What are the responsibilities and job description for the Quality and Compliance Specialist position at Jubilant Draxlmage Radiopharmacies Inc, dba Jubilant Radiopharma?
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.
