Quality Systems Project Manager

Flexible: Grand Haven, Michigan, Lewes, Delaware or Wilmington, Delaware

Position Summary

This role is responsible for management of Global Quality Systems related projects and associated compliance to regulatory and customer requirements.  Identify areas for improvement, obstacles to improvements, and implement changes to meet site quality needs.  Perform all duties in a manner consistent with site and Corporate policies,  cGMP, safety, environmental and human resources policies and procedures

Reports to the Director, Corporate Quality and Regulatory.

Essential Duties and Responsibilities

  • As assigned by Quality Corporate Management, oversee and manage Quality System project activities related to quality deliverables at the Corporate and site level. These projects include, but are not limted to process and cleaning validation, analytical or microbial method validation, critical instrument, equipment and facility qualifications, tech transfer activities of process and methods internal and external to SPI.
  • To support project activities (as applicable), the Quality Systems Project Manager is expected to define project tasks, develop project plans and timelines, coordinate the project team and provide direction and support.
  • Provide accurate and timely updates of project activities to senior management. Work with cross functional teams to drive improvements to business performance with adherence to quality and compliance requirements.
  • Recommend and assist with implementation of suggestions and changes to improve the quality of products, plants, and the overall quality system. Develop creative solutions to problems. These project may include but are not limited to system harmonization at the site and corporate level.
  • Communicate activities and issues to the Global Head of Quality and Regulatory in a regular and timely manner. Obtain buy-in from the Site Quality Heads and Global Quality Head for direction and decisions with potential impact to the facility, products and other departments

Leadership Traits

  • Honesty, integrity, and the ability to work collaboratively, respectfully and safely
  • A strong contributor with the ability to effectively manage up, down, and across the organization
  • Drives accountability within the organization
  • Leads by example and actively engages appropriate personnel to make informed decisive decisions
  • Effective clear and concise communication
  • Ability to work and lead in a diverse, global organization

Supervisory Responsibilities

This position will have no direct reports.

Education and/or experience

  • Minimum of a Bachelor’s Degree in an applicable science field.
  • 10-15 years of relevant experience in a Pharmaceutical GMP setting.
  • Knowledge of analytical chemistry, general lab instrument and equipment general understanding of process chemistry requirements and overall Pharmacueitcal Quality Systems.
  • Understanding of Computer System Validation
  • Technical Project Management experience.
  • Good working knowledge of cGMP, USP/EP, ICH and FDA guidelines is necessary.

Travel Requirements

Working location is flexible. It will be located at one of our three US locations:

  • Lewes, Delaware
  • Wilmington, Delaware
  • Grand Haven, Michigan