Quality Assurance Operations Support

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 position of Quality Assurance Operations Support at POINT Biopharma is responsible for the following:

The Quality Assurance Representative Is Responsible for Demonstrating Leadership, Teamwork, And Quality and Regulatory Knowledge and Oversight to Provide Guidance, Consultation

Provides guidance and support to plant personnel to ensure training and documentation practices are executed in accordance with cGMP, ICH Guidelines and the FDA Code of Federal Regulations for aseptic drug products.

Provides guidance, expertise, and support during investigations, change controls, complaints and CAPAs within the eQMS.

The position is based in Indianapolis, Indiana, U.S. and directly reports to the Associate Director – Quality Assurance.

Objectives

• To participate in the successful establishment of a cGMP electronic Quality Management System (eQMS) which supports the site’s satisfactory Review during the PAI by FDA regulatory authorities. The eQMS will be utilized to manage controlled documents, employee training, deviation investigations, and Corrective and Preventative Actions (CAPA).
• To ensure all documentation practices at the manufacturing facility meet the defined requirements in accordance with the Quality Management System and cGMP practices.
• Escalating issues to management
• Review related batch records associated with parenteral manufacture, semi-finished devices, and final packaged product.
• Performs final batch disposition of raw materials, components, active pharmaceutical ingredient (API), semi-finished and/or finished drug product batches, to ensure high quality medicine (GMP Compliance) is released within expected metrics to ensure timely release to market.
• Participate in self-led inspections and/or provide support during internal/external regulatory inspections.
• Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls).
• Participates in Six Sigma project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Site Goals.

Accountabilities

• Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
• Act as a cGMP liaison, working with Global Facility Delivery and POINT project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design
• Consult with quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase
• Actively participate in required design reviews and final design qualification activities

• Provide technical and quality review and approval of project documents to ensure compliance with POINT Quality Standards as well as project and local quality procedures
• Provide quality oversight for the verification and qualification of the manufacturing equipment and facilities, including review of test cases, test execution, discrepancy resolution, etc.
• Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areas
• Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other