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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. POINTs active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein- (FAP-), 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 Supplier Quality Specialist is responsible for executing all aspects of the supplier assessment process for the Supplier Management Program (SQM). Coordinating requests for new suppliers which include Questionnaires, Quality Agreements, Specifications.

Perform actions associated with Change Management and Corrective and Preventative Actions (CAPAs). Manage and update the supplier record, including Supplier Corrective Action Request (SCARs) and Supplier Initiated Change Notification (SICNs) and supporting Supplier Quality projects as needed.

The Supplier Quality Specialist will work across the POINT organization to support activities associated with internal/external auditing, Key Performance Indicator (KPI) tracking, and Quality Management Review as it relates to the SQM program.

The position is based in Indianapolis, Indiana, U.S. and directly reports to the Global Quality Director of Supplier Quality Management & Auditing.

Objectives

Contribute to the achievement of the companys strategic goals by providing front line support for the SQM program for all cGMP raw materials, consumables, services, and equipment.
Ensure that the SQM process remains compliant with cGMP as defined within FDA CFR 21, part 210 and 211, associated regulatory guidance documents, and ICH and USP relevant chapters for pharmaceutical products.
Support Global Product Quality GxP Audit Lead to ensure that all required external audits are planned and scheduled.
Leads and conducts qualification, routine, for-cause audits of suppliers / service providers to ensure compliance with Global and Local Otsuka, and applicable regulatory requirements.
Author Standard Operating Procedures, work instructions, forms, templates and other documents associated with the audit process as needed and for periodic review.
Assists in the development of training programs for inspection readiness and improvements with Internal Audit and Supplier Quality Programs along with other Quality Systems.
Participates in Inspection Readiness activities and supports Regulatory Inspections.
Coordinate with cross functional teams for periodic review of Quality Agreements.

Successfully executes the following critical business functions in support of Quality and Compliance:
Manage new suppliers, Audit Schedule, and the Approved Supplier List (ASL) for the Indianapolis site.
Coordinate and tracks SCARs though closure with the supplier, service, or equipment provider.
Work with key stakeholders to review and approve SICNs.
Schedule and perform internal/ SQM audits as needed.
Maintain QMS administration activities for SQM.
Support KPI tracking and trending.
Provide data and metrics for Quality Management Reviews.
Lead non-conformance investigations and corrective actions associated with SQM.
Develop and/or update Standard Operating Procedures (SOPs) and Forms to ensure adherence to cGMPs.

Accountabilities

Collaborate efficiently with key stakeholders for the supplier, service, or equipment provider on the approval process
Is responsible for maintaining the Approved Supplier List in an inspection ready state.
Provides guidance and leadership around SCARs, ensuring communication to the supplier, service or equipment provider and are tracked to closure in a timely manner.
Ensures Supplier Change Notifications are evaluated documented and evaluated based on risk to patient and product.
Drive continuous improvement of the core SQM program to ensure efficiency and compliance with EU, ISO, CFR and POINT Policies and Procedures.
Provide additional support to site quality team members as needed.

Requirements

Education and Experience:

BA/BS degree is required
Life-sciences, Engineering, or Technical degree is an asset
5-8 years working in Quality Assurance position(s) supporting cGMP drug manufacturing
4+ years of relevant work experience in Pharmaceutical, Biotech, Medical Device industry
Supplier Management and/or Audit experience and/or certification is a plus

Critical Competencies:

Experience participating in regulatory inspections (FDA, EU, ISO, etc.) pertaining to Quality Management Systems.
Hands-on experience with authoring and approving quality documentation (SOPs, Training Records, Audit Agendas, Audit Reports, Key Process Indicator Reports).
Ability to plan, develop and execute multiple projects under tight timelines.
Operate and execute with an extreme sense of urgency.
Availability to participate in remote and onsite audits (10-15% total time, including travel as needed).

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.

POINT Biopharma

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