Global Quality Director- Auditing

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 Senior Vice President of Quality, the Global Quality Director of Audits will be responsible for:

• Lead annual global audit planning activities, including risk evaluation, to drive regulatory compliance and quality across GxPs.
• Leads the development and execution of POINT’s annual supplier and corporate audit programs.
• Oversee the implementation, maintenance and continuous improvement of audit enabling processes across the GxP enterprise.
• Ensure auditing framework processes are established, implemented, and continuously improved.
• Work directly with the SQM organization to support the development and maintenance of audit frequency for suppliers and services providers based upon risk management.
• Ensure individuals conducting audits have the appropriate documented qualifications and required certifications to conduct audits.
• Ensuring POINT Quality Systems adhere to relevant FDA, HC, EMA, and ICH and other global regulations, guidelines, and procedures.

Objectives

• Identify opportunities for improvements against corporate policies, local procedures, industry standards and laws/regulations.
• Serve as a Lead Auditor for risk-based internal and external audits, assuring site compliance to regulations and procedures.
• Ability to host and/or support audits and regulatory inspections.
• Facilitate and take accountability for ongoing improvements of the internal audit process.
• Analyze audit data through metrics and trending.
• Provide documented findings and recommendations in audit reports.
• Present audit findings to senior management.
• Continuously improve the auditing program requirements, along with site self-inspection requirements to ensure the organization’s manufacturing operations, infrastructure, staff, practices, systems, and policies meet internal requirements and regulatory expectations.
• Establish departmental goals, KPIs, strategic initiatives, and priorities for the audit team.
• 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 team.

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.
• Ensure compliance of staff training program across the site in accordance with GMP, including periodic review, and internal audits of operator training.
• Support quality improvement and compliance
• Assess quality metrics and perform effectiveness checks for quality process improvements.
• Maintain required knowledge and compliance of applicable regu