Quality Site Lead - Mobile, AL

Jubilant Pharma Limited; Mobile (AL); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Competitive compensation

Annual performance bonus

Generous vacation

401K matching

Job summary

Jubilant Pharma Limited is seeking a Site Quality Lead in Mobile, AL, to oversee quality assurance in our radiopharmaceutical operations. This role includes maintaining quality systems, supporting audits, and ensuring compliance with FDA regulations.

The ideal candidate holds a Bachelor's degree in a scientific field and has over 3 years of relevant experience. Join us in our commitment to patient safety and product quality.

We offer competitive compensation, an annual performance bonus, generous vacation, and 401K matching.

Qualifications

• 3+ years of experience in pharmaceutical quality assurance.
• Strong knowledge of cGMP and quality systems.
• In-depth understanding of GxP regulations and data integrity standards.

Responsibilities

• Maintain and improve quality systems including CAPA and change control.
• Support internal and external audits, including FDA inspections.
• Collaborate with Production and QC teams for quality standards.

Skills

FDA regulations knowledge

Quality assurance

Analytical thinking

Communication skills

Technical writing skills

Education

Bachelor’s degree in a scientific discipline

Tools

LIMS

MES

ERP

CDS

Job description

About Jubilant Radiopharmacies

At Jubilant Radiopharmacies, we support patient care by producing and delivering high-quality radiopharmaceutical products that help clinicians diagnose and treat disease. Our teams work with purpose, collaboration, and a strong commitment to safety and compliance. We value people, empower growth, and encourage a culture where individuals can do their best work.

Site Quality Lead

Location: Mobile, AL

Role Overview

We 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, 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 Offer

We want every team member to feel valued and supported. We offer competitive compensation, an annual performance bonus, generous vacation, and 401K matching.

Our Commitment to Inclusion

Jubilant Radiopharmacies is an equal opportunity employer. We welcome applicants from all backgrounds and are committed to building an inclusive workplace where every individual feels respected, supported, and able to succeed. We encourage people of all identities, abilities, ages, and experiences to apply.