QA Director, API Manufacturing Startup

BioSpace; Lebanon (IN); On-site; USD 123,000 - 180,000; Full time

Job summary

Lilly is constructing an advanced manufacturing facility for API production in Lebanon, IN. The Associate Director – QA will partner with the Sr.

Director – QA to ensure robust quality oversight across operations, coach QA staff, and drive regulatory compliance during startup and ongoing GMP manufacturing. The role demands leadership in quality systems, deviations approvals, and cross-functional collaboration to meet internal and external commitments.

Qualifications

• BS or equivalent in a scientific field or engineering.
• 5+ years in CGMP Manufacturing.
• Knowledge of cGMPs.
• Experience supervising/leading people.
• Strong written and verbal communications skills.
• Strong attention to detail.
• Understanding of statistical tools and analysis.
• Ability to organize and prioritize multiple tasks.
• Ability to influence diverse groups.

Responsibilities

• Provide coaching/feedback to and develop QA employees.
• Utilize Human Resources tools to ensure right individuals are in the right job.
• Participate in organizational planning.
• Provide input into the business plan and ensure conformance to department budget.
• Exhibit cross-functional influence.
• Maintain and improve quality systems.
• Approve deviations, procedures, protocols, and change controls.
• Develop and maintain processes that support inspections and audits; prepare individuals to interact with auditors and inspectors.
• Participate in self-assessments and regulatory agency inspections.
• Ensure internal and external quality and supply commitments are met.
• Provide quality management oversight for API manufacturing, laboratories, and warehouses.
• Investigate complaints.
• Manage the creation, revision, and maintenance of cGMP documents.
• Provide oversight and review of changes to the Global Quality Standards and ensure local implementation of changes.
• Network with other sites regarding new or current quality systems.

Skills

CGMP Manufacturing

Leadership

Quality systems

Communications

Statistics

Computer skills

Attention to detail

Interpersonal skills

Task prioritization

Education

BS or equivalent in a scientific field or engineering

Job description

Lilly is constructing an advanced manufacturing facility for API production in Lebanon, IN. The Associate Director – QA will partner with the Sr.

Director – QA to ensure robust quality oversight across operations, coach QA staff, and drive regulatory compliance during startup and ongoing GMP manufacturing. The role demands leadership in quality systems, deviations approvals, and cross-functional collaboration to meet internal and external commitments.