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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. POINTs active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein- (FAP-), 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 POINTs 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 POINTs 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 operates and updates corporate IT policies, guidelines, etc to assure compliance.
Provides mentoring to teams and individuals to ensure compliance with regulations and POINT policies and standards for employees, contractors and managed service providers for GxP related systems.
Communicates with and trains IT employees, contractors and manages service providers on quality awareness and compliance process improvements.
Manages the impact of 21 CFR Part 11 on POINTs computer systems, including Quality Management Systems
Collaborates with various business areas to assess DI maturity state and provide DI guidance and best practices.

Requirements

At least 8+ years of IT related work experience.
Minimum of 5 years related work experience with quality assurance and testing life cycle activities and deliverables.
Minimum of 2 years work experience with pharmaceutical regulatory compliance and global regulations for computerized systems validation.
Education and Experience
Minimum bachelors degree (Computer Science preferred) or equivalent work experience.
Knowledge of Good Clinical Practices (GCPs), Good Manufacturing Practices (GMP); FDA regulations (21 CFR Part 11; Part 210; Part 211, Part 820), EU GMP Annex 11: Computerized Systems, ISPE GAMP and Computer Systems Validation Life Cycle.
Experience in managing application / system changes in accordance with GxP regulations.
Proven experience in test management; has an excellent understanding of the role of software testing and of all testing events to support varied projects / programs including in-house development, third party applications, infrastructure projects, migration and integration projects

Why joining POINT today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself and we strongly believe POINT is the right career move for you. Here is why:

You will help establish and define an organization that will change the course of cancer therapies and help thousands of people each year
You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
Most importantly, you will spend everyday working on something important
If what we are saying resonates with you, please submit a resume.

Benefits

Health Care Plan (Medical, Dental & Vision) 85% paid by employer and effective day 1
Retirement Plan (matching 401k)
Income Protection Insurance (Life AD&D, Short & Long-term disability) 100% employer paid
Voluntary Income Protection Premiums paid by employee
Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
$500 fitness reimbursement per year
$50 cell phone reimbursement per paycheck ($1,300 per year)

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

We do not accept unsolicited inquiries or resumes from agencies.

POINT Biopharma

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