Quality Audit Team Manager (Finance)

The Quality Audit Team Manager provides oversight of one or more of the quality audit teams and manages day-to-day operations, supervising team members. Additionally, the Quality Audit Team Manager is accountable for ensuring training needs of their team are addressed, and for the regulatory compliance and policy & procedural compliance of the team.

Education and experience requirements:

• Demonstrated experience in a Supervisory capacity leading QA teams
• 2+ years of leadership experience with a Bachelors Degree in a relevant Life Science
  • OR
• 4+ years of directly related experience with an Associates Degree or HS Diploma

Business and Management requirements (must have at least one)

• Supervisory Training or experience (as approved by the Career Board)
• Business Training or experience (as approved by the Career Board)
• MIT
• M.B.A.

Quality Requirements (must have at least one)

• NRM or NLM
• Quality Certification, CQE, CBA, or CQA
• Sterilization Specialist Certification
• Other job specific certifications (as approved by the career board)

Essential job functions:

• Establish and monitor lab section specialization for Audit Team members
• Oversee the continuous improvement processes efforts of the Audit Team
• Train, supervise, and mentor the Audit Team
• Lead Audit Team meetings
• Review and trend general adverse quality events (unexpected results, retests, deviations, amended reports)
• Review SOPs in MasterControl
• Review protocols, raw data, validations, or final reports as needed
• Perform GLP audits as needed
• Perform Internal Audits as needed/requested by the Internal Audit Coordinator
• Perform other duties as assigned.

Regulatory Compliance

• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc).
• Know and follow company policies and procedures.

Professional Development

• Complete required training on time (includes MasterControl, live company trainings, New Employee Orientation, etc.)

Job requirements:

• Attention to detail
• Proficient verbal & written communication skills
• Ability to work independently
• Decision making/problem solving - creating win/win situations
• Time management- response time, meeting deadlines
• Excellent customer service/interpersonal skills
• Multi-tasking
• Self-motivated/initiative
• Conflict management- diffusing situation and creating win/win situations
• Follow instructions/assist others in following instructions
• Presentation skills/public speaking for dashboards
• Project management (infrequent, but needed)
• Enjoy working with legible handwriting
• Math skills
• Basic computer skills
• Dependable

Physical requirements:

• Must be able to stand and walk in the lab 50% of the day and sit and type at a computer for 50% percent of the day. Lifting is minimal.

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.

Sotera Health goes to market through its three best-in-class businesses - Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.