Job Description

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 but is not limited to: 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-2068, a bispecific IgG-based EGFR-cMET targeted radioconjugate currently in a Phase 1 trial. Fusion has multiple other pipeline programs that will soon be entering into early FIH trials. In addition, Fusion is pursuing combination programs between RCs and other therapeutic modalities including DNA Damage Response Inhibitors (DDRis) and immune-oncology agents. To support execution for these programs, Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radioconjugate manufacturing facility to meet supply demand for our growing pipeline of RCs.



Position Summary:


Associate Director, Site Operations Quality Systems leads all quality-control, microbiology and release related operations to ensure that products meet stringent quality and regulatory standards. This role involves managing a team, providing technical oversight, setting strategy, overseeing testing, and ensuring compliance within a Good Manufacturing Practices (GMP) environment, most commonly in the pharmaceutical, biotechnology, or medical device industries. The AD, Technical Services is responsible for Quality Control activities including biochemistry, microbiology, environmental monitoring, raw materials, stability, method transfer, instrument and software qualification, data integrity, sample management, and QC document management.


Role will be responsible for championing operational excellence and innovation as well QC targets, to ensure stable planning of QC activities as per site needs. Responsible for people development and growth. Creates a culture in the QC organization that leads to employee satisfaction and retention. Contributes to the site's growth strategy, including planning, and safety.


Requirements:

Partners with the Head of Radiopharmaceutical Quality, Global Site Leadership and Quality Operations functions in executing the strategic goals of the company Lead the Quality Control Department with responsibility for the following groups within the department: Raw Material, Analytical, Biochemistry, Microbiology, Environmental Monitoring, Assay validation/transfer, laboratory information and sample logistics and includes all personnel associated with the department i.e. FTE, interns and contractors Develops and executes the QC strategy for the site. Ensures quality and delivery meets or exceeds internal stakeholder and customer expectations Oversees raw materials testing, in-process and finished product testing, environmental monitoring and microbiology, stability testing, method transfer and validation, instrument and software qualification, QC data integrity, sample management, and QC document management Drives continuous improvement initiatives to ensure that the QC organization meets key performance indicator goals To evaluate and prioritize QC projects in the medium and long term, ensuring that the human, technical and financial resources are focused on the achievement of strategic objectives Works closely with Program Management, Quality Assurance, Manufacturing to support project teams throughout the product lifecycle Attends Site Management Review and other meetings as needed, e.g. Change Control Committee, Deviation Review Board, CAPA Board Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance in resolving issues Builds and maintains expertise in the QC organization, ensuring that the QC organization supports site operations through ongoing development of staff Represents QC function in Joint Steering Committee meetings with vendors Supports Regulatory, Batch Release and Internal Audits as needed To approve or reject starting materials, packaging materials, intermediate, bulk and finished products Responsible to ensure the QC operations comply to cGMP and safety regulations Responsible to ensure QC participation in the multidisciplinary teams and global QC work teams To lead the development and implementation of improvement systems in the area in line with the Operational Excellence strategy Ensure escalation of non-compliance or ineffective Quality System deployment at site Plan resources for QC to support projects and testing in alignment with production activities. To ensure that all necessary testing is carried out and the associated records evaluated To lead the method transfer activities for customer projects in Quality Control To lead from a QC standpoint audits/inspections by customers and/or regulatory agencies To ensure the development and coaching of QC staff to improve their performance, abilities and competences Drive the timely release of test results and approval of certificate of Analysis to support batch release Ensure that product has been manufactured and tested in accordance with cGMP requirements, company SOPs, policies and specifications To approve specifications, sampling instructions, test methods and other Quality Control procedures. To ensure the qualification and maintenance of QC premises / equipment and appropriate validations are done Apply Data Integrity principles in all aspects of work, in compliance with Lonza DI policies, guidelines and procedures Any other duties as assigned by Head of Radiopharmaceutical Quality


Qualifications:

Bachelor's degree in Life Sciences is preferred; a combination of education and years of experience will be considered with 10+ years of QC experience Leadership skills- ability to coach, manage and lead diverse teams Demonstrated ability to present ideas publicly to inform, educate and influence others positively in achieving business results Excellent communications skills both written and verbal format Relate to others in a team setting. Active listener seeking to understand and to be understood. Able to coach and manage experienced and inexperienced staff Maintain positive attitude and emotional composure in a team environment Maintain control of meetings with direct reports Mentoring and leading direct reports Being able to deliver difficult messages to staff (i.e. disciplinary actions, poor performance plans) Deep familiarity with global regulatory requirements, including FDA, Health Canada, MHRA, EMA, and ICH guidelines. Proficiency with testing techniques, environmental monitoring, method validation, and laboratory information management systems (LIMS).


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.