Afton Scientific, LLC · 17 hours ago
Director of Quality Control
Charlottesville, VA
Full-time
Onsite
Director/Executive
8+ years expAfton Scientific, LLC is committed to advancing the quality and reliability of sterile pharmaceutical manufacturing. They are seeking a Quality Control Director to oversee all QC laboratory operations supporting sterile injectable pharmaceutical manufacturing, ensuring compliance with regulatory standards and leading a high-performing team.
BiotechnologyManufacturing
Hiring Manager
Alison Passino
Responsibilities
Lead and oversee all Quality Control operations, including:
Analytical and in‑process testing
Environmental monitoring and trending
Stability programs
Release testing and laboratory scheduling
Ensure QC operations meet or exceed cGMP, FDA, and regulatory expectations
Serve as the primary QC representative during regulatory inspections, audits, and client interactions
Own and drive QC‑related investigations, including OOS/OOT events, deviations, and CAPAs
Partner closely with Quality Assurance, Manufacturing, Technical Operations, and Engineering to support compliant, efficient production
Build, develop, and retain a high‑performing QC team, including managers, supervisors, and analysts
Establish clear ownership, accountability, and escalation pathways within the QC function
Ensure laboratories are properly staffed, trained, equipped, and validated to support current and future business needs
Drive continuous improvement initiatives while maintaining data integrity and compliance
Support implementation and optimization of laboratory systems and workflows as the organization scales
Qualification
Required
Minimum of eight (8) years of progressive experience in Quality Control within a GMP‑regulated pharmaceutical, biopharmaceutical, or CDMO environment
Minimum of four (4) years of experience leading QC teams and laboratory operations (Manager‑level leadership or above)
Minimum of four (4) years of hands‑on experience supporting FDA inspections, regulatory audits, and client audits
Strong working knowledge of: cGMP requirements applicable to QC laboratories
Strong working knowledge of: OOS/OOT investigations and CAPA processes
Strong working knowledge of: Data integrity principles (ALCOA+)
Preferred
Bachelor's degree in chemistry, Biology, Life Sciences, or a related scientific discipline
Experience in a CDMO or contract manufacturing environment
Prior experience with sterile or aseptic manufacturing and injectable products
Familiarity with LIMS and laboratory digital systems
Experience supporting tech transfers, scale‑up, or new product introductions
Advanced degree (master's or PhD) in a scientific discipline
Experience operating in a growth or transformation environment (scale‑up, expansion, new facility)
Company
Afton Scientific, LLC
Afton Scientific, a recognized leader in sterile injectable manufacturing and contract development and manufacturing organization (CDMO) services, distinguishes itself through unwavering commitment to quality, reliability, and transformative innovation.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2024-01-30Acquired
Leadership Team
Thomas Thorpe
CEO
Recent News
2024-04-26
2024-04-26
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