Global Quality Director- Supplier Quality Management (SQM)

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

Reporting to the Global Quality Vice President of QMS, SQM, and Compliance, the Global Quality Director of SQM will be responsible for:

• Lead annual global SQM planning activities, including risk evaluation, to drive regulatory compliance and quality across GxPs.
• Lead the development and execution of POINT’s annual supplier risk assessment program.
• Ensure SQM framework processes are established, implemented, and continuously improved.
• Oversee the implementation, maintenance and continuous improvement of SQM processes across the GxP enterprise.
• Work directly with the auditing organization to support the development and maintenance of audit frequency for suppliers and services providers based upon risk management.
• Work across the network to ensure the appropriate controls are in place for receiving materials from suppliers.
• Ensure direct reports have the appropriate documented qualifications for supporting the business.
• Ensure POINT Quality Systems adhere to relevant FDA, HC, EMA, and ICH and other global regulations, guidelines, and procedures.

Objectives

• Identify opportunities for improvements against corporate policies, local procedures, industry standards and laws/regulations.
• Support auditing team as an Auditor for risk-based internal and external audits, assuring site compliance to regulations and procedures.
• Ability to support audits and regulatory inspections as an SME for SQM.
• Analyze data through metrics and trending.
• Establish governance program for assessing associated risk for suppliers.
• Present key SQM risks to senior management.
• Continuously improve the SQM program requirements to ensure the organization’s manufacturing operations, infrastructure, staff, practices, systems, and policies meet internal requirements and regulatory expectations.
• Establish departmental goals, KPIs, strategic initiatives, and priorities for the audit team.
• Champion development and maintenance of a Quality culture and mindset across the organization through continuous engagement, education, training, and leadership.
• Establish strategic succession planning for team.

Accountabilities

• Identify and execute continuous engagement, education, and training initiatives to strengthen and maintain a quality culture and mindset across the organization.
• Assess quality metrics and perform effectiveness checks for quality process improvements.
• Maintain required knowledge and compliance of applicable regulations and government, industry, and company GMP and GCP standards and their interpretations.
• Provide supplier quality oversight of material suppliers (e.g., media, chemicals & excipients, single use systems, primary & secondary packaging component, device) under a centralized SQM function.
• Manage suppliers holistically by utilizing internal (e.g., deviation trends, OOS) and external signals (e.g., regulatory intelligence, external audits)
• Manage supplier change notifications or vendor-initiated changes.
• Manage supplier investigations and corrective actions.
• Manage completion of audit observation responses in a timely and effective manner
• Align and negotiate Quality Agreement terms with internal stakeholders and external partners.
• Deploy quality risk management principles to ensure appropriate risk mitigation and control is exercised at the commodity/material level when approving supplier corrective actions.
• Monitor and measure the effectiveness of suppliers and provide periodic updates to Senior Leadership
• Develop and implement processes for supplier management and mat