Quality Assurance Operations Support

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

The position of Quality Assurance Operations Support at POINT Biopharma is responsible for the following:

The Quality Assurance Representative Is Responsible for Demonstrating Leadership, Teamwork, And Quality and Regulatory Knowledge and Oversight to Provide Guidance, Consultation

Provides guidance and support to plant personnel to ensure training and documentation practices are executed in accordance with cGMP, ICH Guidelines and the FDA Code of Federal Regulations for aseptic drug products.

Provides guidance, expertise, and support during investigations, change controls, complaints and CAPAs within the eQMS.

The position is based in Indianapolis, Indiana, U.S. and directly reports to the Associate Director – Quality Assurance.

Objectives

• To participate in the successful establishment of a cGMP electronic Quality Management System (eQMS) which supports the site’s satisfactory Review during the PAI by FDA regulatory authorities. The eQMS will be utilized to manage controlled documents, employee training, deviation investigations, and Corrective and Preventative Actions (CAPA).
• To ensure all documentation practices at the manufacturing facility meet the defined requirements in accordance with the Quality Management System and cGMP practices.
• Escalating issues to management
• Review related batch records associated with parenteral manufacture, semi-finished devices, and final packaged product.
• Performs final batch disposition of raw materials, components, active pharmaceutical ingredient (API), semi-finished and/or finished drug product batches, to ensure high quality medicine (GMP Compliance) is released within expected metrics to ensure timely release to market.
• Participate in self-led inspections and/or provide support during internal/external regulatory inspections.
• Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls).
• Participates in Six Sigma project or process improvement initiatives to improve productivity within the Batch Disposition work center and/or the site.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Site Goals.

Accountabilities

• Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance
• Act as a cGMP liaison, working with Global Facility Delivery and POINT project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design
• Consult with quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase
• Actively participate in required design reviews and final design qualification activities

• Provide technical and quality review and approval of project documents to ensure compliance with POINT Quality Standards as well as project and local quality procedures
• Provide quality oversight for the verification and qualification of the manufacturing equipment and facilities, including review of test cases, test execution, discrepancy resolution, etc.
• Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross-functional support with focus on the Manufacturing areas
• Support the site organization in building technical capability, for a diverse cross-functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Support the definition and execution of inspection readiness activities including support of site self-inspections
• Lead project initiatives needed in support of the project and Quality function
• Resolve or escalate any compliance issues to the project, site, and Quality Management
• Provides guidance for deviations, observation handling; change control proposals; document creation and revisions.

Requirements

Education and Experience:

• Bachelor’s degree in a science field and/or relevant working experience.
• 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles
• An excellent understanding and knowledge of Microsoft office products – Word, Excel, and PowerPoint.
• Experience with electronic data systems is a plus.
• Experience creating and editing in multiple file systems.

Competencies

• Excellent oral and written communication skills
• Demonstrated ability to function well in a collaborative team environment
• Ability to plan, develop and execute multiple projects under tight timelines
• Operate and execute with an extreme sense of urgency
• Excellent organizational and interpersonal skills
• Demonstrated proficiency in Microsoft Office (including Outlook, Word, PowerPoint, Excel)
• Ability to collaborate with QA, CMC and regulatory colleagues to establish and justify release and stability specifications for starting materials, intermediates, drug substances and drug products
• Manage multiple projects, set priorities, and work in a fast-paced environment

Additional Information

Ability to work 8-12 hour shifts onsite

During the project phase, this position will allow for a flexible working environment with the ability to periodically work remotely based on the scope and nature of the activities

Why joining POINT today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:

• You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
• You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
• You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
• Most importantly, you will spend everyday working on something important

If what we are saying resonates with you, please submit a resume.

Benefits

• Health Care Plan (Medical, Dental & Vision) – 85% paid by employer and effective day 1
• Retirement Plan (matching 401k)
• Income Protection Insurance – (Life AD&D, Short & Long-term disability) – 100% employer paid
• Voluntary Income Protection – Premiums paid by employee
• Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
• $500 fitness reimbursement per year
• $50 cell phone reimbursement per paycheck ($1,300 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.