Charlottesville, Virginia, United States · On-site
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 respons…
Skills: Sterile manufacturing, FDA regulations, EU GMP, Annex 1, Batch record review
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The Quality Assurance Manager oversees sterile manufacturing operations to ensure compliance with FDA, EU GMP, and Annex 1 standards. Key duties include managing batch record reviews, deviation investigations, CAPA implementation, and supporting regulatory audits.
Candidates must hold a bachelor's degree in biology or a related field and possess strong experience in lot release, deviation management, and CAPA systems. Proficiency in FDA regulations, EU GMP, and Annex 1 is required, along with excellent leadership and problem-solving skills.
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.
Your Sterile Injectable CDMO Partner
Afton Scientific is a Charlottesville, Virginia–based contract development and manufacturing organization (CDMO) specializing in sterile injectable pharmaceuticals. For over 20 years, the company has partnered with global pharmaceutical and biotech innovators to provide aseptic processing, small- and mid-batch vial filling, and advanced fill/finish services from clinical trials through commercial supply. Operating from FDA-inspected, cGMP facilities with isolator-based Grade A/Class 100 environments, Afton Scientific focuses on biologics, small molecules, and emerging modalities, including mRNA and other novel injectables. Its integrated capabilities span formulation support, sterile filling, packaging and labeling, plus in-house analytical and microbiology laboratories designed to streamline timelines and strengthen regulatory compliance. Guided by a commitment to quality, reliability, and innovation, Afton Scientific maintains a strong inspection record with U.S. and global health authorities and a robust Quality Management System built around continuous improvement. Backed by a multi-year growth roadmap and strategic investment, the company is expanding capacity with new pre-filled syringe and cartridge lines and an additional facility that will add hundreds of high-skill jobs while supporting the next generation of sterile injectable therapies.
Offices: 2020 Avon Ct, Charlottesville, VA 22902, US · 2030 Avon Ct, Charlottesville, Virginia 22902, US
Your Sterile Injectable CDMO Partner
Afton Scientific is a Charlottesville, Virginia–based contract development and manufacturing organization (CDMO) specializing in sterile injectable pharmaceuticals. For over 20 years, the company has partnered with global pharmaceutical and biotech innovators to provide aseptic processing, small- and mid-batch vial filling, and advanced fill/finish services from clinical trials through commercial supply. Operating from FDA-inspected, cGMP facilities with isolator-based Grade A/Class 100 environments, Afton Scientific focuses on biologics, small molecules, and emerging modalities, including mRNA and other novel injectables. Its integrated capabilities span formulation support, sterile filling, packaging and labeling, plus in-house analytical and microbiology laboratories designed to streamline timelines and strengthen regulatory compliance. Guided by a commitment to quality, reliability, and innovation, Afton Scientific maintains a strong inspection record with U.S. and global health authorities and a robust Quality Management System built around continuous improvement. Backed by a multi-year growth roadmap and strategic investment, the company is expanding capacity with new pre-filled syringe and cartridge lines and an additional facility that will add hundreds of high-skill jobs while supporting the next generation of sterile injectable therapies.
Offices: 2020 Avon Ct, Charlottesville, VA 22902, US · 2030 Avon Ct, Charlottesville, Virginia 22902, US
