Director Quality Validation

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 Director Quality Validation ensures Validation activities for product development, process improvement, and commercial manufacturing. Ensures system and process changes are properly documented and qualified as required. Ensures documentation issuance and retention is completed per site and regulatory requirements. Ensures accountability, transparency, and effective communication cross-functionally and within validation team while ensuring information is timely, clear and accurate. Coaching and developing will foster team ownership that ensures compliance with all policies, procedures, and regulations. In addition, must supply the highest level of both internal and external customer service and measure and communicate the team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s).

Work Schedule: Monday – Friday 8am – 5pm

Essential Functions

• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOPs.
• 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.).
• Ensure the validated state of the Noblesville facility.
• Develops and establishes the site validation plan to ensure compliance with health authority requirements. Leads a team that schedules and performs validation activities (IQ, OQ, PV, PQ) for new and existing equipment, cleaning, processes, systems, methods, facilities and utilities for the site.
• Develops Key Performance Indicators (KPI’s) for area and reports updates. Develops action plans when required.
• Approves validation documentation such as but not limited to protocols, deviations, and summary reports, as required.
• Ensures area has appropriate procedures and documentation which is current and maintained for tasks. Ensures personnel are properly trained.
• Review and approved Change Control, CAPA and other related documents, as required.
• Maintain current knowledge of US and International regulations regarding validation and cGMPs and proactively champion validation initiatives to meet same.
• Lead and own all Computer System Validation and Data Integrity activities at the site.
  
  

Requirements

• Bachelor Degree in Engineering, or related life sciences degree required.
• Twelve or more years of relevant Validation experience, with three or more years of experience in a leadership role required.
• Working knowledge of global cGMPs to comply with US and international regulatory agencies and finished pharmaceutical manufacturing requirements.
• Knowledge with at least two of the following: lyophilizers, autoclaves, VHP, isolators, computer systems, cleaning, process, automated fillers, stopper processors, CIP/SIP, depyrogenation ovens, thermal units, WFI and Clean Steam systems or HVAC.
• Results-oriented, able to make decisions and prioritize work per business needs in a fast-paced environment.
• Strong communication, organization and time management skills are necessary.
• Strong problem solving, decision making, verbal and written communications skills.
• Proficient in use of Microsoft suite of products.
• Frequent partnering with Production, Engineering and QC departments.
  
  

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.
• Domestic and international travel, up to 10%, may be required.
  
  

Competencies

ANALYZE ADAPT

COMMUNICATE EFFECTIVELY

DEVELOP SELF OTHERS

INTERNAL/EXTERNAL CUSTOMER-FOCUSED

RESULTS-DRIVEN

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.