SolomonEdwards
This range is provided by SolomonEdwards. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $140,000.00/yr - $160,000.00/yr
Our growing pharmaceutical client is seeking a
Director of Quality
to join their
Dallas, TX
location.
This position is responsible for ensuring full compliance with FDA regulations, cGMP, USP standards, and state pharmacy requirements, while maintaining the highest levels of product safety, consistency, and quality. The ideal candidate is a hands‑on, strategic quality leader with extensive experience in aseptic manufacturing, packaging, and sterile compounding, preferably within a 503B organization.
Responsibilities of the Director of Quality
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
Requirements of the Director of Quality
Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering, or related
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
Salary $140k-$160k
On Site Daily
The specific compensation for this role will be determined based on the education, experience, location and skill set of the individual selected for this position.
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
Base pay range $140,000.00/yr - $160,000.00/yr
Our growing pharmaceutical client is seeking a
Director of Quality
to join their
Dallas, TX
location.
This position is responsible for ensuring full compliance with FDA regulations, cGMP, USP standards, and state pharmacy requirements, while maintaining the highest levels of product safety, consistency, and quality. The ideal candidate is a hands‑on, strategic quality leader with extensive experience in aseptic manufacturing, packaging, and sterile compounding, preferably within a 503B organization.
Responsibilities of the Director of Quality
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
Requirements of the Director of Quality
Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering, or related
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
Salary $140k-$160k
On Site Daily
The specific compensation for this role will be determined based on the education, experience, location and skill set of the individual selected for this position.
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