Associate Director, Quality Assurance

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 – Quality Assurance, reporting to the Sr Director of QA/QC, is responsible for managing the activities of Quality Assurance personnel.

The Associate Director Quality Assurance must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations.

The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation.

The position requires working cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.

Objectives

• Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, 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 technical agenda, site business plan objectives, and GMP Quality Plan objectives
• Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
• Define strategic direction and provide oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio.
• Ensure adequate oversight and technical excellence for investigations and complaints.
• Ensure adequate oversight for technical projects to improve process control, capacity, yield, quality

• Ensure adequate technical representation and engagement within site and network governance meetings to influence technical agendas.
• Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
• Potential to engage and influence Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.
• Escalate issues to management.

Accountabilities

• Batch record review (Executed and Master) for all stages of manufacturing
• Promote a positive Quality Culture and oversee on-the-floor Quality presence in the respective business area (e.g., manufacturing).
• Provide Quality direction for complex business and operational issues or technical challenges. Remove barriers as they arise.
• Final disposition of finished product for commercial and clinical use, including country-specific release and collaboration with Qualified Persons (QPs)
• Authoring and review of deviations, CAPAs, and change controls
• Investigation of product complaints

• Quality review of analytical documentation including: analytical methods; validation protocols and reports; specifications; and stability protocols, reports, and expiry extensions
• Oversee and monitor Quality metrics. Ensure data compiled are communicated in relevant forums and escalate compliance issues/concerns to Quality senior management.
• Review and approval of commercial and clinical product labels
• Authoring/ revision of SOPs
• Leading process improvements
• Ensuring that GMP work at POINT and contract organizations is done in compliance with applicable laws, regulations, guidelines, and SOPs.
• Participation on project teams and sub-teams as needed and assigned
• Compose and review SOPs, protocols, reports, forms, and certificates of analysis.
• Interact with auditors and regulatory inspectors.
• Collaborate with other departments on projects, including inter-site a