Nesco Resource
Associate Director of Quality Assurance
Nesco Resource, Phoenix, Arizona, United States, 85003
Associate Director of Quality Assurance
Full Time | On‑Site | Salary: $100,000–$125,000
About the Company A fast‑growing pharmaceutical manufacturer is seeking an Associate Director of Quality Assurance to oversee quality systems and regulatory compliance across its sterile production operations. The company specializes in producing high‑quality pharmaceutical products for healthcare organizations nationwide and maintains a strong focus on cGMP standards, process reliability, and continuous improvement.
Position Summary The Associate Director of Quality Assurance will provide both strategic and hands‑on leadership for the QA function, ensuring all products, processes, and documentation meet applicable regulatory requirements. This role supports day‑to‑day oversight of manufacturing and laboratory activities, leads QA personnel, and drives the maturity of the company’s quality systems. Candidates with experience in sterile or aseptic manufacturing environments are strongly preferred.
Key Responsibilities
Lead QA operations across multiple production and laboratory areas, ensuring consistent alignment with internal quality standards and federal regulations.
Manage batch record review, product disposition, deviation investigations, and CAPA processes.
Ensure ongoing compliance with FDA 21 CFR regulations, cGMP requirements, and applicable industry standards such as ISO 9001.
Conduct internal audits and support external inspections from regulatory agencies and customer auditors.
Collaborate with cross‑functional teams (Manufacturing, QC, Validation, Engineering) to resolve quality issues and maintain a compliant production environment.
Oversee training programs related to cGMP, aseptic practices, and quality procedures.
Review and approve SOPs, validation protocols, and other controlled documents.
Provide leadership for cleanroom oversight, environmental monitoring programs, and process validation activities.
Participate in risk assessments and support root‑cause investigations for quality‑related events.
Mentor and develop QA staff to support team growth and performance.
Qualifications Required:
Bachelor’s degree in Chemistry, Microbiology, Pharmacy, or a related scientific field.
7+ years of quality experience in pharmaceutical manufacturing or another FDA‑regulated environment.
Strong knowledge of cGMP, quality systems, and regulatory expectations.
Demonstrated success leading QA teams or managing key quality functions.
Exceptional communication, documentation, and problem‑solving skills.
Preferred:
Experience in sterile/aseptic operations or parenteral manufacturing.
Advanced degree (MS, PharmD, MBA, or similar).
Familiarity with QMS software, electronic batch records, LIMS, or related systems.
Prior involvement in regulatory inspections or customer audits.
This is a fully on‑site role requiring routine interaction with production, laboratory, and cleanroom areas. Occasional flexibility may be needed during audits, investigations, or time‑sensitive production activities. Some travel between company locations may be required.
Benefits
Salary range:
$100,000–$125,000 , depending on experience.
Annual performance bonus eligibility.
Medical, dental, and vision coverage.
401(k) with employer match.
Paid time off and company‑observed holidays.
Ongoing training and professional development opportunities.
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About the Company A fast‑growing pharmaceutical manufacturer is seeking an Associate Director of Quality Assurance to oversee quality systems and regulatory compliance across its sterile production operations. The company specializes in producing high‑quality pharmaceutical products for healthcare organizations nationwide and maintains a strong focus on cGMP standards, process reliability, and continuous improvement.
Position Summary The Associate Director of Quality Assurance will provide both strategic and hands‑on leadership for the QA function, ensuring all products, processes, and documentation meet applicable regulatory requirements. This role supports day‑to‑day oversight of manufacturing and laboratory activities, leads QA personnel, and drives the maturity of the company’s quality systems. Candidates with experience in sterile or aseptic manufacturing environments are strongly preferred.
Key Responsibilities
Lead QA operations across multiple production and laboratory areas, ensuring consistent alignment with internal quality standards and federal regulations.
Manage batch record review, product disposition, deviation investigations, and CAPA processes.
Ensure ongoing compliance with FDA 21 CFR regulations, cGMP requirements, and applicable industry standards such as ISO 9001.
Conduct internal audits and support external inspections from regulatory agencies and customer auditors.
Collaborate with cross‑functional teams (Manufacturing, QC, Validation, Engineering) to resolve quality issues and maintain a compliant production environment.
Oversee training programs related to cGMP, aseptic practices, and quality procedures.
Review and approve SOPs, validation protocols, and other controlled documents.
Provide leadership for cleanroom oversight, environmental monitoring programs, and process validation activities.
Participate in risk assessments and support root‑cause investigations for quality‑related events.
Mentor and develop QA staff to support team growth and performance.
Qualifications Required:
Bachelor’s degree in Chemistry, Microbiology, Pharmacy, or a related scientific field.
7+ years of quality experience in pharmaceutical manufacturing or another FDA‑regulated environment.
Strong knowledge of cGMP, quality systems, and regulatory expectations.
Demonstrated success leading QA teams or managing key quality functions.
Exceptional communication, documentation, and problem‑solving skills.
Preferred:
Experience in sterile/aseptic operations or parenteral manufacturing.
Advanced degree (MS, PharmD, MBA, or similar).
Familiarity with QMS software, electronic batch records, LIMS, or related systems.
Prior involvement in regulatory inspections or customer audits.
This is a fully on‑site role requiring routine interaction with production, laboratory, and cleanroom areas. Occasional flexibility may be needed during audits, investigations, or time‑sensitive production activities. Some travel between company locations may be required.
Benefits
Salary range:
$100,000–$125,000 , depending on experience.
Annual performance bonus eligibility.
Medical, dental, and vision coverage.
401(k) with employer match.
Paid time off and company‑observed holidays.
Ongoing training and professional development opportunities.
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