Global Quality Vice President: QMS, SQM, & Compliance

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT’s active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location: Indianapolis, IN. Completed in Sept 2021, POINT's Indianapolis site is one of the largest state-of-the-art radiopharmaceutical manufacturing facilities in the world - almost as large as one and a half football fields.

Overview

The Quality Vice President of QMS, SQM, and Compliance is responsible for global aspects of implementing and managing effectiveness of the quality management systems, supplier quality management, and compliance across the company.

Position will be a member of the Global Sr Quality Leadership Team, influencing Quality standards and objectives for POINT.

Provide strategic direction for the build-out and administration of QMS, SQM, and Compliance programs across the organization, in support of regulatory, clinical, and manufacturing operations.

The position will lead the planning and implementation of new programs and initiatives in support of clinical and commercial manufacturing operations.

This role will provide direct leadership to QMS, SQM, and Compliance teams.

Lead a Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies.

The position is based in Indianapolis, Indiana, U.S. and directly reports to the Senior Vice President of Quality. The position will observe typical business hours, Monday through Friday. Some evening or weekend work may be required on an occasional basis.

Objectives

• Create and maintain a quality-focused culture and mindset across all staff within the organization.
• Responsible for the development and implementation of global quality standards and procedures to ensure the quality and reliability of products.
• Work across the network of POINT, ensuring that sites/locations are meeting applicable global standards and procedures, along with having the appropriate QMS.
• Develop and maintain a quality monitoring and metrics program for measuring the effectiveness of the QMS through an established set of KPIs.
• Support regulatory inspections.
• Ensure Quality Management System is in a constant and consistent state of compliance with cGMPs and in a state of inspection readiness.
• Oversight of the POINT Supplier Quality Management program ensuring compliance with applicable regulations.
• Global Quality Management of external vendors (service provider, suppliers) including determination of criticality, quality agreements, approved supplier lists, audit frequency, supplier change notification management, qualification requirements and SCAR process.
• Establish strategic succession planning for all areas within areas of responsibility.

Accountabilities

• Oversee the staff training program across the organization in accordance with GMP.
• Support and lead quality improvement and compliance initiatives for the POINT.
• Maintain required knowledge and compliance of applicable regulations and government, industry, and company GMP and GCP standards and their interpretations.
• Manage the development of QA staff, build-out of departmental leadership skill and identification of critical roles consistent with organizational growth and needs.
• Measure and communicate team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s).
• Foster a team ownership culture within the QA Department and across the manufacturing site that ensures compliance with all corporate policies, procedures, and regulations.
• Ensure new or changing regulations (FDA and foreign regulatory authorities) are implemented and GMP trends relevant to the radiopharmaceutical industry are identified, interpreted and communicated to all impacted staff.
• Provide coaching, mentorship, education and feedback to individuals/ teams regarding quality and compliance expectations.
• Develop and administer the Department budget and hiring plan