A-Line Staffing is now hiring a Quality Director in Dallas, TX!
The Quality Director will be working for a respected pharmaceutical manufacturing organization and has strong long-term growth potential. See additional details below.
Quality Director Highlights Pay Rate: $160,000-$170,000 annually
Schedule:
Monday through Friday
Work Setting:
Onsite position
Employment Type:
Full-Time, Exempt
Responsibilities Serve as the senior Quality leader and technical Subject Matter Expert (SME) for sterile parenteral manufacturing within a 503B Outsourcing Facility.
Own and execute regulatory strategy in alignment with FDA guidance, USP
, USP
, USP
, and cGMP requirements (21 CFR Parts 210/211).
Lead all regulatory inspections and external audits as the primary Management Representative.
Drive continuous inspection readiness across facilities, documentation, training, and validation programs.
Translate regulatory and compliance requirements into scalable quality systems and operational controls.
Oversee batch record review, product disposition, and release of compounded sterile products.
Lead deviation management, CAPA, change control, complaints, investigations (OOS/OOT), and recall readiness.
Ensure SOPs, validation protocols, qualification documentation, and environmental monitoring programs meet regulatory expectations.
Review and approve validation strategies for equipment, processes, utilities, and facilities.
Establish data-driven quality metrics and continuous improvement initiatives.
Maintain compliance with Wholesale Drug Distribution regulations and licensing requirements.
Ensure traceability, documentation integrity, and audit readiness across distribution operations.
Build, mentor, and develop high-performing Quality teams.
Promote a culture of accountability, compliance ownership, and operational excellence.
Requirements Bachelor’s degree in Engineering, Life Sciences, or a related discipline required.
Master’s degree, PharmD, or MBA preferred.
Minimum
8+ years
of hands-on experience in aseptic processing of sterile drugs for human use.
Minimum
5+ years
of progressive leadership experience managing Quality functions or organizations.
Expert-level knowledge of: FDA Section 503B and related guidance
USP
, USP
, and USP
State Board of Pharmacy regulations applicable to outsourcing facilities
21 CFR Parts 210/211 and cGMP requirements
Proven success leading FDA inspections and regulatory audits.
Strong technical writing, documentation, and cross-functional leadership skills.
Benefits Available Benefits are available to full-time employees after 90 days of employment.
A 401(k) with company match is available for full-time employees with 1 year of service on eligibility dates.
If you are interested in this
Quality Director
position,
APPLY
, or contact
kvaughn@alinestaffing.com
for more information.
Quality Director Highlights Pay Rate: $160,000-$170,000 annually
Schedule:
Monday through Friday
Work Setting:
Onsite position
Employment Type:
Full-Time, Exempt
Responsibilities Serve as the senior Quality leader and technical Subject Matter Expert (SME) for sterile parenteral manufacturing within a 503B Outsourcing Facility.
Own and execute regulatory strategy in alignment with FDA guidance, USP
, USP
, USP
, and cGMP requirements (21 CFR Parts 210/211).
Lead all regulatory inspections and external audits as the primary Management Representative.
Drive continuous inspection readiness across facilities, documentation, training, and validation programs.
Translate regulatory and compliance requirements into scalable quality systems and operational controls.
Oversee batch record review, product disposition, and release of compounded sterile products.
Lead deviation management, CAPA, change control, complaints, investigations (OOS/OOT), and recall readiness.
Ensure SOPs, validation protocols, qualification documentation, and environmental monitoring programs meet regulatory expectations.
Review and approve validation strategies for equipment, processes, utilities, and facilities.
Establish data-driven quality metrics and continuous improvement initiatives.
Maintain compliance with Wholesale Drug Distribution regulations and licensing requirements.
Ensure traceability, documentation integrity, and audit readiness across distribution operations.
Build, mentor, and develop high-performing Quality teams.
Promote a culture of accountability, compliance ownership, and operational excellence.
Requirements Bachelor’s degree in Engineering, Life Sciences, or a related discipline required.
Master’s degree, PharmD, or MBA preferred.
Minimum
8+ years
of hands-on experience in aseptic processing of sterile drugs for human use.
Minimum
5+ years
of progressive leadership experience managing Quality functions or organizations.
Expert-level knowledge of: FDA Section 503B and related guidance
USP
, USP
, and USP
State Board of Pharmacy regulations applicable to outsourcing facilities
21 CFR Parts 210/211 and cGMP requirements
Proven success leading FDA inspections and regulatory audits.
Strong technical writing, documentation, and cross-functional leadership skills.
Benefits Available Benefits are available to full-time employees after 90 days of employment.
A 401(k) with company match is available for full-time employees with 1 year of service on eligibility dates.
If you are interested in this
Quality Director
position,
APPLY
, or contact
kvaughn@alinestaffing.com
for more information.