Supplier Quality Lead

Fusion Pharmaceuticals; Hamilton; On-site; CAD 90,000 - 120,000; Full time

Job summary

A clinical-stage oncology company is seeking a Supplier Quality Lead to oversee quality assurance processes related to suppliers, ensuring compliance with quality standards. This role requires developing strategies, conducting audits, and managing supplier relationships. Ideal candidates should have extensive experience in supplier quality management, preferably in the Biotech sector, and hold a relevant degree. The position is based in Hamilton, Ontario, and offers a collaborative work environment.

Qualifications

• Minimum of 10-12 years of experience in supplier quality management.
• Prior experience with radiopharmaceuticals is desired.
• Phase 1 / Phase 2 supplier quality management experience in a Biotech / Pharma setting desired.

Responsibilities

• Develop and implement a comprehensive supplier quality strategy aligned with organizational goals.
• Evaluate and select suppliers based on quality performance, capabilities, and risk assessments.
• Oversee supplier audits and assessments, ensuring adherence to quality standards and regulations.

Skills

Analytical skills

Problem-solving skills

Communication skills

Interpersonal skills

Education

Bachelor’s degree in Engineering, Quality Assurance, Supply Chain Management

Master’s degree

Tools

Quality management software

Data analysis tools

Job description

Overview

Join to apply for the Supplier Quality Lead role at Fusion Pharmaceuticals

Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules to selectively deliver the alpha emitting payloads to tumors. Fusion’s clinical portfolio includes: FPI-2265 targeting PSMA for metastatic castration resistant prostate cancer in a Phase 2 trial; FPI-1434 targeting IGF-1R in Phase 1; FPI-2059 targeting neurotensin receptor 1 (NTSR1) in Phase 1; and FPI-2068, an EGFR-cMET radioconjugate in Phase 1. Fusion is pursuing combination programs between RCs and DDR inhibitors and immune-oncology agents. Fusion has a GMP compliant radiopharmaceutical manufacturing facility to meet supply demand for its pipeline.

Summary Of The Position

The Supplier Quality Lead oversees the quality assurance processes related to suppliers and ensures all products meet the company’s quality standards. This role involves developing supplier quality strategies, conducting audits, managing supplier relationships, and collaborating with cross-functional teams to drive continuous improvement. The role partners with business stakeholders to identify and mitigate risks, align with regulatory and commercial strategy, and support Fusion’s clinical development pipeline. The Supplier Quality Lead will report to the Vice President, Quality and will be based in Hamilton, Ontario or Boston, Massachusetts.

Responsibilities

• Develop and implement a comprehensive supplier quality strategy aligned with organizational goals
• Evaluate and select suppliers based on quality performance, capabilities, and risk assessments
• Establish and maintain strong relationships with key suppliers to drive quality improvements
• Oversee supplier audits and assessments, ensuring adherence to quality standards and regulations
• Develop and implement quality metrics to monitor supplier performance
• Collaborate with suppliers and internal teams to identify areas for quality improvement
• Drive initiatives such as root cause analysis and corrective action plans for quality issues
• Work closely with procurement, engineering, and manufacturing teams to align supplier quality goals with operational needs
• Facilitate training and knowledge sharing regarding quality standards and processes
• Prepare quality reports for senior management, highlighting trends and areas of concern

Qualifications

• Bachelor’s degree in Engineering, Quality Assurance, Supply Chain Management, or a related field; Master’s degree preferred
• Minimum of 10-12 years of experience in supplier quality management
• Prior experience with radiopharmaceuticals is desired
• Phase 1 / Phase 2 supplier quality management experience in a Biotech / Pharma setting desired
• Strong knowledge of quality management systems (e.g., ICH Q10) and quality tools (e.g., Six Sigma, Lean)
• Excellent analytical, problem-solving, and decision-making skills
• Strong communication and interpersonal skills, with the ability to work collaboratively across functions
• Demonstrated ability to effectively lead professional staff and teams
• Familiarity with supplier risk management and assessment methodologies
• Proficiency in quality management software and data analysis tools
• Approximately 20-30% business travel required to external CDMO / Business Partner sites, or to attend professional development training seminars – as needed / directed

Fusion Pharmaceuticals is an equal opportunity employer that is committed to inclusive, barrier-free recruitment and selection processes. If contacted for an interview, please advise Human Resources if you require accommodation.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Quality Assurance

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