Associate Director - Quality Assurance - Device Assembly

Scorpion Therapeutics; Pleasant Prairie (WI); On-site; USD 110,000 - 150,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director for Quality Assurance to oversee device assembly operations at their Kenosha site. This role includes leading a QA team, developing operational readiness plans, and ensuring compliance with quality standards.

The ideal candidate should have at least 5 years of leadership experience in pharmaceutical QA and a bachelor's degree in a related field. Flex hours and limited travel are part of the offer.

Qualifications

• 5+ years pharmaceutical leadership with QA experience.
• 5+ years supporting pharmaceutical manufacturing.

Responsibilities

• Lead staffing, training, and oversight for Device Assembly operations.
• Support QA system implementation and execution.
• Develop quality processes and procedures.
• Ensure compliance with assembly procedures and controls.
• Manage inspection readiness and interact with Regulatory agencies.

Skills

Quality Management Systems

Regulatory knowledge

Communication

Technical writing

Education

Bachelor’s degree in science/engineering/pharma

Tools

SAP

MES

Veeva

Job description

Position Overview

Associate Director, Quality Assurance (QA) – Device Assembly (DA). Lead staffing, training, and QA oversight for start-up of combination product device assembly and operations at the Kenosha site (process development, operational readiness, qualification, and validation). Build site quality culture and lead the QA team for ongoing operation and inspection readiness.

Responsibilities

• Support Sr. Director, QA in site organization, Quality Management System implementation, and execution for Device Assembly and Packaging (DAP).
• Support safe work environment and lead safety efforts for the QA team.
• Develop operational readiness plan, quality processes, and approve DAP operational procedures.
• Build capable QA organization to ensure compliance with device assembly procedures and controls.
• Foster quality culture (open communications, teamwork, employee participation).
• Supervise/coach/mentor, performance manage, and support fair/equitable work environment.
• Manage priorities in fast-paced environment; demonstrate flexibility as issues change.
• Partner with production and design for 24/7 quality oversight.
• Support Operational Excellence and continuous improvement.
• Review/approve GMP documentation (qualification/validation protocols/reports, procedures, deviations, technical reports, change controls).
• Network with global/DA sites; work cross-functionally for metrics, operational support, issue/deviation management.
• Set HR and business plan goals; participate in business planning.
• Communicate project/production status.
• Lead inspection readiness and interact with Regulatory agencies.

Basic Requirements

• Bachelor’s degree in science/engineering/pharma or equivalent experience.
• 5+ years pharmaceutical leadership with QA experience (cross-functional).
• 5+ years supporting pharmaceutical manufacturing (preferably device assembly).
• On-site presence required.

Additional Skills/Preferences

• Quality Management Systems and regulatory knowledge; inspection readiness/execution.
• Facility/area start-up; equipment qualification and process validation.
• SAP/inventory systems; MES/electronic batch release.
• Automated combination products/packaging/warehouse; automated material movement.
• Deviation/change management systems (e.g., Veeva); strong communication and technical writing.

Additional Information

• Primary location: Kenosha, Wisconsin. Flex hours possible.
• Travel: ~10–20%.
• Short Term Assignment (6–9 months) at Device Assembly & Packaging site prior to role start.