Thermo Fisher Scientific

Manager, Quality

Thermo Fisher Scientific • $90K — $120K *
Allentown, PA 18102In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree, preferably in a technical or life sciences field; statistics preferred.
  • 5+ years of experience in data management, analytics, or visualization in relevant industries.
  • Strong expertise in GMP and pharmaceutical quality systems.
  • Proficient in technical writing, report preparation, and data interpretation.
  • Demonstrated management experience with direct reports and effective decision-making.

Responsibilities

  • Manage a team of Technical Writers and Investigators overseeing Quality Records across various functional areas.
  • Serve as the Site's Global Trackwise Administrator, generating quality metrics and reports.
  • Track and author investigating reports and audit records as necessary.
  • Generate and report quality metrics for continuous improvement initiatives.
  • Support Commercial Operations by authoring investigations for timely batch releases.

Benefits

  • Adherence to all Good Manufacturing Practices (GMP) Safety Standards.
  • Some degree of Personal Protective Equipment (PPE) required including safety glasses and lab coat.
  • Opportunities for continuous improvement initiatives.
  • Engagement in statistical analysis and data visualization for actionable insights.
Full Job Description
Work Schedule
First Shift (Days)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

What will you do?

  • Management of a team of Technical Writers / Investigators who are responsible for managing Quality Records (Investigations, CAPA's, Change Controls, Audit Records, APR's) across Commercial, Clinical, Supply Shain, and Client Services functional areas.


  • Serve as the Site's Global Trackwise Administrator which includes generation of quality metrics and reports. Job duties also include analyzing, tracking and trending the quality system metrics to support Sr. management with quality improvements.


How will you get here?

Education :

Bachelor's Degree

Responsibilities

  • Applies Good manufacturing Principles in all areas of responsibility.


  • Demonstrates and promotes the company vision.


  • Responsible for tracking and, when necessary, authoring Investigations, Audit records, Annual Product reviews as required.


  • Responsible for generating, tracking, trending and reporting a large set of quality metrics relating to CTD- Allentown business operations and associated clients for continuous improvement purposes. These metrics include but are not limited to:


  • Quality Council Metrics


  • Tier 2 Data


  • Client Specific Metrics


  • Global Metrics


  • New Product Introductions


  • State License Status and adherence


  • Tracks open records in TrackWise to include Deviations, Complaints, CAPAs, observations, APR's and Change Controls to closure.


  • Responsible for managing workload distribution of writers to cover both Commercial and Clinical Operations and Supply Chain to ensure timely closure of Trackwise records.


  • As needed, support Commercial Operations by authoring investigations to support timely batch release.


  • Responsible for compiling and creating presentations for local, global and clients business and quality review.
    • Identify and implement continuous improvement initiatives within the site Quality System business processes.


    • Performed statistical analysis such as regression, clustering, and hypothesis testing to uncover patterns in the data using programming language.


    • Tracks non-conformances and complaints and presents metrics to Senior Management on a scheduled basis.


    • Serves as a resource on regulatory issues, compliance, and internal investigations.


    • Conducts data analysis and data visualization to make actionable recommendations for Quality presentations.


    • Serves as quality lead in all client requested data and reporting needs from a site perspective.


    • Creates reporting, and recommended actions, for follow up on past due Quality Action Items such as Investigations etc.


    • Assist and makes recommendations with drafting and revising QA documents and Standard Operating Procedures (SOP's) as required.


    • Conduct all activities in a safe and efficient manner.


    • Other duties may be assigned to meet business needs.


    Knowledge, Skills, Abilities

    • Bachelor's degree, preferably with a technical or life sciences focus. Statistics preferable.


    • Must have experience in GMP, and pharmaceuticals Quality system and in-depth analytical thinking and understanding of metrics management.


    • Must be able to effectively prepare reports, presentations, metrics and communications with interpretation of data analysis and potential problems with clarity and high level of accuracy.


    • Most have strong technical writing authorship and be able to review reports while effectively inputting and expressing Quality risk management risks.


    • Must be skilled in decision-making, building relationships, problem solving, planning and organizing. Must possess an independent mindset.


    • Should have management experience of direct reports.


    • Must be skilled in authoring investigations, CAPA's, change controls, audit responses.


    • 5+ years of experience performing either data management, data analytics, data visualization, at one of the following industries is strongly preferred: Clinical research organization, technology consulting firm, pharma, medical device, or biotech organization


    • Excellent verbal and written communication and communicate effectively with customers.


    • Understanding of the clinical and commercial packaging and distribution process along with awareness of regulatory documentation requirements preferred.


    • Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.


    Physical Requirements

    • This position is administrative and is positioned in an office environment.


    • It requires standing bending reaching, walking and talking as well as exerting up to 20lbs.


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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