Quality IT Systems Specialist

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 CQV, Quality IT Systems Specialist is responsible for all computerized systems and infrastructure utilized in the manufacturing of drug products at POINT’s Indianapolis campus.

The Quality IT Systems Specialist is responsible to help ensure POINT is choosing, deploying and supporting computing platforms and solutions in compliance with applicable global regulations and in accordance with POINT standards and senior management intentions. Through an IT Quality Assurance framework, the role is to provide assurance to POINT management that the controls they have implemented are being executed.

The Quality IT Systems Specialist is responsible for monitoring and auditing 21CFRPart11 Compliance of Computer Systems used by POINT to attain, maintain, and demonstrate compliance and information security excellence. The Quality IT Systems Specialist is responsible for ensuring electronic records and signatures are in conformance with the requirements of 21 CFR Part 11 compliance

The Specialist is responsible for supporting quality awareness efforts to ensure quality principles are disseminated throughout the IT organization and affected user communities.

Objectives

• Provide expertise and/or training in system qualification, application validation, and 21 CFR Part 11/210/211/820, and Annex 11 DI guidance, and regulatory compliance governing the pharma industry to POINT.
• Supports project teams to create, update and maintain SDLC (Software Development Life Cycle) standards, guidelines, and procedures used for GxP systems.
• Creates and updates as assigned corrective and preventative action (CAPA) processes, procedures and systems for GxP Systems as assigned.
• Creates and updates as assigned deviation management processes (including investigations and root cause analysis) and procedures for GxP systems as assigned.
• Creates and updates as assigned change control management processes and procedures for GxP systems as assigned.
• Responsible as assigned for validation strategies and validation planning for new, modified or retired GxP IT systems.
• Reviews and approves as assigned documentation of SOPS, SDLC tasks, and other ITQA processes for use in supporting compliance with GxP regulations and guidance.
• Supports and maintains as assigned a repository of controlled documents related to GxP IT QA Systems.
• Evaluates POINT’s use and documentation of electronic records and signatures as governed by regulatory requirements.
• Promotes the concept of quality, the principles of quality management and devises and implements quality improvements within QA IT.

Accountabilities

• Responsible as assigned for GxP auditing for internal and external computing platforms and solutions to ensure 21CFR Part 11 compliance.
• Conducts audits and periodic review as assigned for quality assurance compliance with regulations and POINT IT policies and standards for internally deployed IT systems.
• Performs data integrity assessments, deviation investigations, and supports/performs data integrity remediations in cGMP operations.

• Collaborates with IT Security and QA groups as assigned to conduct external audits and periodic reviews for compliance with information governance and cyber security regulations and POINT policies for GxP cloud-based solutions, hosted systems and external suppliers and partners.
• Supports management to engage with regulatory agencies as assigned on GxP related IT topics.
• Serves as the QA IT contact for all aspects of internal audits, inspections, and regulatory agencies.
• Supports as assigned the process to monitor IT regulations issued by each country where POINT business ope