Sr Manager, Quality Assurance - Parenteral (Night Shift)

Role Summary

Sr Manager, Quality Assurance - Parenteral (Night Shift) responsible for leading the start-up and ongoing operation of the QA organization overseeing Parenteral operations at the Kenosha, WI site, with focus on formulation, filling, and visual inspection programs. Provides technical and administrative leadership, project management, and cross-functional collaboration to ensure quality systems compliance and readiness.

Responsibilities

• Lead the start-up and routine operation of the QA organization for Parenteral operations, providing technical and administrative leadership and project management.
• Serve as technical resource to review and approve technical documents.
• Collaborate with cross-functional teams to ensure equipment and systems meet quality requirements and are implemented with a Quality by Design framework.
• Support development of site quality culture and vision with emphasis on formulation, filling, and visual inspection programs.
• Assist in recruiting and building capability for a diverse quality assurance staff to support qualification, validation, and routine production.
• Manage a team of up to ~15 direct reports; promote a safe work environment and lead safety efforts.
• Develop the site operational readiness plan including quality processes and approval of procedures and controls.
• Foster a strong quality culture with open communication and teamwork; supervise and develop employees, ensuring a fair work environment.
• Review and approve GMP documentation (procedures, deviations, technical reports, change controls, etc.).
• Network with global and other parenteral sites to share best practices and knowledge.
• Collaborate cross-functionally with area process teams for metrics reviews, operational support, and deviation management.
• Support inspection readiness and interact with regulatory agencies during inspections regarding cGMP issues.
• Ensure data integrity by design.

Qualifications

• Required: Bachelor's degree in a science, engineering, pharmaceutical-related field or equivalent experience.
• Required: 5+ years in pharmaceutical leadership with QA experience, including cross-functional collaboration.
• Preferred: Certifications or demonstrated expertise in CSQA, CQE, or similar; track record in startup/scale-up environments; experience with highly automated filling and visual inspection equipment; experience with MES and electronic batch release; knowledge of Trackwise for deviation/change management.

Skills

• Quality Management Systems knowledge and regulatory requirements
• Excellent interpersonal, written and oral communication
• Technical aptitude with ability to train and mentor others
• Strong technical writing, problem-solving, and decision-making skills
• Experience with deviation and change management systems
• Ability to work in a highly automated pharmaceutical manufacturing environment

Education

• Bachelor's degree in science/engineering/pharmaceutical-related field or equivalent experience

Additional Requirements

• Ability to work 8-hour night shifts; overtime as required
• 10-25% travel, or relocation during project phase to support design and staffing
• May be required to respond to operational issues outside core hours