Senior Manager, Quality Compliance - cGMP

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.

We have an exciting opportunity for aSenior Manager, Quality Compliance - cGMP who is passionate about making a difference in patients' lives.

We offer YOU:

• A career, not just a job!

• Career growth and development opportunities

• Supportive work culture

• Competitive base salary

• Medical, dental and vision

• 401(k) with company matching

• Paid Time Off and paid holidays

• Short and long-term disability coverage

What YOU Will Do:

• Manage the cGMP Compliance group and team members with indirect oversight of field operations team members responsible for Quality management in our manufacturing operations;
• Maintain expert level of knowledge of FDA, USP, cGMP Quality System Standards, and other applicable regulations, the regulatory process, and the application of these regulations to radiopharmaceuticals;
• Communicate risks and gaps to appropriate Jubilant Quality management;
• Provide Quality oversight of all FDA related documentation to assure accuracy and compliance with FDA guidelines; may include oversight of consultant staff, as applicable. Ensure consultant work meets both internal Jubilant Radiopharma standards and FDA requirements for submission;
• Develop, manage and lead the cGMP compliance program and overall Quality System for all JDR manufacturing facilities from a Quality perspective;
• Develop and present training materials to assure competency of operational team members in cGMP compliance issues and specific quality programs;

What YOU Will Bring:

• Three (3) + years' experience in cGMP pharmaceutical/biotechnology/PET operations required, with previous responsibility for directing overall Compliance Program and QA/QC ;
• Appropriate training and experience in FDA Law and regulations and cGMPs (including but not limited to validation, cleaning, process and information technology); auditing of pharmaceutical operations and auditing of QA/QC laboratories and procedures required;
• Minimum of five (5) years' experience in FDA cGMP regulations, validation process design and control, writing effective SOP's, change control, auditing, document management, and leading and responding to FDA and outside vendor audits;
• Knowledge of PET radiopharmaceutical production, regulation and application experience preferred;
• Expert knowledge of requirements for software, equipment and process validation with specific validation experience;
• Ability to establish priorities, work independently, and complete necessary work functions with a minimum of supervision; Requires ability to define and solve problems, collect data, establish facts and draw conclusions using sound judgment;

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 as a Senior Manager, Quality Compliance - cGMP!

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