Site Quality LeadLocation:Mobile, AL
Role OverviewWe are seeking a Site Quality Lead to help ensure our radiopharmaceutical manufacturing operations meet FDA, cGMP, and internal quality standards. In this role, you will oversee quality systems, provide support to sterile manufacturing operations, and partner closely with operations, QC, and corporate quality teams. This position is an excellent fit for someone who is detail-oriented, knowledgeable in quality compliance, and motivated to improve processes that directly impact patient safety.
Key Responsibilities- Maintain and improve quality systems, including CAPA, change control, deviations, complaints, and document control.
- Support internal and external audits, including FDA inspections and customer audits.
- Ensure timely completion of quality events and implementation of effective corrective actions.
- Monitor compliance with 21 CFR Part 212 and applicable USP chapters.
- Review batch records, QC data, and manufacturing documentation for accuracy and compliance.
- Perform batch trend tracking and upload batch information required by customers.
- Support regulatory submissions and responses to health authority inquiries.
- May serve as the Radiation Safety Officer.
- Collaborate with Production and QC teams to ensure aseptic processing standards are met.
- Support root cause analysis and write investigation reports for quality events.
- Participate in environmental monitoring review, trending, and sterility assurance activities, including media fill validations.
- Develop and deliver GMP and compliance training.
- Write and update SOPs, protocols, and reports in alignment with regulatory expectations.
- Identify and implement process improvements that enhance quality and operational efficiency.
- Partner with Corporate Quality, Supply Chain, Radiation Safety, Engineering, and Operations to support site readiness and compliance.
Qualifications- Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy, Engineering).
- 3+ years of experience in pharmaceutical quality assurance or quality compliance, preferably in sterile or radiopharmaceutical manufacturing.
- Strong knowledge of FDA regulations, cGMP, and quality systems.
- In-depth understanding of GxP regulations, FDA 21 CFR Part 11, 21 CFR Part 211, 21 CFR Part 212, USP < 825>, and global data integrity standards.
- Experience with electronic systems such as LIMS, MES, ERP, or CDS.
- Strong communication, organization, analytical thinking, and technical writing skills.
- Ability to work independently and manage multiple priorities effectively.
- Ability to collaborate well with cross-functional stakeholders.
What We OfferWe want every team member to feel valued and supported. We offer competitive compensation, an annual performance bonus, generous vacation, and 401K matching.
