Manager, Quality Engineering (357)

Civica Rx; Petersburg (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in pharmaceutical manufacturing seeks a Manager of Quality Engineering to lead compliance and quality systems at their Petersburg, Virginia site. The role involves overseeing quality assurance processes, managing a team, and ensuring adherence to regulatory standards. Ideal candidates will have significant experience in CGMP management and a strong background in quality systems.

Qualifications

• At least 8 years of Quality/CGMP management experience in pharma.
• Knowledge of 21CFR Part 11, data integrity, and electronic records.

Responsibilities

• Establish and maintain quality system processes related to GMP compliance.
• Oversee validation and qualification activities, ensuring compliance.
• Lead and support the Quality Assurance Engineering team.

Skills

Project Management

Communication

Education

Bachelor’s degree in a scientific discipline

Job description

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About Civica

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all-time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. The causes include "race to the bottom" pricing, manufacturing challenges, and predatory pricing.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce drug shortages and high prices. It has expanded its mission to include lowering medication costs at the pharmacy counter and developing affordable biosimilar insulin.

Job Description

The Quality Assurance-Engineering Manager will join Civica at the Petersburg, Virginia site, leading quality systems and compliance to ensure the facility meets cGMP and FDA standards, supporting successful approval and ongoing operations.

Responsibilities

• Establish and maintain quality system processes related to GMP compliance.
• Oversee validation and qualification activities, ensuring compliance and proper documentation.
• Lead and support the Quality Assurance Engineering team, ensuring qualification, competence, motivation, and safety.
• Stay informed on regulatory requirements and provide technical support.
• Support product and process transfers, validation, change control, CAPA, deviations, investigations, and other quality processes.
• Manage calibration and maintenance programs, quality risk management, validation support, and promote a quality and safety mindset.
• Develop and deliver personnel qualification and training procedures.
• Travel up to 10% as needed.

Qualifications

• Bachelor’s degree in a scientific discipline and at least 8 years of Quality/CGMP management experience in pharma.
• Knowledge of 21CFR Part 11, data integrity, and electronic records.
• Strong project management and communication skills.
• Experience with regulatory inspections and lifecycle quality management.
• Self-motivated, flexible, and capable of working independently or within guidelines.

Preferred Qualifications

• Expertise in sterile pharmaceutical isolator technology, combination products, or medical devices.
• Experience in process, method, and cleaning validation.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industry: Pharmaceutical Manufacturing