Global Quality Senior Director, Clinical Quality

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

• Create an appropriate plan for conducting external health authority inspections and internal audits
• Provide quality and compliance oversight for all clinical development activities at POINT Biopharma and will perform a wide variety of activities ensuring Good Clinical Practice (GCP) compliance in accordance with applicable regulatory requirements
• Have an in-depth understanding and significant experience in GCP and compliance, leadership, communication skills, and business acumen to conduct responsibilities independently
• Collaborate with cross-functional teams to optimize clinical quality processes
• Ensure functional area management reviews are conducted; prepare appropriate metrics and present significant events to senior management
• Lead the global clinical quality team in establishing effective processes and providing guidance and support to clinical study teams
• Represent clinical quality expertise across the organization in GCLP and GCP
• Communicate the changing regulatory requirements, understand the impact of changes on other quality systems, and drive change
• Establish an inspection readiness program for Clinical
• Keep the organization updated with global health authority regulations and implement process improvements
• Provide strategic direction for the build-out and administration of Clinical Quality organization, in support of pipeline
• Ensure an appropriate and effective QMS for Clinical activities
• Direct, manage, and collaborate on the internal and external GCP audit program to assure adherence to relevant FDA, EMA, ICH and other global regulations, guidelines, and procedures
• Collaborate with Vendor Compliance to ensure GLP and GCLP external vendors, who provide materials and services on behalf of POINT, are appropriately approved prior to use

Objectives And Accountabilities

• Create and maintain a quality-focused culture and mindset across all staff within the organization
• Create and deploy short- and long-term objectives and strategies for responsible teams.
• Assess risks to the company and ensure they are monitored and minimized
• Manage (in-person or remotely) ongoing development programs including developing detailed technical work plans; selecting suitable service for the various activities; managing the performance of the vendors and preparing periodic updates for Sr. Mgmt. as may be required by internal governance demands
• Create and deploy short- and long-term objectives and strategies for responsible teams.
• Maintain required knowledge and compliance of applicable regulations and government, industry, and company GMP and GCP standards and their interpretations. Ensure new or changing regulations (FDA and foreign regulatory authorities) are implemented and GMP trends relevant to the radiopharmaceutical industry are identified, interpreted and communicated to all impacted staff
• Provide coaching, mentorship, education and feedback to individuals/ teams regarding quality and compliance expectations
• Serve as a key member in delivering the company’s product portfolio, including participation in the planning of timelines, deliverables, and milestones in collaboration with other cross-functional groups
• Foster the development of operational technology and data management systems in support of facility performance, asset management, and operational excellence
• Lead cross-functional efforts that manage third-party logistics production delivery and relationships for the project portfolio. Select third-party manufacturers working with Quality and Regulatory, negotiate effective technical agreements, and identify contract analytical laboratory sites through development to commercialization stages
• Develop and implement global quality standards and procedures to ensure the quality and reliability of products
• Ensure teams are compliant with all regulatory requirements, including cGMP, Quality policies and procedures, Environmental Health and Safety and Radiation Safety Programs, and Hazardous Material Handling and Disposal
• Develop and administer the Department budget and hiring plan in line with corporate goals and objectives
• This role works cross-functionally to develop strategies, set direction, plan, and prioritize initiatives that lead to the advancement of our project portfolio. This includes the: integration of the work priorities with other groups internal and external to the organization; Effective communication on such initiatives with senior leaders, peers, staff, and external stakeholders
• Measure and communicate team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s)
• Assess risks to the company and ensure they are monitored and minimized
• Create an environment that promotes great performance and positive morale
• Work cross-functionally to ensure the appropriate training and qualification program are in place for individuals supporting Clinical activities
• Support and lead quality improvement and Clinical compliance initiatives for the POINT
• Support regulatory inspections
• Create an environment that promotes great performance and positive morale
• Resource planning including budget and staffing model preparation (for departments, functions, or systems) and capacity monitoring of routine operations and enhancement projects
• Manage the development of QA staff, build-out of departmental leadership skill and identification of critical roles consistent with organizational growth and needs
• Champion development and maintenance of a Quality culture and mindset across the organization through continuous engagement, education, training, and leadership

Requirements

Education and Experience:

• Excellent critical thinking, problem-solving, and collaboration skills
• Familiarity with FDA and global clinical trial regulations (ICH, GCP)
• Strong communication skills, both written and verbal
• Ability to manage multiple priorities and work in a dynamic environment
• 10+ years managing a team of direct reports
• Proficiency in risk management principles
• Expertise in third-party and internal quality audits, issue management, and CAPA processes
• Proven leadership skills, ability to streamline operations, and execute daily tasks
• Strong understanding of quality management systems in clinical development
• Experience managing a team of QA professionals
• Bachelor's degree with 15+ years of experience in clinical development, preferably in clinical compliance or quality assurance

Competencies:

• Extensive knowledge and/or awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development
• Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Inspires respect and trust
• Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems
• Effective technical writing skills; able to write quality positions, audit reports, and procedures
• Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines with an appropriate sense of urgency
• Attention to detail and ability to analyze complex data

Benefits

• Retirement Plan (matching 401k)
• $100 cell phone reimbursement per month
• Eligible for annual incentive bonus plans and stock options
• Health Care Plan (Medical, Dental & Vision) – 85% paid by employer and effective day 1
• Voluntary Income Protection – Premiums paid by employee
• Income Protection Insurance – (Life AD&D, Short & Long-term disability) – 100% employer paid
• Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
• $500 fitness reimbursement per year

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.

POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

We do not accept unsolicited inquiries or resumes from agencies.