Associate Director, Quality Systems

Overview

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.

The Associate Director of Quality Systems is responsible for overseeing the continued development, improvement, execution, and oversight of the Quality Management System (QMS) to ensure compliance with all EU, ISO, and FDA standards.

The Associate Director of Quality Systems will work across the POINT organization to lead day-to-day activities in document control, training, Key Performance Indicator (KPI) tracking and trending, and quality management review while remaining current in regulatory expectations for Quality Management Systems.

The position is based on-site in Indianapolis, Indiana, U.S. and directly reports to the Vice President, Quality Operations and QMS

Objectives

• Contribute to the achievement of the company’s strategic goals by providing oversight for all Quality Management Systems and leading a team consisting of QA Specialists, QA Administrators, and Training Coordinators.
• Ensure technical review and approval for documents, including deviation/complaint investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, personnel qualification strategies, control strategies, technical studies, etc.
• Performance management and development of staff.
• Partner within Quality Assurance and across functional disciplines to influence and implement the site business plan and GMP Quality Plan objectives
• Interact with regulators and other external stakeholders on business issues and continuous improvement activities.
• Define strategic direction of the Quality Management System
• Network internally and externally to share best practices, rationale, and control strategies to continuously improve local systems and business processes.

• Ensure that the Quality Management System remains compliant with cGMP as defined within FDA CFR 21, part 210 and 211, EU Annex 1, ICH and USP relevant chapters for pharmaceutical products.
• Select, lead, and develop a team that successfully executes the following critical business functions in support of Quality and Compliance:
• Employee training

• Document control

• Electronic QMS administration

• KPI tracking and trending

• Quality management review

• Electronic and hard copy data management

• Data integrity program

Accountabilities

• Collaborate with and provide functional leadership and support to the broader Quality Assurance team.
• Contribute to the development, maintenance, and continuous improvement of the POINT QMS, including Change and Deviation Management
• Ensure that production, testing, handling, and release of drug products are in compliance with documented procedures and specifications as well as external regulatory requirements.

Requirements

Education and Experience:

• Bachelor’s Degree in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or related field
• 7+ years of experience in Quality Assurance in a pharmaceutical manufacturing environment.

Critical Competencies:

• Experience managing Quality Assurance within a GMP pharmaceutical manufacturing environment
• Experience in regulatory inspections (FDA, EU, ISO, etc) pertaining to Quality Management Systems
• Hands-on experience with authoring and approving quality documentation (SOPs, Training Records, Audit Agendas, Audit Reports, Key Process Indicator Reports, Annual Product Reviews, Deviation/Change Management)
• Ability to plan, develop and execute multiple projects under tight timelines.
• Excellent communication skills, including preparation of technical and executive summarie