Director, Quality

Jubilant Pharma, LLC; Pennsylvania; On-site; USD 140,000 - 210,000; Full time

Job summary

Jubilant Radiopharmacies is seeking an experienced Director of Quality to lead the Quality Unit supporting PET manufacturing, radiopharmacies, and CDMO operations. This role defines quality strategy, regulatory compliance, inspection readiness, and continuous improvement across multiple locations.

The Director will approve or reject materials and procedures impacting drug quality, partner with senior leadership, operations, pharmacy, R&D, supply chain, regulators, and customers to strengthen

Qualifications

• Bachelor's degree in Science or equivalent.
• 7–10 years in Quality management in pharmaceutical/radiopharmaceutical industries.
• Deep knowledge of cGMP, 21 CFR 211 & 212, FDA guidelines for radiopharma.
• Experience leading QA/QC programs, audits, investigations, CAPA.
• Strong leadership, communication, and cross-functional collaboration.
• Willingness to travel to multiple facilities as needed.
• Background check and pre-employment drug test required.
• Driver's license and ability to operate a vehicle.

Responsibilities

• Lead and continuously improve the Quality Management System (QMS).
• Provide guidance on cGMP requirements and regulatory standards (FDA, BOP, ISO/ICH).
• Lead QA/QC teams across PET manufacturing, radiopharmacies, and CDMO operations.
• Maintain independent Quality Unit oversight of materials, records, labs, and third parties.
• Oversee audits, inspections, CAPA, investigations, and risk management programs.
• Develop and present quality metrics, trends, and risk assessments to leadership.
• Represent Jubilant Radiopharmacies to federal and state regulators.
• Mentor and develop Quality staff across multiple locations.

Skills

Quality leadership

cGMP knowledge

Regulatory inspections

Cross-functional collaboration

Audits

CAPA

Education

Bachelor's degree (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.

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.