Senior Director, Quality Assurance and Quality Control

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 the Global Quality Vice President of QMS, and SQM, the Indianapolis Senior Director of Quality Assurance and Quality Control will be responsible for the following:

• Leading all Quality Assurance and Quality Control functions related to Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
• Overseeing the build-out and administration of all aspects of the Quality Assurance Program across the organization, in support of regulatory, clinical, and manufacturing operations.
• Overseeing Quality Control functions, including microbiology, sterility assurance, environmental monitoring, routine QC testing activities, and the analytical laboratories necessary to support these activities.
• Ensuring compliance with employee training program across the entire site.
• Providing Quality and compliance oversight for clinical development activities and ensuring Good Clinical Practice (GCP) compliance in accordance with applicable regulatory requirements.
• Ensuring Quality Systems adhere to relevant FDA, HC, EMA, and ICH and other global regulations, guidelines, and procedures.

Objectives

• Establish departmental goals, KPIs, strategic initiatives, and priorities for the Quality Assurance and Quality Control teams.
• Develop and manage a Quality Assurance program to ensure the organization’s manufacturing operations, infrastructure, staff, practices, systems, and policies meet internal requirements and regulatory expectations.
• Ensure analytical development and QC activities are in alignment with manufacturing operations to ensure products progress through their lifecycles on time and on budget.
• Champion development and maintenance of a Quality culture and mindset across the organization through continuous engagement, education, training, and leadership.
• Establish strategic succession planning for all areas within the QA/QC function.

Accountabilities

• Ensure products are tested in accordance with cGMP and meet quality release specifications.
• Ensure analytical and microbiology laboratories, compendial test methods, and routine operations are established and suitable to support GMP product testing.
• Oversee environmental monitoring program, including establishment of microbial identification, facility-specific flora database, microbial and non-viable alert limits, investigations, and data trending, analysis and associated CAPAs.
• Oversee sterility assurance program, including operator, process and facility qualification, operator aseptic training, and establishment of facility aseptic controls.
• Oversee 21 CFR Part 11 compliance pertaining to electronic records and computer system validation.
• Establish key performance indicators for the quality management system and quality operations.
• Identify and execute continuous engagement, education, and training initiatives to strengthen and maintain a quality culture and mindset across the organization.
• Overall accountability for facility and organizational compliance with regulatory bodies, including audits and inspections.
• Develop and administer quality assurance and quality control budget.
• Ensure compliance of staff training program across the site in accordance with GMP, including periodic review, and internal audits of operator training.
• Set quality improvement and compliance initiatives for the quality assurance and quality control teams.
• Assess quality metrics and perform effectiveness checks for quality process improvements.
• Maintain required knowledge and compliance of applicable regulations and government, industry, and company GMP and GCP standards and