Night-Shift Senior QA Manager, Parenteral Manufacturing

Regulatory Jobs

Pleasant Prairie (WI)

In loco

USD 98.000 - 143.000

Tempo pieno

6 giorni fa
Candidati tra i primi
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Descrizione del lavoro

Lilly is seeking a Sr. Manager, Quality Assurance (Parenteral) for its Kenosha, Wisconsin site. The role leads the QA team, drives GMP compliance, and supports startup, validation, and routine production across filling, dispensing, and inspection operations.

The position emphasizes leadership, quality culture, regulatory readiness, and collaboration with global teams to ensure data integrity and compliant processes.

Competenze

  • Bachelor's degree in science, engineering, or related field.
  • 5+ years in pharmaceutical leadership with cross-functional experience.
  • Excellent interpersonal, written and oral communication skills.
  • Strong technical aptitude; ability to train and mentor others.
  • Willingness to travel 10–25% and work overtime as required.

Mansioni

  • Lead the QA organization for parenteral operations at Lilly's Kenosha site, providing technical and administrative leadership.
  • Review and approve GMP documents and deviations.
  • Collaborate with cross-functional teams to ensure quality by design and compliant equipment/systems.
  • Support development of site quality vision, strategy, and culture.
  • Assist in recruiting and developing diverse QA leadership; manage 8–12 direct reports.
  • Oversee safety programs and site readiness for inspections; support regulatory interactions.

Conoscenze

Interpersonal skills
Written and oral communication
Technical aptitude
Mentoring
Travel willingness
Overtime flexibility

Formazione

Bachelor's degree in science/engineering
ASQ CSQA Certification

Strumenti

Trackwise
MasterControl
Veeva

Descrizione del lavoro

Lilly is seeking a Sr. Manager, Quality Assurance (Parenteral) for its Kenosha, Wisconsin site. The role leads the QA team, drives GMP compliance, and supports startup, validation, and routine production across filling, dispensing, and inspection operations.

The position emphasizes leadership, quality culture, regulatory readiness, and collaboration with global teams to ensure data integrity and compliant processes.

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