Thermo Fisher Scientific

Manager, Audits & Inspections - Quality Systems & Compliance

Thermo Fisher Scientific • $100K — $120K *
Greenville, NC 27858In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific, information management, engineering, or related field
  • Minimum 5 years of supervisory or managerial experience
  • At least 7 years in the pharmaceutical or medical device industry
  • 5 years in quality assurance or quality systems experience
  • Strong knowledge of relevant regulatory guidelines such as 21 CFR and ISO standards

Responsibilities

  • Oversee scheduling and hosting of external client audits as primary point of contact
  • Plan and manage mock and regulatory inspections with agencies like FDA and EMA
  • Ensure documentation is properly managed for audits and inspections
  • Coordinate responses to audit/inspection findings and track corrective actions
  • Communicate clearly across teams for audit and inspection support
  • Lead and mentor staff on quality matters and compliance training

Benefits

  • Health, dental, and vision insurance
  • Retirement savings plan with employer match
  • Opportunities for professional development and training
  • Paid time off and holiday leave
  • Flexible work environment with standard Mon-Fri schedule
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Manager, Quality Systems & Compliance - Audits & Inspections

A Manager, Quality Systems & Compliance-Audits & Inspections is responsible for the quality oversight of the Client audit and Regulatory inspection programs. The manager will ensure expectations, and regulatory compliance to the following guidelines: 21 CFR Part 210/211 current Good Manufacturing Practice, 21 CFR Part 600 Biologics, 21 CFR Part 820 QMSR, ISO 13485, ISO 9001, and ICH Q9 and Q10. The manager leads the quality compliance, manages internal and external audits, and ensures inspection readiness for regulatory agency reviews. The Manager oversees cross-functional audit and inspection readiness by coordinating mock inspections and coaching subject matter experts. This role is a people leader role that manages direct reports at different organizational levels.

Key Responsibilities
  • External Audit Preparation & Execution: Oversee scheduling, hosting, and responding to external client audits serving as the primary point of contact for prospective and existing clients requesting audits.
  • Inspection Readiness & Execution: Plan, execute, and manage mock and actual regulatory inspections with health authority agencies such as FDA, EMA, ANVISA, and MHRA.
  • Documentation & Record retention: Ensure critical documentation is appropriately documented and stored to support client audits and regulatory inspections.
  • CAPA Management: Coordinate and oversee review and response to audit/inspection observations including tracking the implementation and effectiveness check of assigned corrective actions and preventive actions assigned to address compliance gaps and prevent recurring issues.
  • Communications: Utilize effective communication channels, tools, and resources to ensure appropriate awareness, coordination, and cross-functional support for client audits and regulatory inspections.
  • People Management: Lead, mentor, and coach functional and support personnel on quality matters involving the Audit & Inspection program. Ensure all personnel complete their training to maintain compliance. Encourage teamwork among personnel to enhance cross-functional skills.


Minimal Requirements
  • Education: Bachelor's degree in a scientific, information management, engineering, or related field.
  • Experience: At least 5 years of supervisory or managerial experience with direct reports
  • Experience: At least 7 years of experience working within the pharmaceutical or medical device industry
  • Experience: At least 5 years of experience working in quality assurance and/or quality systems within the pharmaceutical or medical device industry.

Skills:
  • Strong working knowledge of 21 CFR Part 210/211 current Good Manufacturing Practice, 21 CFR Part 600 Biologics, 21 CFR Part 820 QMSR, ISO 13485, ISO 9001, and ICH Q9 and Q10
  • Excellent communication and interpersonal skills with the ability to collaborate cross-functionally and communicate complex quality concepts to stakeholders at all levels
  • Strong problem-solving skills with a proven track record in issue resolution
  • Proficient in electronic quality management systems such as Documentum, Veeva Vault, and TrackWise
  • Strong organizational and time management skills to meet critical business and functional timelines
  • Detail oriented with keen eye for identifying process improvement opportunities
  • Strong relationship-building skills with the ability to work effectively in team environments across all organizational levels

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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