Quality Director â Sterile Manufacturing
A-Line Staffing Solutions, Dallas, Texas, United States, 75215
Director of Quality – Sterile Manufacturing (503B / Aseptic Processing)
Dallas, TX 75226 (Onsite – Monday–Friday) Full-Time | Direct Hire
If interested, please email your resume to LKOPASZ@ALINESTAFFING.com or 5867107959
A growing, FDA-regulated pharmaceutical manufacturing organization is seeking an experienced Director of Quality to lead the Quality Unit for its 503B Outsourcing Facility. This is a critical leadership role responsible for regulatory compliance, sterile drug manufacturing oversight, and quality systems governance within a high-visibility operation.
This position serves as the primary Subject Matter Expert (SME) for all regulatory and compliance matters related to 503B outsourcing facilities, USP
, USP
, and aseptic processing.
Sterile Manufacturing (503B / Aseptic Processing) Position Summary
The Director of Quality provides both strategic direction and hands-on leadership for sterile drug quality operations. This role oversees quality systems, batch release, compliance programs, and inspection readiness while ensuring adherence to FDA guidance, cGMP standards, and USP regulations.
Sterile Manufacturing (503B / Aseptic Processing) Key Responsibilities
Regulatory & Compliance Leadership
Serve as the technical authority for aseptic manufacturing within a 503B Outsourcing Facility Ensure full compliance with FDA 503B guidance, USP
, USP
, and cGMP (21 CFR 210/211) Maintain compliance with Wholesale Drug Distribution requirements Interpret and apply evolving regulatory guidance to quality systems and operations
Inspection & Audit Representation
Act as Lead Management Representative during FDA inspections, state board audits, and third-party assessments Lead inspection readiness and regulatory response strategies
Quality Operations Oversight
Direct Quality Operations for sterile drug manufacturing Oversee batch record review, product release, and disposition for compounded sterile preparations (CSPs) Ensure procedures support aseptic processing and sterile manufacturing standards
Quality Systems Management
Manage deviations, CAPA, change control, complaints, recalls, OOS/OOT investigations Approve and oversee validation protocols, qualification reports, and SOPs with a 503B compliance focus
Risk & Continuous Improvement
Drive a proactive, risk-based quality culture Ensure facility and process designs align with regulatory expectations
Sterile Manufacturing (503B / Aseptic Processing) Required Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field
Advanced degree (M.S., Pharm.D., MBA) preferred
8+ years of experience in aseptic processing of sterile drugs 5+ years in a quality leadership role Expert knowledge of:
FDA Section 503B requirements and guidance USP
, USP
, USP
Sterility Testing 21 CFR Parts 210/211 (cGMP) State Board of Pharmacy regulations for outsourcing facilities
Proven success leading FDA inspections and regulatory audits
Sterile Manufacturing (503B / Aseptic Processing) Key Competencies
Deep subject matter expertise in 503B quality systems Advanced knowledge of parenteral sterile drug manufacturing Strong leadership with hands-on execution capability Excellent risk management and regulatory decision-making skills Ability to thrive in a fast-paced, high-accountability environment
If interested, please email your resume to LKOPASZ@ALINESTAFFING.com or 5867107959
Dallas, TX 75226 (Onsite – Monday–Friday) Full-Time | Direct Hire
If interested, please email your resume to LKOPASZ@ALINESTAFFING.com or 5867107959
A growing, FDA-regulated pharmaceutical manufacturing organization is seeking an experienced Director of Quality to lead the Quality Unit for its 503B Outsourcing Facility. This is a critical leadership role responsible for regulatory compliance, sterile drug manufacturing oversight, and quality systems governance within a high-visibility operation.
This position serves as the primary Subject Matter Expert (SME) for all regulatory and compliance matters related to 503B outsourcing facilities, USP
, USP
, and aseptic processing.
Sterile Manufacturing (503B / Aseptic Processing) Position Summary
The Director of Quality provides both strategic direction and hands-on leadership for sterile drug quality operations. This role oversees quality systems, batch release, compliance programs, and inspection readiness while ensuring adherence to FDA guidance, cGMP standards, and USP regulations.
Sterile Manufacturing (503B / Aseptic Processing) Key Responsibilities
Regulatory & Compliance Leadership
Serve as the technical authority for aseptic manufacturing within a 503B Outsourcing Facility Ensure full compliance with FDA 503B guidance, USP
, USP
, and cGMP (21 CFR 210/211) Maintain compliance with Wholesale Drug Distribution requirements Interpret and apply evolving regulatory guidance to quality systems and operations
Inspection & Audit Representation
Act as Lead Management Representative during FDA inspections, state board audits, and third-party assessments Lead inspection readiness and regulatory response strategies
Quality Operations Oversight
Direct Quality Operations for sterile drug manufacturing Oversee batch record review, product release, and disposition for compounded sterile preparations (CSPs) Ensure procedures support aseptic processing and sterile manufacturing standards
Quality Systems Management
Manage deviations, CAPA, change control, complaints, recalls, OOS/OOT investigations Approve and oversee validation protocols, qualification reports, and SOPs with a 503B compliance focus
Risk & Continuous Improvement
Drive a proactive, risk-based quality culture Ensure facility and process designs align with regulatory expectations
Sterile Manufacturing (503B / Aseptic Processing) Required Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field
Advanced degree (M.S., Pharm.D., MBA) preferred
8+ years of experience in aseptic processing of sterile drugs 5+ years in a quality leadership role Expert knowledge of:
FDA Section 503B requirements and guidance USP
, USP
, USP
Sterility Testing 21 CFR Parts 210/211 (cGMP) State Board of Pharmacy regulations for outsourcing facilities
Proven success leading FDA inspections and regulatory audits
Sterile Manufacturing (503B / Aseptic Processing) Key Competencies
Deep subject matter expertise in 503B quality systems Advanced knowledge of parenteral sterile drug manufacturing Strong leadership with hands-on execution capability Excellent risk management and regulatory decision-making skills Ability to thrive in a fast-paced, high-accountability environment
If interested, please email your resume to LKOPASZ@ALINESTAFFING.com or 5867107959