process.

Keywords: Grand River Aseptic Manufacturing, Inc., Grand Rapids , Vice President, Quality and Regulatory, Executive , Grand Rapids, Michigan