QA Manager-Night Shift

About the role

The Night Shift Manager, Quality Assurance (QA) - Device Assembly and Packaging (DAP), will initially serve as the QA representative supporting the Device Assembly and Packaging workstream overseeing commissioning and qualification at Lilly's new Concord, North Carolina site. This role is responsible for QA technical oversight including document approvals (e.g., Commissioning and Qualification Packages, procedures) and cross-functional decision making.

Responsibilities

• Support the start-up and routine operation of the QA organization overseeing the Device Assembly and Packaging operations at Lilly's Concord, North Carolina pharmaceutical manufacturing site.
• Support initial recruiting, build capability, for a diverse leadership and quality assurance staff to support qualification, validation and routine production.
• Manage a team of up to approximately 14 direct reports.
• Support the site to ensure a safe work environment including supporting and leading safety efforts for your team.
• Develop the quality on the floor programs to support GMP manufacturing.
• Assist with developing the training program for floor support and training QA personnel.
• Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment.
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Network with global and other device assembly sites to understand best practices and share knowledge.
• Work cross-functionally with the area process teams for metrics reviews, operational support, and issue/deviation management.
• Support inspection readiness activities. Interact with regulatory agencies during inspections regarding cGMP issues.
• Ensure data integrity by design.

Requirements

• Bachelor's degree in a science, engineering, pharmaceutical-related field of study or equivalent experience.
• 5+ years in pharmaceutical leadership with specific QA experience, including leading or working effectively with a cross-functional group.

Qualifications

• Authorized to work in the United States on a full-time basis.

Skills & Preferences

• Commit to successfully maintaining Lilly Computer System Quality Assurance (CSQA) Certification.
• Strong knowledge of Quality Management Systems and applicable regulatory requirements.
• Excellent interpersonal, written and oral communication skills.
• Strong technical aptitude and ability to train and mentor others.
• Demonstrated technical writing skills.
• Demonstrated problem-solving and decision-making skills.
• Previous experience directly supporting a pharmaceutical manufacturing operation.
• Previous facility or area start up experience.
• Previous equipment qualification and process validation experience.
• Previous experience with highly automated combination products and packaging equipment.
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• CQM, CQE, or CQA certification from the American Society for Quality (ASQ).
• Previous experience with deviation and change management systems including Trackwise.