Vice President Quality

AtomVie Global Radiopharma Inc. is a global leading GMP manufacturer and distributer of clinical and commercial radiopharmaceuticals. We work with our partners to empower the next generation radiotherapeutics for the detection and treatment of cancer and human diseases.

**About the Role**

The **Vice President Quality** is responsible for AtomVie Global Radiopharma (AtomVie)'s product quality and safety, maintaining regulatory compliance, and driving the company's quality culture and vision. Working closely with the CEO, they establish and uphold quality standards for clinical and commercial manufacturing, overseeing various departments including Quality Assurance, Quality Control, Microbiology labs, Validation, and Analytical Development. The VP Quality also collaborates with other key functional areas such as Operations, Regulatory Affairs, Business Development, HR, and IT & Administration. They are accountable for quality aspects of expansion and transition plans, as well as GMP activities at the current location, including facility decommissioning.

This is accomplished through the management of approximately 4 direct reports and over 40 indirect reports. The Incumbent will be reviewed on our core values based on quality, integrity, innovation, striving for results and safety.

**What You Will Do**
- Directs, develops, and mentors a team of professionals for all aspects of quality and compliance at AtomVie while creating a development plan for staff retention and engagement.
- Provides oversight to ensure full compliance of sterile drug manufacturing in accordance with cGMP regulations and guidelines set forth by Health Canada, FDA, EMA, and industry best practices.
- Leads regulatory and client audits and assumes responsibility for responding to audit reports and implementing corrective actions in a timely manner.
- Ensures the accuracy and compliance of data and information provided to auditing / regulatory bodies, clients, management, and other stakeholders.
- Ensures the functions under his/her oversight are staffed and scheduled to enable just-in-time product release.
- Drives teams to ensure the timely implementation and close out of all quality systems and documentation supporting new processes, changes and routine manufacturing.
- Continually drives a culture of quality throughout the organization and provides an overall quality strategy to the leadership team.
- Leads the quality continuous improvement process, including monitoring and reporting the quality measures and KPIs/metrics and progress on achieving the quality objectives. Oversees the performance of periodic meetings to review all key performance indicators and trends.
- Develops and implements a regular lifecycle review of the facility design, qualification, and operation against the GMP requirements, including the GMP quality systems and tools.
- Develops programs for the audit and qualification of suppliers and vendors to ensure meeting the quality and GMP standards of AtomVie.
- Leads and implements a robust document management system (DMS), data integrity and retention policies, Quality risks management and governance program (QRG), and quality review and escalation process.
- Supports the regulatory team to successfully complete, submit, and respond to regulatory affairs and submittals requirements.
- Ensures planning budgeting, and execution of the Opex/Capex needs of the quality department.
- Develops and implements effective, robust quality management system (QMS) processes and methods in alignment with FDA, HC, EMA and other regulatory bodies requirements, through managing and controlling deviations, CAPAs, change controls, Product Quality Reviews (PQR), QC and Micro inspection programs, complaints management, and recalls management, internal audits.
- Develops and sets goals for Quality department, and follows up on progress through monitoring, identifying and addressing gaps and problems.
- New facility - staffing plans, overseeing facility commissioning, validation and qualification. Directing the delivery team, making sure that all regulatory and quality compliance requirements in the new facility are identified, planned and budgeted, and that all tasks are being executed as planned, including ensuring the new facility will be PAI ready as per the expected timelines.
- Develops and implements quality and compliance systems strategies and plans to enable AtomVie transition into commercial programs as a commercial manufacturing ready facility.
- Establishes and monitors quality agreements with clients. Ensures compliance with Health, Safety and Environment requirements.

**Experience Necessary**
- BSc. / MSc. / PhD. In a relevant scientific discipline
- Minimum of 15 years of pharmaceutical QA experience in an FDA/ Health Canada/ EMA regulated - industry is a must. Pharmaceutical biotech experience is an advantage.
- Minimum of 10 years' experience in Pharmaceutical QA management cross-functional teams including QC operat