Supervisor, Quality Assurance - Systems

Catalent Pharma Solutions Inc   •  

Madison, WI

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 33 days ago

Position Summary

The Supervisor, Quality Assurance – Systems is responsible for assuring that all operations at Catalent meet or exceed cGMP regulations and customer requirements. The Supervisor, Quality Assurance – Systems assures the quality of operations through the management and enhancement of the document management and supplier quality assurance systems.

The Supervisor, Quality Assurance – Systems is accountable for the daily operations of the supplier quality assurance program, including release of incoming materials, management of non-conformances and qualification of suppliers to support the GMP manufacturing operations.

In concert with Catalent's Patient First philosophy, the Supervisor, Quality Assurance – Systems position safeguards all systems, processes and actions to ensure regulatory compliance is met, which is essential in providing high quality drug products for our clients and their patients.

The Role

  • Oversees the process of document control, including independently managing drafts, editing, approval, distribution and archiving, of all controlled documents.
  • Maintains staff by recruiting, hiring, and training employees; developing personnel growth opportunities, supporting employee motivation and providing strategic alignment with Quality Assurance Department and site initiatives.
  • Drives continuous improvement through leading cross function teams, to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements and KPI performance improvements.
  • Maintains data integrity and ensure compliance with company SOP's, specifications; as well as cGMP, ICH, FDA, EMA regulations or guidelines.
  • Maintains safe and healthy work environment by establishing and enforcing organization standards; adhering to legal regulations.

The Candidate

  • Master's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 12 years' related technical experience OR 6 years' related experience with demonstrated career progression including leadership responsibilities.
  • Bachelor's Degree in technical discipline (e.g. biology, biotechnology, engineering) or related life science with minimum of 14 years' related technical experience OR 8 years' related experience with demonstrated career progression including leadership responsibilities.

Catalent's standard leadership competencies that are used to interview and for Performance & Development

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Position Benefits

  • Fast tracked career growth, with annual performance review and feedback process
  • Competitive base salary with other compensation incentives including yearly incentive plan
  • Medical, Dental, Vision, and 401K are all offered on day one of employment
  • 19 days of Paid Time Off (PTO) + 7 paid holidays
  • Onsite gym, Catalent corporate discount perks, paid volunteer time off program and other benefits too numerous to mention!
  • Defined career path and annual performance review and feedback process.