Job Description

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team. TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN CANADA. Location of work This position is located onsite downtown near University Avenue and College Street.
Overview Reporting to the Director of Quality Assurance & Quality Control, the Quality Assurance Manager will work across POINT\'s organization to support activities in clinical manufacturing, regulatory and general operations ensuring quality throughout the entire company. The Manager will ensures the Quality Management System and Vendor Management Program follows regulatory requirements.
Objectives

• Contribute to the achievement of the company\xe2\x80\x99s strategic goals by providing Quality Assurance oversight for all manufacturing operations activities.
• Maintain continuous readiness of the site for regulatory inspections.
• Contribute to maintenance and continuous improvement of compliance programs at the site.

Accountabilities

• Ensure all site activities, including production, testing, handling, and release of drug products are in compliance with external regulatory requirements.
• Assist in the development and maintenance of production and process controls to ensure compliance with cGMP regulations.
• Ensure all batch records and quality documents are reviewed and approved in a timely manner.
• Select, lead, and develop a quality team that manages the overall quality systems.
• Review and approve quality documents such as NC, Lab Investigation, CAPA, CC, specification, master batch records, protocols, reports, risk assessment, annual reports, environmental monitoring reports etc.
• Performs gap analysis through regular audits of Quality Management System and proposes plans to close gaps with the aim of continually improving QMS performance and maintain compliance with recognized industry standard.
• Monitor the training program to ensure all training are completed in a timely manner.
• Host client, regulatory and internal audits as required.
• Manages the vendor qualification program.
• Maintains current knowledge of regulations regarding products, validation and tech transfer and takes responsibility for training the QA team.
• Completes all other duties as required.

Requirements

• BS/BA - chemistry, Engineering, or similar scientific or technical field required.
• 7-10 years working in Quality Assurance position(s) supporting cGMP drug manufacturing.
• 3+ years managing a team of direct reports
• 5+ years of relevant work experience in Pharmaceutical, Biotech, Medical Device industry
• Experience managing QA department within a GMP pharmaceutical manufacturing environment.
• Experience participating in regulatory inspections (HC, FDA, ISO, etc) and responding to regulatory findings.
• Experience in setting up and managing vendor qualification program.
• Hands-on experience with authoring and managing quality documents and continuous process improvement.
• Ability to plan, develop and execute multiple projects under tight timelines.
• Operate and execute with an extreme sense of urgency.
• This role works in a hospital setting and it is mandatory for all employees to complete health screens before onboarding. In the event the screen results show non-immunity, vaccines may need to be administered.

Benefits

• Eligible for annual incentive bonus plan and stock options
• Healthcare plan (medical, dental, vision) \xe2\x80\x93 effective day 1
• Disability
• Life insurance
• RRSP matching plan

• Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
• $500 fitness reimbursement
• $50 cell phone reimbursement per month ($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.