Job Description

Are you ready to join an organization that provides a dynamic, customer-focused environment?

Join us at Jubilant Radiopharma, where we combine global clinical expertise with a leading pharmacy network to support our customers and advance the practice of nuclear medicine. As an industry-leading pharmaceutical company, we specialize in developing, manufacturing, and distributing high-quality diagnostic and therapeutic agents. Our mission is to improve lives through nuclear medicine on a global scale.

Position Summary

The Senior Director of Quality is responsible for the development, implementation, and continuous improvement of the Quality Management System (QMS) across all pharmaceutical operations. This role ensures compliance with cGMP , FDA , Board of Pharmacy , and ISO/ICH standards. The Director will lead quality teams across PET manufacturing , radiopharmacies , and CDMO operations, and serve as the primary authority on quality decisions, risk assessments, and regulatory compliance.

Key Responsibilities

Strategic Leadership & Compliance Oversight

• Lead the Quality Unit with full authority to approve or reject all materials, products, and procedures impacting drug quality.
• Serve as the primary advisor to executive leadership on all matters related to cGMP, regulatory compliance, and quality risk management.
• Develop and implement a comprehensive QMS aligned with 21 CFR Parts 211 & 212, FDA, Board of Pharmacy, ISO, and ICH standards.
• Ensure compliance across internal operations and third-party contractors, including CDMO and PET manufacturing partners.

Audit & Inspection Readiness

• Establish and manage a robust internal audit program to ensure continuous compliance with FDA and Board of Pharmacy regulations.
• Lead preparation and response efforts for regulatory inspections and customer audits.
• Oversee the pharmacy audit team and ensure corrective actions are implemented and sustained across the JDR network.

Quality Operations & Documentation

• Oversee review and approval of batch records, laboratory data, SOPs, deviations, CAPAs, and change controls.
• Ensure all quality-related documentation is accurate, complete, and compliant with data integrity standards.
• Maintain and report quality metrics to senior leadership, regulatory agencies, and customers.

Incident Management & Patient Safety

• Lead investigations into quality incidents, adverse drug events, and patient safety concerns.
• Coordinate timely and effective responses to regulatory bodies and customers.
• Ensure root cause analysis and preventive actions are implemented and monitored.

Cross-Functional Collaboration

• Partner with Operations, R&D, Regulatory Affairs, and Supply Chain to embed quality into all stages of product development and manufacturing.
• Collaborate with Regional Operations Directors and Pharmacy Managers to address recurring compliance issues and implement sustainable improvements.

Talent Development & Team Leadership

• Recruit, train, and mentor quality professionals across multiple sites.
• Conduct performance evaluations, provide coaching, and support career development.
• Manage staffing plans, succession planning, and organizational development for the Quality function.

Regulatory Intelligence & Policy Development

• Monitor evolving regulatory requirements and industry trends, particularly in nuclear pharmacy and radiopharmaceuticals.
• Update internal policies and procedures to reflect new regulations and ensure organization-wide implementation.
• Represent the company in industry associations, boards, and regulatory forums.

Licensing & Compliance Governance

• Oversee the process for obtaining and renewing Board of Pharmacy licenses for all facilities.
• Serve as Chair and Subject Matter Expert for the Corporate Compliance Committee.
• Provide regular updates on compliance status, risks, and mitigation strategies.

Required Qualifications

• Bachelor’s degree in Pharmaceutical Sciences , Life Sciences , or related field.
• 10–15 years of progressive experience in pharmaceutical quality assurance , with a strong preference for radiopharmaceutical or nuclear pharmacy experience.
• Deep knowledge of cGMP , FDA regulations , BOP standards , and compounding pharmacy compliance .
• Proven leadership in managing QA/QC programs , regulatory audits , and compliance investigations .
• Strong technical writing, communication, and team leadership skills.
• Willingness to travel to multiple facility locations as needed.

At Jubilant Radiopharma, we champion an inclusive workplace that treasures diverse perspectives, experiences, and backgrounds. We are committed to building a diverse yet inclusive workplace that is representative of the marketplace and the communities in which the Company operates.

Jubilant Radiopharma is proud to be an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status about public assistance, genetic status or any other status protected by federal, state or local law.

If qualified individuals with a disability need assistance in applying for this position, call Human Resources at 407-455-6700 informing us regarding the nature of your request and providing your contact information.

We look forward to speaking with you about this exciting new career opportunity, apply today!

Job Tags

Similar Jobs