Senior Associate, Quality Operations

at  Fusion Pharmaceuticals US Inc

Fusion Pharmaceuticals (NASDAQ: FUSN) is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals 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 prostate specific membrane antigen (PSMA) for metastatic castration resistant prostate cancer currently in a Phase 2 trial; FPI-1434 targeting insulin-like growth factor 1 receptor currently in a Phase 1 trial; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1), currently in a Phase 1 trial. In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion’s TATs and AstraZeneca’s DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck’s KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. To support Fusion’s growing pipeline of TATs, the company has signed strategic actinium supply agreements with TRIUMF, Niowave, and BWXT Medical.

POSITION SUMMARY:

The Senior Associate, Quality Operations provides technical expertise, guidance of the Fusion manufacturing facility, and support to the manufacturing operations team from clinical development stages through global commercialization. This role ensures compliance to applicable regulatory requirements and procedures, while delivering to the objectives of applicable programs and strategic objectives, in alignment with both the Quality Department and Supply Chain. This role will report directly to the Director, Site Quality.

MINIMAL QUALIFICATIONS:

• Bachelor’s degree with 3-5 years of experience in a regulated industry.
• Must be on-site (Hamilton, ON) for Quality support of ongoing activities.

• Knowledge of quality operations and compliance of clinical and commercial manufacturing.

  Prior radiopharmaceuticals experience is a plus.

• Excellent interpersonal skills, including team-oriented approach with ability to partner with others in fast paced, rapidly changing environment.

• Experience in the review and auditing of executed batch records, material release records, and qualification protocols.
• Must possess excellent written, organizational and communication skills.

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

• Partner with other quality functions, manufacturing teams, regulatory, vendors, suppliers, and facilities, to provide input review, and approval of key executed documents, including, but not limited to: MBR/specifications, change control documents, Deviations, investigations, CAPAs, Deviations, Laboratory methods and validation reports, Testing specifications, Analytical results - Stability reports - Non-conformance reports.
• Provide QA support for ongoing validation activities for equipment, facility, utility, laboratory, cleaning, sterilization, and process qualification and validation. Review and approval of method validation, process validation, and tech transfer (as required).
• Performs disposition of raw materials, as required.
• Conduct internal audits for GMP compliance including plan development, execution, and report. Participate in and support regulatory audits.
• Participate in the development of risk management control processes.
• Support the development of procedures related to GMP compliance, quality management systems, document management and control, annual product reviews, training, and raw material/product disposition.
• Remain current with industry trends and methodologies relevant to GxP process and programs.
• As needed, support global quality, research & development, as well as discovery goals.