Manager Quality Assurance

Company: CURIUM
Location: Noblesville
Posted on: May 24, 2023

Job Description:

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.

Summary of Position The Manager of Quality Assurance position reports directly to the Director-Quality Compliance. The Manager of Quality Assurance is responsible for implementing and supporting the Quality Management System (QMS) in accordance with GMP regulations as well as Company and site policies and procedures. Essential Functions

• Hiring and managing department personnel
• 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
• Provide leadership for employee relations through effective communications, coaching, training and development. Eliminate roadblocks for the team to move forward.
• Recognize and reward performance.
• Write, revise, review, and approve site procedures and policies.
• Review and approve investigations and associated CAPAs
• Leads regulatory agency (i.e. FDA, etc.) inspections
• Investigate or serve as GMP QA approver for customer complaints, deviations / out of specifications ensuring root causes and corrective actions are appropriately identified to reduce / prevent recurrence, within required timeframes and documented
• Assemble, analyze and report QA data (metrics) to ensure regulatory compliance, identify trends and to identify areas of improvement
• Review Batch Records and provide final product disposition
• Conducts internal audits of GMP Quality Systems and sub systems
• Aide in assessing risk during Vendor Qualifications or Material Assessments
• Conducts incoming material disposition
• Reviews and assesses in-house solution preparation and external material testing
• Conducts GMP Vendor Qualification and reevaluations
• Review and compile the Annual Product Quality Review
• Ability to adapt quickly in a fast-paced dynamic environment
• Ability to communicate with and positively influence broad and diverse populations within and outside the organization. Requirements
  • Bachelor Degree in Life Sciences (e.g., Chemistry, Biology, Engineering) or related field
  • Minimum of seven years of GMP Quality leadership relevant experience in a pharmaceutical manufacturing environment with strong understanding of applicable quality management systems required.
  • Two or more years of previous people management experience is required.
  • Must be thoroughly familiar with applicable regulatory guidelines concerning the establishment, validation, and documentation of test procedures, equipment, processes and facility systems
  • Significant experience in investigation deviations or other variances
  • Must possess strong problem/decision making skills
  • Thoroughly knowledgeable of cGMP regulations and guidelines and their application in a controlled aseptic environment (FDA and EU requirements/ guidance documents)
  • Must be able to work with other groups to seek understanding and resolve issues, close gaps, and seek compliant outcome 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.
    • Must be able to physically negotiate stairs and evacuation ladders with or without accommodation, to wear and operate safety equipment, enter vessels, inspect equipment, drive forklifts.
    • Must be able to wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.
    • Willingness to work in a team-based environment.
    • Close attention to detail required.
    • May be required to stand or sit for long periods of time while performing duties. Must be able to stand 8+ hours a day.
    • Responsibilities also include the ability to lift heavy objects (50 to 70 pounds), kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, and reach with or without accommodation.

Keywords: CURIUM, Noblesville , Manager Quality Assurance, Executive , Noblesville, Indiana