Posted on 28th June 2018
Vice President of Compliance
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. Our North American headquarters is in Maryland Heights, MO. Come grow with us!
Scope of Position:
The Vice President of Compliance will proactively develop, lead and drive the execution of Curium’s assurance and regulatory strategy from early stages through commercial scale manufacturing in line with customer need and capacity expansion, balancing the business needs with regulatory compliance. The candidate will act as decision maker for all operational Quality matters in the US, ensure 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 assurance, quality control, quality systems, regulatory affairs and compliance functions and related processes and ensures Curium’s programs and processes are in adherence to the latest regulatory requirements and industry trends, and manages the applicable local, state, federal, and international inspections governing aseptic and parenteral drug products. While the scope of this role is North American, the VP will support US and Canadian regulatory governance in Europe and elsewhere as the leader that holds the relationship and expertise of these governing bodies and their respective regulations.
Domestic relocation is offered for this position.
- Develop and manage the internal auditing program and collaborate with others in Operations to ensure compliance. Plan and execute compliance audits of internal operations as they relate to GxPs, and drive timely completion of associated corrective actions.
- Manage the Company’s Documentation department and Quality Management System (QMS) responsible for the review / approval of a GxP procedures and records retention. This includes the company-wide Training group responsible for the determination of training needs and management of employee training records.
- 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.
- Manage the Product complaint processes including complaint tracking, investigation summary, and customer replies. Lead company Field Alerts, Field Actions (Corrections and Removals) and adverse event reporting with all regulatory agencies as appropriate.
- 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 product filings.
- Track and trend compliance issues to assure alignment with corporate standards. Oversee and review recommendations and implementation of improvements induced by new regulations, agency guidance documents, industry standards, new technologies and internal needs
- Develop standardized quality metrics based on latest industry knowledge. Report and escalate quality systems issued to Executive Management during Management Review meetings.
- Respond timely to compliance concerns and contribute to problem resolution. Manage multiple compliance projects, realigning resources and priorities to meet challenging timeframes
- Conduct ongoing surveillance of worldwide regulations and establish procedures and policies to comply with ever-changing regulatory environment. Maintain awareness of science and industry trends, integrate appropriately into work focus.
- Manage the range of performance management processes for team members. Contribute to budgetary processes in collaboration with management team.
- Maintain current knowledge of global regulatory agency trends and communicates these and related implications throughout respective functional groups. Maintains current expertise in all related external regulatory requirements, technology, and internal systems, processes and procedures.
- Maintain current knowledge of and ensure all functional work team activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures.
- Oversee the creation and maintenance of compliance metrics, development of trend data of audit/inspection observations and communication of results expediently to applicable groups.
- Serves as a technical / quality system resource and collaborate with Manufacturing / R&D / PMO / Supply Chain / Commercial organizational counterparts.
- 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 level degree in a related medical, science or business discipline or equivalent training and formal experience, advanced degree preferred.
- 15 years of progressively increasing Quality and Regulatory leadership experience or comparable compliance discipline within the pharmaceutical industry required including interfacing regularly with FDA, NRC and other regulatory bodies.
- Minimum of 10 years of supervisory experience, 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.
- 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.
- Experience leading regulatory agency inspections, ensuring compliance with policies, procedures and regulatory requirements, experience overseeing or acting as liaison for local, state, federal, and global regulatory agency inspections.
- Experience overseeing, leading multiple complex regulatory submissions for new products and ongoing regulatory activities for existing business.
- Strong audit background, knowledge of quality improvement initiatives and risk management principles, experience reducing the number of observations identified during audits/inspections is required.
- Significant work experience in a finished pharmaceutical cGMP manufacturing environment 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 and / or Six Sigma highly preferred.
- Routine and occasional extensive 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, and the general public.
- 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.
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