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curium jobs

Posted on 4th December 2019

Manager of Quality Operations

United States
Quality
Permanent
1384

About Curium

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 Manager of Quality Operations at the Curium Maryland Heights radiopharmaceutical manufacturing facility will manage a group of Quality Engineers who ensure that performance and quality of products conform to established standards and agency guidelines while providing lasting customer satisfaction. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. While working directly with the operating entities, ensure compliance through execution under the site QMS (Quality Management System) such as but not limited to Change Controls, Internal Auditing, CAPA, Exceptions, OOS (Out of Specification), Customer Complaints and Annual Product Reviews. Develop and implement data analysis / trend analysis methods to correct issues as well as proactively identify and implement items to enhance quality through continuous improvement. Work with Research and Development during new product start-ups and establish key checkpoints for new products and processes. Ensure accountability, transparency, and effective communication cross-functionally and within his/her team while ensuring information is timely, clear and accurate. By coaching and developing his/her team to High Performance, he/she will foster a team ownership culture that ensures compliance with all Corporate and Local policies, procedures and regulations. He/she must maintain operational compliance with U.S. and international regulatory agencies (i.e. FDA, ANSM, etc.). 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).

Essential Functions

  • Manages focus factory quality engineer support.
  • Hiring and managing department personnel.
  • Ensure accountability, transparency, and effective communication cross-functionally and within the team while ensuring information is timely, clear and accurate.
  • Coach and develop the team to High Performance while fostering a culture of team ownership.
  • Set clear vision by ensuring goals and objectives are aligned with site strategies and managing each team member’s performance management.
  • Provide leadership for employee relations through effective communications, coaching, training and development and eliminate roadblocks for the team to move forward.
  • Understand and provide education and feedback to team regarding business and financial impact of decisions/actions.
  • Recognize and reward performance • Efficient, quality / regulatory compliant operation.
  • Key personnel for FDA or other regulatory agency audits.
  • Responsible to make fact-based, scientifically and/or statistically sound, quality / regulatory compliant decisions regarding products manufactured at the Maryland Heights facility including supporting / deciding on material disposition.
  • Provide QA Operations oversight and approval of validations to not only meet applicable regulatory requirements but also ensure proper process capability.
  • Ensure team compliance with all policies, procedures and site/company regulations.
  • Ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.
  • Measure and communicate team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s).
  • Develop and implement data analysis / trend analysis methods to correct quality issues. Proactively identify and implement items to enhance quality through continuous improvement. The outcome of this is reduced costs, reduced risk and/or service improvement.
  • Author or review / approve quality investigations, CAPAs and change controls including SOP changes to drive for resolution through root cause analysis. Ensure on-time completion of items.
  • Conduct quality audits.
  • Participate in MRB (Material Review Board).

Requirements

  • Bachelor’s degree in Life Science (i.e. Chemistry, Biology, Engineering) required.
  • 7 or more years of Quality Operations experience in a finished pharmaceutical manufacturing environment with strong understanding to applicable quality management systems.
  • 2 or more years of prior supervisory or management experience.
  • Statistical, Lean Manufacturing or Six Sigma knowledge strongly preferred.
  • Significant experience in investigating exceptions or other variances.
  • Must be thoroughly knowledgeable with pharmaceutical cGMP requirements including strong working knowledge of FDA and EU requirements / guidance documents.
  • Must be able to work with other groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust.
  • Must possess strong problem / decision making skills .
  • Prior experience supporting inspections performed by FDA and foreign Regulatory Authorities.
  • High level of proficiency in Microsoft Windows and Office Suite (Word, Excel, Power Point and Access), advanced computer skills.
Skills/Competencies:
  • Action oriented/drives for results
  • Excellent communication and interpersonal skills
  • Ability to coach, mentor and teach
  • Excellent and proven decision making, problem solving and analytical skills
  • Detail-oriented with the ability to work under tight deadlines
  • Ability to handle multiple priorities
  • Excellent conflict management skills
  • Learning/change agility
  • Builds positive relationships with others
  • Technical writing skills
Preferred Skills/Qualifications:
  • Lean / Kaizen / Six Sigma experience
  • Experience working with High Performance Teams
  • Cross-functional experience
  • Experience with developing/documenting procedures

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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