Director of Quality

Join Our Team as the Director of Quality at Jubilant Radiopharma!

About the Role: As the Director of Quality, you will lead the development, implementation, and continuous improvement of our quality management systems, ensuring that our pharmaceutical operations exceed all federal, state, and organizational regulatory requirements. This role involves strategizing and enforcing comprehensive policies and procedures to guarantee compliance and operational excellence. You will play a pivotal role in risk assessment, quality assurance, and decision-making, often navigating complex scenarios to uphold the highest standards of product safety, efficacy, and regulatory compliance.

Key Responsibilities:

• Develop and uphold a comprehensive quality management framework in compliance with Board of Pharmacy, FDA, ISO, ICH standards.
• Lead and manage quality assurance teams across PET Manufacturing and Radiopharmacies.
• Establish and sustain a quality audit program to ensure adherence to FDA and Board of Pharmacy regulations.
• Oversee the reporting of quality and safety-related incidents in PET radiopharmaceutical manufacturing and nuclear pharmacy operations.
• Present quality and safety metrics to senior management, regulatory agencies, and customers.
• Coordinate incident investigations and responses to patient safety incidents and adverse drug events.
• Recruit, train, and mentor quality assurance personnel; assess performance and provide guidance.
• Represent Jubilant Radiopharma in dealings with federal and state regulatory bodies.
• Produce reports on non-compliance issues and consult with Operations to address discrepancies.
• Stay informed on FDA regulatory changes and update policies and procedures accordingly.
• Participate in industry associations and boards to keep up-to-date with the profession and represent Jubilant Radiopharma.
• Provide clinical pharmacy support as requested.
• Advise the Corporate Compliance Committee on compliance issues and recommend resolutions.
• Manage the process of obtaining and renewing Board of Pharmacy licenses for various facilities.
• Participate in meetings to integrate activities, resolve issues, and stay informed on new developments.

Qualifications:

• Bachelor’s degree in a related field and 5-7 years of experience in quality management roles within the pharmaceutical or radiopharmaceutical industry, preferably in nuclear pharmacy and radiopharmaceutical diagnostics and therapy.
• Experience overseeing QA/QC compliance programs.
• Training and experience in patient safety requirements of pharmacy operations and performing compliance audits.
• Knowledge of radiopharmaceutical compounding and dispensing.
• In-depth knowledge of BOP regulations, cGMP standards (i.e., 21 CFR 212), and FDA guidelines related to compounding pharmacies and radiopharmaceutical production.
• Ability to establish priorities, work independently, and complete work with minimal supervision.
• Proven track record of managing quality systems and leading quality improvement initiatives.
• Strong leadership skills with the ability to manage and motivate teams across multiple sites.
• Excellent verbal communication skills and ability to work effectively with team members across various operational groups.
• Strong technical writing skills for developing policies and procedures related to quality, safety, and pharmacy dispensing.
• Ability to develop and facilitate training both on-site and remotely.
• Willingness to travel to facility locations as needed.
• Must pass a background check and pre-employment drug test.
• Valid driver’s license and ability to operate a vehicle required.

Why Join Jubilant Radiopharma?

• Be part of a dynamic team dedicated to advancing radiopharmaceutical science.
• Engage in challenging and meaningful work with a significant impact on patient safety and product quality.
• Opportunities for professional growth and development within a leading company in the radiopharmaceutical industry.

Apply today to take the next step in your career with Jubilant Radiopharma!