AD, Quality Control

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

Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Associate Director, Quality Control provides leadership and technical direction by coordinating with others, the activities associated with the testing of viral and bacterial vaccines. This includes all steps of the manufacturing process according to the Regulations or requirements described in the Global Quality Guidance. This role is also responsible for developing a workforce that is quality focused that will maintain compliance and efficient QC processes.

Duties & Responsibilities

• Regularly monitors the testing capacities to support the production flows and ensures adequate resources to complete timely testing.
• May participate or facilitate problem solving when testing issues disrupt the production flow.
• Ensures Quality Control personnel have the proper skills which are demonstrated through defined qualification activities or studies by identifying core skills and tasks related to training requirements.
• Participates in the strategy development for new product transfers and equipment purchases in addition to long range planning for future equipment and facility needs.
• Participates in building budget for department expense and approve purchases.
• Ensures proper use of quality systems by monitoring deviation closure time, change controls, timely completion and thorough OOS investigations, good documentation practices, changes to facility documents, and overall compliance in the department.
• Participates in regulatory inspections and global/corporate audits, including management of the most appropriate action plan to address the findings pointed out by the investigators/auditors.

Requirements

• Masters in science related field or combination of a related undergraduate science degree and five to ten (5-10) years of relevant experience.
• Seven to ten (7-10) years of experience in biological manufacturing environment 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.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.