Quality and Compliance Specialist

Quality & Compliance Specialist - Radiopharmacy Focus

Location:home-office

Travel:Up to 30% across pharmacy locations and Jubilant sites

Are you passionate about quality and compliance in the radiopharmaceutical space? Jubilant Radiopharmacies is seeking aQuality & Compliance Specialistto play a pivotal role in ensuring regulatory excellence across our operations-from manufacturing to distribution of life-saving radiopharmaceuticals.

This is a unique opportunity to join a dynamic team where your expertise inFDA 21 CFR 212, USP <797> and <825>, andmanufacturing processeswill directly impact patient safety and product integrity.

What You'll Do

Regulatory & Quality Leadership

• Stay ahead of evolving FDA and global regulations impacting radiopharmacy and aseptic manufacturing.
• Lead gap assessments and interpret regulatory changes to ensure proactive compliance.

Quality Systems Oversight

• Manage core quality systems: CAPA, change control, deviations, complaints, document control, and training.
• Drive continuous improvement and ensure systems are audit-ready.

Audit & Inspection Readiness

• Conduct internal audits and prepare teams for regulatory inspections.
• Serve as a key contributor during FDA and other agency visits.

Radiopharmacy-Specific Compliance

• Ensure adherence toUSP <797> and <825>,FDA 21 CFR 212, and other radiopharmaceutical standards.
• Support validation activities for equipment, cleaning, analytical methods, and computerized systems.

Supplier & Tech Transfer Support

• Oversee supplier qualification, SCARs, and quality agreements.
• Collaborate on tech transfer projects with a focus on quality and compliance.

Data Integrity & Governance

• Champion ALCOA+ principles across departments.
• Lead initiatives to strengthen data integrity and ensure compliance with Part 11 and Annex 11.

Training & Cross-Functional Collaboration

• Develop and deliver training programs on quality and compliance.
• Partner with QA, Regulatory, Supply Chain, and Operations to align on quality goals.

What You Bring

• BSc in Science, Chemical Engineering, or equivalent experience.
• 5+ yearsin pharmaceutical or radiopharmaceutical quality systems.
• Proven experience withFDA inspectionsandaseptic manufacturing.
• Deep knowledge ofGxP,FDA 21 CFR Part 11,USP <797>/<825>, andEU Annex 11.
• Familiarity with electronic systems (LIMS, MES, ERP, CDS).
• Strong technical writing, analytical thinking, and organizational skills.
• A collaborative mindset and ability to manage multiple priorities.

Why Jubilant Radiopharmacies?

We're a leader in nuclear medicine and radiopharmaceuticals, committed to innovation, safety, and quality. Join us and be part of a mission-driven organization that's improving lives through precision diagnostics and therapies.