Sterile QA Operations Leader — GMP & Compliance

Civica Rx; Petersburg (VA); On-site; USD 110,000 - 150,000; Full time

Job summary

Civica Rx in Petersburg, Virginia is seeking a Quality Assurance Supervisor-Operations to lead quality systems for sterile fill-finish manufacturing and ensure CGMP compliance. The role ensures ongoing FDA readiness and establishes robust documentation practices across manufacturing and support functions.

You will oversee validation, batch records, change control, and training; partner with cross-functional teams to maintain product quality, safety, and regulatory readiness, with limited travel.

Qualifications

• Bachelor's degree in a scientific discipline with 5+ years of Quality/CGMP experience in the pharmaceutical industry.
• Experience in sterile injectable manufacturing and packaging operations is required.
• Proven project management, organization and execution skills for shop floor manufacturing.
• Experience supporting regulatory inspections is required.
• Excellent interpersonal and written communication skills with experience using various software/electronic applications.

Responsibilities

• Establish and maintain quality systems for manufacturing operations to enable reliable supply of quality generic medications to patients.
• Promote a quality mindset and safety for all operational activities.
• Oversee sterile fill-finish manufacturing quality aspects including aseptic simulations, batch records, and shop-floor quality.
• Ensure compliance with Civica, FDA and DEA regulatory requirements.
• Establish and maintain SOPs and training for QA shop-floor support.
• Provide leadership and training to ensure staff are qualified and competent.
• Support equipment qualifications and product/process transfers and validation.
• Participate in quality risk analysis and implement corrective actions.
• Travel is limited but may occasionally be required.

Skills

Project management

Organization

Quality assurance

Interpersonal skills

Written communication

Autonomy

CGMP experience

Leadership

Regulatory inspections

Adaptability

Education

Bachelor's degree in a scientific discipline

Job description

Civica Rx in Petersburg, Virginia is seeking a Quality Assurance Supervisor-Operations to lead quality systems for sterile fill-finish manufacturing and ensure CGMP compliance. The role ensures ongoing FDA readiness and establishes robust documentation practices across manufacturing and support functions.

You will oversee validation, batch records, change control, and training; partner with cross-functional teams to maintain product quality, safety, and regulatory readiness, with limited travel.