About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

Summary of Position

The Quality Project Manager will organize, manage, and plan complex projects for the organization's product implementation efforts. Responsibilities include working with Quality department leaders in the development, implementation, and ongoing improvements for new and existing equipment, products and/or processes. Facilitate quality improvements through project management tools and tactics, establish and improve workflows and processes, planning schedules for the department, while working to ensure project milestones are completed on time and to specifications.

Essential Functions

• Works with quality leaders to set appropriate quality standards and parameters to meet required specifications for quality, function, and reliability prior to delivery.
• Interacts with manufacturing, regulatory, finance, research and development, marketing, and other relevant departments as appropriate to break down project tasks into manageable steps, assign tasks to team members, and track progress towards completion.
• Identify potential risks that could impact project quality or timelines; reports identified risks to leadership; provides recommendations for mitigating risk.
• Acts as a liaison between the Quality department and other departments. Facilitates quality standards and parameters, communication between project stakeholders (e.g., scientists, engineers, quality assurance and vendors), and prepares reports on project progress, risks, and issues.
• Coordinates product testing processes and supports the identification and analysis of issues, defects, and other problems, recommending and facilitating solutions to these issues.
• Assists in defining project scope, oversees Quality workstreams for projects, timelines, budget, and resource allocation for GMP-related quality initiatives.
• May be responsible for coordinating efforts for Quality projects within the firm and through a variety of vendors.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

Requirements

• Bachelor Degree in scientific discipline required or equivalent work experience.
• 8 or more years of relevant Quality experience, with 2 or more years of experience in a project / direct or matrix leadership role.
• Ability to work independently and as part of a team.
• Strong knowledge of cGMP requirements, knowledge of laboratory equipment/product validation. Pharmaceutical manufacturing industry experience preferred.
• Knowledge of regulatory (FDA, EU, ISO, USP, etc) requirements and applicable testing Guidelines.
• Excellent time management skills with a proven ability to meet deadlines, verbal and written communication, interpersonal and customer service skills, organizational skills and attention to detail.
• Strong analytical and problem-solving skills, strong coordination, and matrix / project leadership skills.
• Thorough understanding of or the ability to quickly learn about the project or product being developed.
• Proficient with Microsoft Office Suite or related software.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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