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Senior Director, Site Quality
4 months ago
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 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 Noblesville Indiana products are distributed.
Essential Functions
Leader and contributor creating a collaborative, accountable, empowered team focused on quality compliance aligned with authority requirements and Curium leadership. Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.). 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 Operations, 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. 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.
Requirements
Bachelor Degree in Chemistry, Life Science, Physical Science or a related science discipline, advanced degree preferred. 20 or more years of progressively increasing Quality department leadership in the manufacture and control of pharmaceuticals required. Experience with aseptic, parenteral finished products highly preferred. 10 or more years of experience in a leadership role required, (preferably three 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 US and international regulations / guidance (i.e. FDA, HC, TGA, EU, etc.). Prior experience interfacing regularly with and managing inspections performed by regulatory agencies (i.e. FDA, HC, EU, TGA, NRC, DOT, DEA, etc.).. 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.Working Conditions:
Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels. Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment. Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury. Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed. May be required to sit or stand for long periods of 8+ hours a day while performing duties. Must possess good hand-eye coordination; close attention to detail is required. Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants. Willingness to complete safety training within allotted timeframes, and work in a team-based environment. Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.