Director of Quality

Jubilant Radiopharma; United States; On-site; USD 180,000 - 280,000; Full time

Benefits offered by this job

Annual performance bonus

Generous vacation

401K matching

Job summary

Jubilant Radiopharmacies is seeking an experienced Director, Quality to lead the Quality Unit across PET manufacturing, radiopharmacies, and CDMO operations, ensuring compliance and patient safety.

The role drives quality strategy, regulatory readiness, CAPA, and continuous improvement, partnering with Operations, Pharmacy, R&D, and regulators to strengthen cGMP programs across multiple sites and locations nationwide.

Travel to facilities is required to support inspections and audits as needed.

Qualifications

• 7–10 years of Quality management experience in the pharmaceutical or radiopharmaceutical industry.
• Experience leading QA/QC compliance programs in cGMP-regulated operations.
• In-depth knowledge of BOP regulations, 21 CFR 211 & 212, and FDA guidelines related to radiopharmaceuticals, compounding, contamination control, and facility design.
• Experience with investigations, root-cause analysis, CAPA, audits, quality systems, and regulatory inspections.
• Strong leadership, communication, technical writing, and cross-functional collaboration skills.

Responsibilities

• Lead and continuously improve the pharmaceutical quality management system.
• Provide guidance on cGMP requirements and applicable FDA, Board of Pharmacy, ISO, and ICH standards.
• Lead Quality teams supporting PET manufacturing, radiopharmacies, and CDMO operations.
• Maintain independent Quality Unit oversight of materials, products, procedures, production records, laboratory testing, and third-party activities.
• Lead audit, inspection-readiness, investigation, CAPA, and quality-risk-management programs.
• Oversee investigations related to quality events, technical issues, patient-safety incidents, and adverse drug events.
• Develop and present quality metrics, trends, risks, and recommendations to senior leaders, regulators, and customers.
• Represent Jubilant during interactions with federal and state regulatory authorities.
• Partner with Operations and Pharmacy leaders to address compliance issues and implement sustainable corrective actions.
• Monitor regulatory developments and translate new requirements into policies, procedures, training, and controls.
• Lead, coach, and develop Quality professionals across multiple locations.
• Manage Board of Pharmacy license applications and renewals for applicable facilities.
• Provide clinical pharmacy support to pharmacists as requested.
• Participate in relevant industry and professional organizations.
• Perform other related duties as assigned.

Skills

Leadership

Regulatory knowledge

Quality management

Cross-functional collaboration

Technical writing

Communication

Team development

Project management

Education

Bachelor of Science

Job description

Jubilant Radiopharmacies provides radiopharmaceutical products and services that support nuclear medicine and patient care. We are looking for an experienced Quality leader to strengthen our quality systems, guide our teams, and help ensure safe, compliant operations across our network.

Role Overview

The Director, Quality leads the Quality Unit supporting PET manufacturing, nuclear pharmacies, and CDMO operations. This position is responsible for quality strategy, regulatory compliance, inspection readiness, quality risk management, and continuous improvement across multiple locations.

Consistent with cGMP requirements, the Director has the authority to approve or reject materials, products, records, and procedures that may affect drug quality. The role partners with senior leaders, Operations, Pharmacy, R&D, Supply Chain, regulators, and customers to strengthen quality performance and support patient safety.

Key Responsibilities

• Lead and continuously improve the pharmaceutical quality management system.
• Provide guidance on cGMP requirements and applicable FDA, Board of Pharmacy, ISO, and ICH standards.
• Lead Quality teams supporting PET manufacturing, radiopharmacies, and CDMO operations.
• Maintain independent Quality Unit oversight of materials, products, procedures, production records, laboratory testing, and third-party activities.
• Lead audit, inspection-readiness, investigation, CAPA, and quality-risk-management programs.
• Oversee investigations related to quality events, technical issues, patient-safety incidents, and adverse drug events.
• Develop and present quality metrics, trends, risks, and recommendations to senior leaders, regulators, and customers.
• Represent Jubilant during interactions with federal and state regulatory authorities.
• Partner with Operations and Pharmacy leaders to address compliance issues and implement sustainable corrective actions.
• Monitor regulatory developments and translate new requirements into policies, procedures, training, and controls.
• Lead, coach, and develop Quality professionals across multiple locations.
• Manage Board of Pharmacy license applications and renewals for applicable facilities.
• Provide clinical pharmacy support to pharmacists as requested.
• Participate in relevant industry and professional organizations.
• Perform other related duties as assigned.

Qualifications

• Bachelor of Science degree or equivalent.
• 7 to 10 years of Quality management experience in the pharmaceutical or radiopharmaceutical industry.
• Experience leading QA/QC compliance programs in cGMP-regulated operations.
• In-depth knowledge of BOP regulations, cGMP standards (i.e. 21 FCR 211 & 212), and FDA guidelines related to compounding pharmacies, radiopharmaceutical production, contamination control, facility and equipment design and qualification.
• Experience with investigations, root-cause analysis, CAPA, audits, quality systems, and regulatory inspections.
• Strong leadership, communication, technical writing, and cross-functional collaboration skills.
• Experience leading and developing teams across multiple locations.
• Appropriate training and experience in patient safety requirements of pharmacy operations and experience in performing compliance audits.
• Knowledge of radiopharmaceutical compounding and dispensing experience is desired.
• Willingness to routinely travel to facility locations as needed.
• Must be able to successfully pass company’s background check and pre-employment drug test.
• Ability to operate a vehicle and maintain a valid driver’s license also required.

Compensation and Benefits

We offer competitive compensation, an annual performance bonus, generous vacation, and 401K matching.

Bring Your Quality Leadership to Jubilant

If you are motivated by complex Quality challenges and want to strengthen systems that support product quality and patient safety, we encourage you to apply.

Jubilant is committed to an inclusive and accessible workplace. Employment decisions are made without regard to any characteristic protected by applicable federal, state, or local law. Reasonable accommodations are available throughout the recruitment and employment process.