Supervisor, Audits - Quality Compliance

Job description

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information

Cincinnati, Ohio, US

How will you make an impact?

The Audits Supervisor will set team goals for performance and deadlines to comply with Quality Compliance expectations for Client and Corporate Audits as well as Regulatory Inspections. Will build effective teams to apply their diverse skills and perspectives driving engagement and creating a positive climate for career development and to achieve common goals to stay within Compliance while serving our customers.

What will you do?

• Provide leadership to direct reports by leading organizational change and, developing and empowering team to achieve organizational goals

• Manage Internal Audit and Fit & Finish programs at the site

• Manage Audits Team training (onboarding and performance)

• Organize workflow to ensure that team members have defined roles and responsibilities

• Manage scheduling of customer audits and regulatory inspections and, ensures completion of audits are tracked and performed on time.

• Assure current Good Manufacturing practices, company SOPs, and product registrations are followed and maintained

• Lead/host Client and Corporate Audis as well as Regulatory Inspections as needed

• Interpret FDA regulations, comparable international regulations, SOPs, and other company policies and procedures applicable to the site to stay within compliance

• Identifies and applies updates from area SOPs

• Responsible for performance management within the team and represents QA when needed

• Manage and report QA KPIs and relevant Metrics for Audits and inspections

• Performs other reasonable, related Quality and business duties

How will you get here?
Education

Bachelor's degree in Chemistry or other relevant science, required

Experience

• Five (5) years of progressive experience within Quality in areas of QA, QC, or Audits.

• Extensive knowledge of GMPs, GDPs and Regulatory Affairs.

• Qualified Auditor

• Technical and operational knowledge in Quality

Equivalency : Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities

• Strong decision-making skills.

• Ability to handle multiple ongoing activities, and to prioritize tasks.

• Outstanding attention to detail and organizational skills.

• Ability to evaluate and resolve complex technical problems.

• Highly effective verbal and written communication skills at all levels.

• Excellent interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters

• Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented

• Demonstrates ability to maintain a high degree of confidentiality

At Thermo Fisher Scientific, each one of our 80,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.