Manager Quality Systems

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 guidance documents.
• 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.
• Ensure team compliance with all policies, procedures and site/company regulations.
• Set clear vision by ensuring goals and objectives are aligned with regional strategies and managing each team member’s performance management.
• Exhibit accountability and responsibility for an area or process in order to affect change and lead efforts and ideas to completion.
• Provide leadership for employee relations through effective communications, coaching, training and development and eliminate roadblocks in order for the team to move forward.
• Supply the highest level of internal and external customer service while having the ability to diplomatically challenge established procedures and systems.
• Understand and provide education and feedback to team regarding business and financial impact of decisions/actions.
• Ensure all direct reports maintain ALARA and manage their daily activities accordingly to ensure they meet their quarterly ALARA goals.
• Lead team in continuous improvement activities and take control when faced with adversity while incorporating team input.
• Measure and communicate team’s progress against individual, team and site goals and Key Performance Indicators (KPI’s).
• Identify opportunities to reduce costs, take appropriate risk based approaches, and improve service.

Requirements

• Bachelor Degree in or Life Science required. Advanced degree preferred.
• Twelve or more years of progressively increasing Quality pharma experience to include Quality Systems, with two or more years in a leadership role required; (preferably managing multiple sites or multi-shift).  Radiopharmaceutical experience preferred.
• Expert knowledge of cGMP requirements, specific to Pharmaceutical and/or Chemical industry experience required.
• Expertise in the manufacture and control of finished sterile injectable products, analytical analysis techniques and statistical quality control.
• Strong working knowledge of US and international requirements and guidance documents.
• Thorough understanding of Quality systems.  Ability to use relevant software packages to process and analyze data.
• Prior experience managing inspections performed by US and international Regulatory Authorities.
• High level of proficiency in Microsoft Windows and Office Suite (Word, Excel, Power Point and Access), advanced computer skills.
• Lean / Kaizen / Six Sigma experience preferred.
• Experience working with High Performance Teams preferred.
• Cross-functional experience preferred.
• Experience with developing/documenting procedures preferred. 

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.