Manager Quality Systems Details

Position: Manager Quality Systems Job Details | curium
Location: Maryland Heights

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 Manager of Quality Systems for North America will develop, establish and maintain efficient quality systems, ensuring that performance conform to established standards and agency guidelines and to drive alignment and continuous improvement across regional sites. Continuously stays current on changes to regulations and guidance as well as industry trends. Provide guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance and alignment across facilities.

Establishes the framework for Quality Management Review. Manages the Data Integrity Program.

Establish and ensure appropriate Quality Systems are maintained which allows sites to have ongoing data analysis of product and process outputs to ensure early detection and response to quality concerns, and prevention of quality issues. Manage and oversee aspects of the Quality Management System (QMS) including but not limited to investigations, CAPA, change control, internal audit, training, and stability program.

The Manager of Quality Systems is responsible for ensuring accountability, transparency, and effective communication cross-functionally and within their team while ensuring information is timely, clear and accurate. By coaching and developing their team to High Performance, will foster a team ownership culture that ensures compliance with all Corporate and Local policies, procedures and regulations. In addition, the Manager of Quality Systems must supply the highest level of both internal and external customer service and collaborate with various functional groups.

To effectively recognize and reward performance, the manager must measure and communicate the team's progress against individual, team and site goals and Key Performance Indicators (KPI's).

Work Schedule:

Monday Friday 7am 4pm

Essential Functions

• Manages the regional Quality Systems, including training, deviation reporting, CAPA, Out of Specification reporting, LIMS.
• Continuously reviews the quality system to identify ways to improve efficiency and compliance while meeting the business needs.
• Drive alignment between sites within the region by identifying best practices and standardizing procedures and programs.
• Provide administrative support to the electronic platforms associated with QMS.
• Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
• Manage investigation and CAPA programs. Perform reviews on critical investigations, as needed. Head Regional Investigation and CAPA review boards to ensure records are robust and complete.
• Maintain the regional Quality Manual, regional policies and regional procedures. Manage change control program for the region, including leading change review boards, as needed.
• Provide consultation related to the QMS to other global Curium sites.
• Oversee the stability program for the region. Review stability protocols and reports to ensure compliance with specifications and detect trends. Ensure programming alignment with regulatory guidance.
• Oversee training platform for the region. Standardize training curricula and review training modules as needed. Identify training improvements and leverage technology as applicable.
• Provide administrative support to the electronic training system.
• Administer Quality KPIs and lead regional Quality Management Review (QMR). Develop targets based on industry and historical site performance.
• Manages the Data Integrity program and ensure alignment across the sites within the region.
• Support an aggressive Quality program which instils personal accountability for accuracy, consistency and completeness for all operations and departments according to regional and corporate policies.
• Responsible to make fact-based, scientifically sound, quality decisions regarding products manufactured at the North American sites. These decisions must be made within the requirements of cGMPs and applicable regulatory/industry…