Associate Director, Quality Control - Vaccines

Jobs2Web; Gainesville (GA); On-site; USD 150,000 - 230,000; Full time

Job summary

Boeehringer Ingelheim in the United States, Georgia, Gainesville seeks an Associate Director, Quality Control to lead testing of viral and bacterial vaccines, ensuring compliance with global quality guidance and efficient QC processes.

You will coordinate with manufacturing, regulatory, and QA teams to build a capable workforce and contribute to long-range planning, budgeting, and regulatory inspections.

Qualifications

• Master's degree in science or related undergraduate with 5–10 years of relevant experience.
• 7–10 years in biological manufacturing with focus in Quality or Analytical Research and Development.
• Thorough knowledge of 9 CFR.
• Demonstrated technical knowledge.
• Experience working with federal regulatory agencies.
• Proven leadership skills.
• Knowledge of EU GMP preferred.

Responsibilities

• Regularly monitors testing capacities to support production flows and ensures adequate resources to complete testing.
• May participate or facilitate problem solving when testing issues disrupt production flow.
• Ensures QC personnel have proper skills demonstrated through qualification activities or studies by identifying core skills and training requirements.
• Participates in strategy development for new product transfers and equipment purchases, and long-range planning for future needs.
• Participates in building budget for department expenses and approves purchases.
• Ensures proper use of quality systems by monitoring deviation closure time, change controls, and timely investigation closures; maintains good documentation practices.
• Participates in regulatory inspections and global/corporate audits, including action plans to address findings.

Skills

Leadership

Technical knowledge

Regulatory knowledge

Education

Master's degree in science related field

Job description

Boeehringer Ingelheim in the United States, Georgia, Gainesville seeks an Associate Director, Quality Control to lead testing of viral and bacterial vaccines, ensuring compliance with global quality guidance and efficient QC processes.

You will coordinate with manufacturing, regulatory, and QA teams to build a capable workforce and contribute to long-range planning, budgeting, and regulatory inspections.