Senior Manager Quality Assurance

Noblesville, IN, United States

About Curium

Curium is the world's largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name 'Curium' honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline 'Life Forward' represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

The Senior Manager of Quality Assurance in our radiopharmaceutical manufacturing facility will develop, establish and maintain a quality operations platform, ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. May serve as liaison between the company and the various governmental agencies. Work directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specied to enforce requirements and meet specications.

Establish and ensure appropriate Quality Operations are maintained, including ongoing data analysis of product and process outputs to ensure early detection and response to quality concerns, and prevention of quality issues. Establish and ensure compliance with cGMPs, good housekeeping practices, employee hygiene and equipment sanitation; analyze plant error, salvage, spoilage reports and process statistics for signicant ndings and conclusions; work with Research and Development during new product start-ups, and establish key checkpoints for new products and processes.

In general, a Senior Manager of Quality Assurance is responsible for ensuring accountability, transparency, and eective communication cross-functionally and within their team while ensuring information is timely, clear and accurate. By coaching and developing the team to High Performance, will foster a team ownership culture that ensures compliance with all Corporate and Local policies, procedures and regulations. In addition, must supply the highest level of both internal and external customer service. To eectively recognize and reward performance, the Director must measure and communicate the team's progress against individual, team and site goals and Key Performance Indicators (KPI's).

Schedule: Monday - Friday 8am - 5pm

• Manages all aspects of plant Quality Operations including, floor level focus factory quality engineer support, labeling and product release.
• 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.).
• Hire and manage departmental personnel directly and through subordinate supervisors.
• Support an aggressive Quality program which instills personal accountability for accuracy, consistency and completeness for all operations and departments according to site and corporate policies.
• Create and maintain an environment of excellence, world-class quality and continuous improvement throughout the entire plant.
• Responsible to make fact-based, scientifically sound, quality decisions regarding products manufactured at the Maryland Heights facility. These decisions must be made within the requirements of cGMPs and applicable regulatory/industry guidance documents.
• Manage approval or rejection of starting materials, packaging materials, and intermediate, bulk and finished products per the appropriate regulations and documents.
• Ensure the evaluation of batch records.
• Ensure the appropriate process, equipment and facility validations meet expectations for validations, process capability, corrective actions and general compliance for applicable regulatory agencies.
• 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 site 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.
• Hold weekly team meetings to update team and track progress.
• Lead team in continuous improvement activities and take control when faced with adversity while incorporating team input.
• Ensure proper maintenance and cleanliness of the department, premises and equipment.
• Measure and communicate team's progress against individual, team and site goals and Key Performance Indicators (KPI's).
• Recognize and reward performance.
• Lead and/or support investigations. Author, approve and/review area quality and safety exceptions and investigation reports. Ensure on-time completion of all corrective action items assigned to area.
• Verify, review and make appropriate changes if needed, to any controlled document pertinent to area of responsibility.
• Identify opportunities to reduce costs, reduce risk and improve service.
  

• Bachelor Degree in Physical Science, Chemistry or Life Science required. Master Degree preferred.
• 15 or more years of multi-functional Quality experience to include Quality Assurance, with 5 or more years in a leadership role; (preferably managing a team of 10+ employees and multi-shift).
• Expert knowledge of cGMP requirements, specific to Pharmaceutical and/or Chemical industry experience required.
• Complete understanding and application of principles, concepts, practices, and standards for testing performed in QC laboratories.
• 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
• Action oriented/drives for results
• Excellent communication and interpersonal skills
• Team orientation/strong team player
• Ability to coach, mentor and teach
• Excellent and proven decision making, problem solving and analytical skills
• Managerial courage
• Change agent with the ability to influence at all levels of the organization
• 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
• Excellent time management skills
• Technical writing skills
• Manages diversity
• Cross-functional experience
• Lean / Kaizen / Six Sigma experience preferred
• Experience working with High Performance Teams preferred Experience with developing/documenting procedures
  

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.
  

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 anequal opportunity employerand believes everyone deserves respect, dignity and equality.All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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