Associate Director - Quality Control Laboratories

Role Summary

The Associate Director - Quality Control leads all aspects of laboratory testing in support of manufacturing operations. This position requires the ability to multitask / prioritize, excellent written and oral communication skills, decision making ability, interpersonal skills, as well as the ability to anticipate problems then develop and implement alternative solutions.

Responsibilities

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Recruit / retain effective diverse staff; supervise, coach, and aid in development, performance management, ensure a fair and equitable work environment.
• Assist in the setting of human resource and business plan goals.
• Ability to lead and manage complex change agendas in a fast-paced environment, while delivering on multiple priorities.
• Apply knowledge of quality principles and GMPs toward the development of local procedures.
• Define and supervise quality plans for analytical projects to ensure accurate priority, resources, and direction have been provided.
• Interact effectively with customer and support groups.
• Define and maintain inspection readiness activities.
• Network with other areas to understand best practices, share knowledge, assist in tactical and strategic business planning, and to ensure customer needs are met.
• Influence development of improved and streamlined quality systems.
• Serve as conduit for corporate communications / initiatives.
• Serve as technical resource and review and approve technical documents.
• Facilitate assessment of assay variability contribution to total process variability and ensure lab initiatives are aimed at reducing measurement variability.
• Define, lead and/or support inspection readiness activities for lab operations and interact with Regulatory agencies during inspections.
• Network with other sites regarding new systems development.
• Work cross functionally at the site and global level to ensure recapitalization of equipment.
• Review and approve technical and GMP documents such as protocols, deviations, changes, summary reports, etc.
• Maintain open communications and promote teamwork and employee collaboration in the work group.

Qualifications

• Required: Bachelor of Science in Chemistry / Biology / Microbiology or related science.
• Required: 5+ years GMP laboratory experience.

• Preferred: Effective time management
• Preferred: Deep understanding of compliance requirements and regulatory expectations
• Preferred: Effective problem-solving and teamwork skills
• Preferred: Strong self-management and organizational skills

Education

• Bachelor of Science in Chemistry / Biology / Microbiology or related science

Additional Information

• Ability to work 8-hour days - Monday through Friday on site in Indianapolis, IN
• Ability to work overtime as required, including shutdowns
• Available off shift to respond to operational issues
• Minimal travel required