Posted on 30th July 2019
Senior Director – Site Quality
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 Senior Director Site Quality will proactively develop, lead and contribute to Curium’s Quality strategy from early stages through commercial scale manufacturing in line with customer need and capacity expansion, balancing the business needs with regulatory adherence. The candidate will oversee decisions of the quality assurance and quality control teams while maintaining alignment with Quality Leadership. In doing so, the Senior Director Site Quality will lead all operational Quality matters in the US ensuring independent decision-making of Quality from business to avoid conflict of interest, and will hold accountability for end-to-end Quality oversight for all pharmaceutical products manufactured in the US.
This position oversees the company’s Quality organizational units including Quality Assurance, Quality Control, Quality Operations, and Validation and reports to the Vice President of Compliance. This position will ensure Curium’s programs and processes are in adherence to the latest Quality requirements and industry trends, and will manage to the applicable local, state, federal, and international inspections governing aseptic and parenteral drug products in a finished pharmaceuticals facility as well as Quality compliance of Medical Devices. This individual will provide leadership in development and completion of prevention-based quality awareness and improvement programs. While the scope of this role is North American, the Senior Director Site Quality will support Canada, Europe and elsewhere the products manufacturing at the Maryland Heights Missouri products are distributed.
Domestic relocation is offered for this position.
- Leader and contributor creating a collaborative, accountable, empowered team focused on quality compliance aligned with authority requirements and Curium leadership.
- Conceptualize and set strategic quality direction, determine key strategic quality plan elements, and organize quality goals and objectives into annual and long-range plans.
- Oversee Quality Assurance, Quality Control, Quality Operations, Microbiology, and Validation departments.
- Oversee Quality Assurance departments responsible for Quality Management System (QMS), Quality Management Review, and Quality Metrics including internal auditing program and timely completion of associated corrective actions.
- Oversee Quality Operations ensuring quality support coverage is balanced and appropriate for all manufacturing shifts including supporting nights and weekends as appropriate.
- Oversee Quality Control, Radiation Physics, Microbiology, Analytical, and Validation departments ensuring support for marketed products and collaboration on new initiatives.
- Leader, contributor, and site approver of Root Cause Analysis, Corrective Actions Preventative Actions, Out of Specification and Out of Trend results, Exceptions, Deviations, Quality Protocols, and Change Control implemented to meet site and Health Authority requirements and expectations.
- Responsibility for the review / approval of a GxP procedures, records retention, company documentation, including training records. This includes management of employee training records. Oversee the Company’s Documentation department.
- Oversee the management of external agency inspections, ensuring compliance with policies, procedures and regulatory requirements. Act as key liaison for local, state, federal, and global regulatory agency inspections. Proactively seek to affect change to reduce the number of observations identified during audits/inspections and ensure company is aligned with current regulatory expectations.
- Oversee Quality aspects of complaint processes. Lead company Field Alerts, Field Actions (Corrections and Removals).
- Lead Quality planning for New Product development and Maintenance of Business assuring facilities, processes, and products have detailed prospective strategies for drugs and devices.
- Assure that Research and Development work activities are in GLP / cGMP compliance with all appropriate regulatory requirements and policies for R&D. Oversee the creation and submission of pertinent quality sections for product filings.
- Develop standardized quality metrics based on latest industry knowledge. Report and escalate quality systems issued to VP of Compliance and Executive Management during Management Review meetings.
- Manage the range of performance management processes for team members. Contribute to budgetary processes in collaboration with VP of Compliance and Finance.
- Serves as a technical / quality system resource and collaborate with Manufacturing / R&D / PMO / Supply Chain / Commercial organizational counterparts.
- Interface with medical, regulatory and product monitoring functions to provide a coherent quality strategy in areas of product registration and product vigilance for drugs and devices.
- Actively promote safety rules and awareness, demonstrates good safety practices at all times including appropriate use of protective equipment, report and take initiative to correct safety and environmental hazards.
- Actively demonstrate the Curium values of Integrity, Commitment and Collaboration as well as Accountability, Efficiency, Customer Service, and Safety.
- Bachelor Degree in Chemistry, Life Science, Physical Science or a related science discipline, advanced degree preferred.
- 15 years of progressively increasing Quality department leadership in the manufacture and control of pharmaceuticals. Experience with aseptic, parenteral finished products highly preferred.
- 10+ years of experience in a managerial role, (preferably 3 or more years as a site head of quality) including a demonstrated track record of experience leading people towards meeting the organization’s vision, mission, and goals by providing an inclusive workplace that fosters the development of others, facilitates cooperation and teamwork.
- Significant work experience in a finished pharmaceutical cGMP manufacturing environment is required, strong working knowledge of FDA and EU requirements and guidance documents.
- Prior experience interfacing regularly with and managing inspections performed by FDA, NRC, DOT, DEA and other regulatory bodies.
- Experience developing the ability of others to perform and contribute to the organization by providing ongoing feedback and by providing opportunities to learn through formal and informal methods is required.
- Strong audit background, knowledge of quality improvement initiatives and risk management principles, experience reducing the number of observations identified during audits/inspections is required.
- Experience in a growth-oriented organization with a focus on compliant execution of existing business, addition of products to portfolio and growth in contract manufacturing preferred.
- Functional expertise in pharmaceutical regulatory compliance is required, strong knowledge of compliance in aseptic processing is preferred.
- Experience leading change within an organization is required.
- Lean, Kaizen and / or Six Sigma experience and certification is highly preferred.
- Routine and occasional overnight travel required based on business need.
- Leadership Skills – strong drive to deliver business goals and ensure long term success by creating objectives and committing resources to sustain the future of the organization.
- Management Skills – demonstrated ability to set and communicate clear standards and expectations, develop and support an open environment where challenge is viewed positively. Aware of own impact and what drives and motivates others. Provide coaching and feedback to help employees perform at their best.
- Language Skills – ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers.
- Reasoning Ability – ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- Deals effectively with pressure, remains optimistic and persistent, even under adversity.
- Makes well-informed, effective, and timely decisions, even when data is limited, or solutions produce unpleasant consequences, perceives the implications of decisions and constantly manages risk.
- Develops networks and builds alliances, collaborates across boundaries to build strategic relationships and achieve common goals.
- Persuades others, positively influences and motivates, builds consensus and gains cooperation from others.
- Ability to establish rapport with regulatory agencies and serve as key liaison.
- Standard office environment, 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, some gowning may be required to enter laboratory areas.
- Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
- 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.
Posted on 30th July 2019