Posted on 17th March 2019
Data Integrity Manager
Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.
Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide.
At Curium, every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”. We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration. Come grow with us!
Summary of Position
The Data Integrity Manager is responsible for the development, implementation, and management of an effective Data Integrity Program at the Curium radiopharmaceutical manufacturing facility located in Maryland Heights, Missouri. The position is responsible for the governance of Data Integrity throughout product and GxP system lifecycles in conformance with regulations, established standards, and agency guidelines. The Data Integrity Manager will have responsibility for compliance of the site’s GxP Electronic Quality Management systems through direct leadership of the Quality Systems Analysts. The position will play a key role in identifying improvement initiatives and driving a culture of continuous improvement at the site.
This Data Integrity Manager will report to the Director of Quality Systems. The Data Integrity Manager has a responsibility to support all areas of the site for overall compliance and adherence as it relates to Data Integrity. While the scope of this role is the Maryland Heights facility, the Data Integrity Manager may also be expected to provide support for other Curium locations in the US, Canada, Europe, and elsewhere relative to Data Integrity.
- Lead site in Data Integrity compliance efforts in conformance with current regulations and agency guidelines
- Drive implementation of Data Integrity Program through coordination and execution of cross-functional deliverables by partnering with area, system and equipment owners, and qualification leads.
- Ensures attributable, legible, contemporaneous, original, and accurate data is maintained throughout the data lifecycle
- Responsible for the full system lifecycle of the Electronic Quality Management Systems from design, configuration, testing, validation, and implementation to maintenance and application support.
- Provide direct leadership to the site Quality Systems Analysts responsible for the administration of the Electronic Quality Management Systems.
- Provide Quality oversight of the sites GxP computerized systems and software, including approval of associated qualifications/ validations.
- Direct Data Integrity assessments and risk-based remediation plans for Quality Control Analytical Instruments and manufacturing equipment.
- Ensure effective data and system level audit trail review processes and procedures
- Develop, maintain, and deliver training materials on Data Integrity subject matter
- Responsible for periodic GxP system evaluations
- Facilitate Data Integrity Community of Practice
- Participate in audits and regulatory inspections and represent site on Data Integrity efforts
- Bachelor Degree in Physical Science, Chemistry or Life Science required. Master Degree preferred.
- Seven or more years of Quality Assurance experience in pharmaceutical manufacturing, GMP regulated environments required.
- Two or more years of supervisory experience required.
- Five or more years of experience and in-depth knowledge of GxP computer system validation.
- Two or more years of experience and in-depth knowledge of Data Integrity requirements.
- Expert knowledge of 21 CFR Part 11, GAMP5, and current regulatory guidance on Data Integrity.
- Strong working knowledge of US and EU cGMP regulations applicable to pharmaceutical and medical device industries.
- Proficient in Microsoft Windows and Microsoft Office Suite products.
- Actively demonstrate the Curium values of Integrity, Commitment, and Collaboration as well as Accountability, Efficiency, Customer Service, and Safety.
- Action oriented/ drives for results
- Excellent communication and interpersonal skills
- Team oriented/ strong team player
- Ability to coach, mentor, lead, and teach
- Excellent decision making, problem solving, and analytical skills
- Managerial courage
- Change agent with the ability to influence at all levels of the organization
- Detail-oriented with the ability to work under tight deadlines
- Ability to handle multiple priorities
- Excellent conflict management skills
- Learning/ change agility
- Ability to assess and manage risk
- Builds positive relationships with others
- Excellent time management skills
- Strong technical writing skills
- Manages diversity
- Deals effectively with pressure
- Remains optimistic under adversity
- Standard office environment, coupled with time in radiopharmaceutical manufacturing and laboratory environments.
- Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
- Must be willing to wear a variety of personal protective equipment and gowning to enter certain areas.
- Willingness to work in a team-based environment.
- May be required to sit or stand for long periods of time while performing duties.
- Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
- Must be able to work outside of regular work hours.
- May be required to work weekends and holidays to support operations.
- Domestic and international travel will be required.
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.