Title | Quality Project Manager

Location | Van Nuys, CA

Department | Quality & Compliance

Reports To | Director, QM

SOFIE is committed to all aspects of Quality and Compliance in the manufacture of Radiopharmaceutical products. SOFIE aseptically manufactures therapeutic and diagnostic radiopharmaceuticals across the US

The Quality Project Manager will manage high-criticality projects to support the long-term goals of the business. The Quality Project Manager will design and execute validations, qualifications, project plans, and will be tasked with supporting and managing Quality initiatives across the United States. The candidate must be strong at project management, technical and quality writing, root cause analysis, executing tasks to completion, electronic systems, and MS Office Applications

• Plan and manage the execution of complex quality, verification/validation, and regulatory projects.
• Responsible for directly and indirectly leading cross-functional teams in the execution of project plans
• Build team ownership and commitment to project and business plans and define project milestones and resource requirements.
• Conduct routine meetings to ensure accountability and milestone achievements with team(s)
• Sets prioritization of team member activities and follow up on actions.
• Actively seeks collaboration and builds relationships with internal and external parties to improve overall outcomes and timely project completion.
• Manages and serves as the subject matter expert on the project team regarding validation/verification requirements, regulatory requirements and technical capabilities of the equipment/infrastructure to be deployed.
• Design, review, and execute validations and qualifications of equipment, facilities, processes, and infrastructure
• Proactively identify and assess areas of risk, escalate issues in a timely manner and proactively propose solutions.
• Implement and manage project changes and interventions to achieve timely project outputs.
• Provide regular project updates (written and verbal) to appropriate management.
• Serves on project steering committees.
• Develop a team culture of continuous improvement and teamwork that strives to improve in quality, safety, delivery and cost
• Responsible for opening change controls and initiating, maintaining, and reviewing SOFIE network and site-specific procedures.
• Apply quality assurance processes and procedures at the corporate level to ensure product quality and regulatory
• Write, review, and implement procedures, specifications, processes, and methods as
• Review executed CGMP records and product batch records to ensure compliance and product quality, when needed.
• Other essential duties as directed

• Bachelor’s degree in chemistry or a related scientific area preferred
• Minimum of 8 years of experience in a CGMP/FDA-regulated environment is required.
• Minimum of 3 years of experience in Project Management.
• Quality & Regulatory Assurance experience preferred.
• Experience and/or full knowledge of manufacturing operations and the preparation of sterile injectables is required.
• Knowledge of relevant USP and FDA regulations, as well as CGMP requirements, is required. Knowledge of how and ability to write, review and revise SOPs is required.
• Familiarity with radiopharmaceutical manufacturing processes and related QC release testing preferred.
• Working knowledge of US and ICH cGMP regulations and guidelines, risk management standards, quality attributes, and Quality Assurance best practices in the pharmaceutical industry required.
• Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision required.
• Ability to effectively communicate (written and verbal) with leadership, site personnel, corporate QA, customers, and regulatory agencies required.
• Ability to prepare and present written and verbal reports to upper management required.
• Domestic travel up to 60%.

About the Company:
SOFIE

SOFIE is motivated by Innovation. Passion. Collective genius. Hard work. We believe in nurturing great ideas and great people. From our Board to our Team, we’re dedicated to bringing a new vision of theranostics and innovative technologies to healthcare.

With our acquisition of Zevacor Pharma, Inc in 2017, we have become SOFIE, a combined company of radiopharmacies, contract manufacturing services, radiosynthesizers, and pre-clinical imaging systems. We are especially excited about the possibilities before us in 2018, as we’ll be offering new products and an expanded network to support our belief in life-changing Theranostics, and continue to lead the way in quality, service, and innovation. Together, we’re on a mission to improve patient lives, from start to clinic. If you want to join us in our mission, visit our careers page and help us change the world

We offer a competitive salary, a comprehensive benefits package, and advancement opportunity. SOFIE is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or other characteristic protected by law.

Company Size:
100 to 499 employees

Industry:
Biotechnology/Pharmaceuticals

Founded:
2017

Website:
https://sofie.com/