SolomonEdwards
Our growing pharmaceutical client is seeking a
Director of Quality
to join their
Dallas, TX
location.
Base Pay Range $140,000.00/yr – $160,000.00/yr
Responsibilities
Oversee all Quality Operations and Compliance functions, ensuring efficient and compliant daily operations
Act as the site Quality leader, defining strategy, setting standards, and driving continuous improvement
Lead batch record review, release, and disposition of compounded sterile products (CSPs)
Ensure adherence to FDA, cGMP, USP
,
,
, and state regulatory requirements
Manage deviation/CAPA, change control, complaint, and recall processes
Act as the primary site representative during FDA and state board inspections and external audits
Lead internal audits and oversee timely closure of findings
Review and approve validation protocols, qualification reports, SOPs, and regulatory submissions
Collaborate with manufacturing, engineering, and operations to maintain quality across all departments
Qualifications
Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering, or related field
10+ years of pharmaceutical quality experience, including 5+ years in a leadership capacity
Deep understanding of 21 CFR Parts 210/211 and Section 503B regulations, cGMP for sterile manufacturing and aseptic processing, USP
,
,
and related state pharmacy standards
Proven success managing quality systems in sterile compounding or manufacturing environments
Demonstrated experience with FDA inspections and regulatory audits
Strong leadership, risk assessment, and decision‑making skills
Excellent written and verbal communication abilities
Employment Type Direct hire, Full‑time, On Site Daily
Senior Level Director
Industry Pharmaceutical Manufacturing
Legal Notice SolomonEdwardsGroup, LLC is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, or protected veteran status.
SolomonEdwardsGroup, LLC adheres to the California Consumer Privacy Act (CCPA). Your privacy is important to us, and we never sell your data to third parties. Personal information is only collected to match applicants with job opportunities. For more information on your rights, click here: https://solomonedwards.com/privacy-policy/#ccpa
#J-18808-Ljbffr
Director of Quality
to join their
Dallas, TX
location.
Base Pay Range $140,000.00/yr – $160,000.00/yr
Responsibilities
Oversee all Quality Operations and Compliance functions, ensuring efficient and compliant daily operations
Act as the site Quality leader, defining strategy, setting standards, and driving continuous improvement
Lead batch record review, release, and disposition of compounded sterile products (CSPs)
Ensure adherence to FDA, cGMP, USP
,
,
, and state regulatory requirements
Manage deviation/CAPA, change control, complaint, and recall processes
Act as the primary site representative during FDA and state board inspections and external audits
Lead internal audits and oversee timely closure of findings
Review and approve validation protocols, qualification reports, SOPs, and regulatory submissions
Collaborate with manufacturing, engineering, and operations to maintain quality across all departments
Qualifications
Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering, or related field
10+ years of pharmaceutical quality experience, including 5+ years in a leadership capacity
Deep understanding of 21 CFR Parts 210/211 and Section 503B regulations, cGMP for sterile manufacturing and aseptic processing, USP
,
,
and related state pharmacy standards
Proven success managing quality systems in sterile compounding or manufacturing environments
Demonstrated experience with FDA inspections and regulatory audits
Strong leadership, risk assessment, and decision‑making skills
Excellent written and verbal communication abilities
Employment Type Direct hire, Full‑time, On Site Daily
Senior Level Director
Industry Pharmaceutical Manufacturing
Legal Notice SolomonEdwardsGroup, LLC is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, or protected veteran status.
SolomonEdwardsGroup, LLC adheres to the California Consumer Privacy Act (CCPA). Your privacy is important to us, and we never sell your data to third parties. Personal information is only collected to match applicants with job opportunities. For more information on your rights, click here: https://solomonedwards.com/privacy-policy/#ccpa
#J-18808-Ljbffr