Director, Quality

Jubilant Draximage; Kirkland; On-site; CAD 120,000 - 180,000; Full time

Job summary

Jubilant Radiopharmacies is seeking an experienced Director, Quality to lead the Quality Unit across PET manufacturing, radiopharmacies, and CDMO operations. The role drives quality strategy, regulatory compliance, inspection readiness, and continuous improvement to ensure drug quality and patient safety.

The Director partners with Operations, Pharmacy, R&D, Supply Chain and regulators to strengthen performance.

Qualifications

• Bachelor of Science degree or equivalent required.
• 7–10 years of quality management experience in pharma or radiopharmaceuticals.
• Experience leading QA/QC in cGMP environments.
• Deep knowledge of BOP regulations, cGMP (21 CFR 211 & 212), and FDA guidelines.

Responsibilities

• Lead the pharmaceutical quality management system and drive improvements.
• Provide guidance on cGMP requirements and applicable standards (FDA, BOP, ISO, ICH).
• Lead Quality teams supporting PET manufacturing, radiopharmacies, and CDMO ops.
• Maintain independent quality unit oversight of materials, products, records, and labs.
• Lead audits, inspections readiness, investigations, CAPA, and risk management.
• Oversee investigations related to quality events and patient-safety incidents.
• Develop and present quality metrics and communicate to senior leaders and regulators.
• Represent Jubilant during regulatory interactions with authorities.

Skills

Quality leadership

Regulatory compliance

cGMP knowledge

Audits and CAPA

Cross-functional collaboration

Technical writing

Travel willingness

Education

Bachelor of Science degree or equivalent

Job description

Jubilant Radiopharmacies

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.

The Position

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.

Person Profile

• 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 CFR 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.