A-Line Staffing Solutions · 1 day ago
Director of Quality, 503B Pharmacy Operations
Dallas, TX, US
Full-time
Onsite
Director/Executive
8+ years expA-Line Staffing Solutions is seeking a Director of Quality for their 503B Pharmacy Operations, responsible for providing strategic and operational leadership for the Quality Unit within an FDA regulated environment. The role involves ensuring compliance with regulatory standards and overseeing quality systems in sterile compounding pharmacy operations.
Human ResourcesInformation Technology
Responsibilities
Serve as the primary technical and regulatory authority for sterile compounding and parenteral drug manufacturing within a 503B pharmacy environment
Ensure full compliance with FDA 503B guidance, USP 797, USP 800, USP 71, and applicable State Board of Pharmacy regulations
Act as the lead Quality representative during FDA inspections, state board inspections, and third party regulatory audits
Lead Quality Operations for sterile pharmacy manufacturing, including batch record review, release, and disposition of compounded sterile products
Oversee and continuously improve Quality Systems including deviations, CAPA, change control, complaints, OOS and OOT investigations, and recalls
Review and approve validation protocols, qualification reports, and SOPs to ensure alignment with cGMP, aseptic processing, and pharmacy standards
Maintain ongoing compliance with Wholesale Drug Distribution requirements
Partner cross functionally with Pharmacy Operations, Manufacturing, Engineering, and Supply Chain to support compliant facility design and workflows
Promote a strong culture of quality, compliance, and patient safety across pharmacy operations
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, Pharmacy, or a related discipline
Minimum of 8 years of experience in sterile compounding or aseptic processing within a pharmacy or pharmaceutical environment
Minimum of 5 years of leadership experience in a regulated 503B pharmacy or sterile manufacturing setting
Expert level, hands on knowledge of FDA 503B regulations and related guidance
Strong working knowledge of USP 797, USP 800, USP 71, and sterile pharmacy operations
Thorough understanding of 21 CFR Parts 210 and 211 and cGMP as applied to sterile drug manufacturing and compounding pharmacies
Proven success leading FDA inspections, State Board of Pharmacy inspections, and regulatory audits
Preferred
Advanced degree such as MS, PharmD, or MBA preferred
Company
A-Line Staffing Solutions
A-Line Staffing Solutions is a staffing and recruiting company specializing in pharmaceutical, medical, and IT staffing services.
501-1000 employees
H1B Sponsorship
A-Line Staffing Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (3)
2021 (4)
2020 (8)
Funding
Current Stage
Late StageCompany data provided by crunchbase