Quality Assurance Manager

Initial Therapeutics, Inc.; Virginia (MN); On-site; USD 120,000 - 160,000; Full time

Job summary

Afton Scientific is seeking a Quality Assurance Manager to lead quality oversight of sterile manufacturing at its Charlottesville, Virginia site. You will ensure compliance with FDA regulations, EU GMP, and Annex 1, perform batch record reviews, and drive CAPA and deviation investigations to uphold sterility and data integrity.

You will collaborate with manufacturing, quality control, and regulatory affairs to maintain audit readiness and continuous improvement in a fast‑paced environment.

Qualifications

• Bachelor's degree in biology or related field required.
• Strong knowledge of FDA regulations, EU GMP, and Annex 1.
• Experience with lot release, deviation management, and CAPA systems.
• Experience supporting regulatory inspections and audits (FDA/Client).
• Excellent problem-solving, communication, and leadership skills.

Responsibilities

• Ensure operations comply with FDA regulations, EU GMP and Annex 1 for sterile and non-sterile manufacturing.
• Review batch records and supporting documentation per approved procedures to ensure quality & data integrity.
• Lead and support deviation investigations with root cause analysis and timely resolutions.
• Develop, implement, and track CAPAs aligned with quality system requirements.
• Review and approve SOPs, protocols, and validation documentation for sterilization, aseptic filling, cleaning, and gowning.
• Ensure personnel qualification and training for aseptic operations, including media fills and gowning qualifications.
• Support audits and regulatory inspections; act as SME for sterile manufacturing and Annex 1 compliance.
• Partner with Manufacturing, Quality Control, and Regulatory Affairs to align quality standards and regulatory commitments.
• Monitor quality metrics and drive continuous improvement initiatives.
• Provide guidance and training to QA personnel and cross-functional teams on quality systems and compliance.

Skills

FDA regulations

EU GMP

Annex 1

Lot release

Deviation management

CAPA

Regulatory inspections

Leadership

Communication

Education

Bachelor's degree in biology or related field

Tools

eQMS

ICH Q9

Job description

At Afton Scientific, every role contributes to advancing the quality, reliability, and strategic impact of our sterile pharmaceutical manufacturing services. Our team is driven by innovation, collaboration, and long‑term partnerships that shape the future of healthcare. We support employees at every stage of their career by fostering an environment where development, learning, and meaningful impact are possible.

We invite you to explore opportunities to join our organization and contribute to our mission. We are currently seeking Quality Assurance Manager to support our expanding commercial footprint at our on‑site facility in Charlottesville, Virginia.

Overview of this Position

The Quality Assurance Manager leads quality oversight for sterile manufacturing operations, ensuring full compliance with FDA regulations, EU GMP, and Annex 1 requirements. This role is responsible for batch record review and lot release, as well as driving robust deviation investigations and CAPA management to maintain product sterility assurance and regulatory compliance. The QA Manager partners closely with manufacturing, quality control, and engineering teams to support efficient production while upholding the highest standards of aseptic processing and contamination control in a dynamic, growth-oriented environment.

Non‑Negotiable Requirements

• Bachelor’s degree in biology or related field
• Strong working knowledge of FDA regulations, EU GMP, and Annex 1
• Proven working experience in lot release, deviation management, and CAPA systems
• Experience supporting regulatory inspections and audits (FDA/Client)
• Excellent problem-solving, communication, and leadership skills.

Preferred Requirements

• Experience with electronic quality management systems (eQMS).
• Strong understanding of risk management principles (e.g., ICH Q9).
• Ability to manage multiple priorities in a fast‑paced environment.

Responsibilities Include

• Ensure operations are conducted in accordance with applicable FDA regulations, EU GMP requirements, and Annex 1 guidance for both sterile and non‑sterile manufacturing activities
• Review batch records and supporting documentation in accordance with approved procedures to ensure product quality and data integrity prior to disposition
• Lead and support deviation investigations, including documentation of root cause analysis and implementation of timely, compliant resolutions
• Develop, implement, and track Corrective and Preventive Actions (CAPAs) in alignment with quality system requirements to mitigate recurrence of identified issues
• Review and approve SOPs, protocols, and validation documentation related to sterilization processes, aseptic filling, cleaning, and gowning practices
• Ensure personnel qualification and training requirements for aseptic operations— including media fills and gowning qualifications—are maintained, current, and effective
• Support internal and external audits, including regulatory inspections, and maintain a state of audit readiness; serve as a subject matter expert for sterile manufacturing and Annex 1 compliance when required
• Partner with Manufacturing, Quality Control, and Regulatory Affairs to ensure alignment on quality standards, expectations, and regulatory commitments
• Monitor quality metrics and performance indicators to identify trends and support continuous improvement initiatives
• Provide guidance and training to QA personnel and cross‑functional teams on quality systems, compliance expectations, and best practices; support departmental operations and staff development

The duties listed above are intended to describe the essential functions of this position. Additional responsibilities may be assigned as needed. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this job. This role may require sitting, standing, or walking for extended periods, using a computer, and working in a standard office environment. Specific physical or environmental requirements will be addressed through the reasonable accommodation process. We do not discriminate based on disability and will provide reasonable accommodation as required by law.