Thermo Fisher Scientific

Clinical Program Quality Excellence Lead - FSP Team

Thermo Fisher Scientific • $110K — $130K *
US-AnywhereRemote in North Carolina, US
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • 6+ years of clinical research experience in pharmaceuticals or biotechnology
  • Solid knowledge of GCP compliance and regulatory inspection readiness
  • Experience with CROs and outsourcing clinical trial activities, sponsor experience preferred
  • Proficient in clinical trials systems, especially Veeva
  • Strong project management and communication skills
  • Bachelor's degree preferred or equivalent experience

Responsibilities

  • Facilitate cross-functional teams' GCP inspection readiness activities
  • Manage inspection readiness planning and develop necessary documentation
  • Guide study teams on adherence to operational processes
  • Engage SMEs in inspection readiness and risk assessment
  • Oversee TMF performance ensuring compliance and inspection readiness
  • Coordinate activities for internal audits and regulatory inspections
  • Provide just-in-time guidance and action compliance monitoring signals

Benefits

  • Standard Monday to Friday work schedule
  • Office environment
  • Opportunity for cross-functional collaboration and influence
  • Continuous improvement and professional development initiatives
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

OBJECTIVES/PURPOSE
  • Facilitate and manage cross-functional teams' GCP inspection readiness and execution activities throughout the study lifecycle
  • Embed real-time inspection readiness strategies into daily operations in collaboration with study teams, aligned with Global Development Compliance and Clinical Quality Assurance.
  • Ensure high-quality deliverables for global studies or programs by guiding study teams on adherence to operational processes and well-prepared documentation
  • Champion proactive and continuous prioritization of inspection readiness, focusing on key study operational processes and GCP process excellence, including TMF quality strategies, study-level risk assessments and actioning compliance monitoring signals


ACCOUNTABILITIES
  • Provide just-in-time guidance to study teams on key operating model processes and required documentation, prioritizing real-time inspection readiness
  • Manage and guide teams on inspection readiness planning, including developing and maintaining inspection readiness plans and tools in collaboration with cQA and GCP Excellence in Clinical Trials leadership.
  • Facilitate development of key inspection deliverables including but not limited to required listings, functional presentations, issue related storyboard development, and study team preparation for audits and inspections
  • Action compliance monitoring signals and study health metrics with teams to mitigate real-time issues
  • Engage appropriate Sponsor and CRO SMEs in inspection readiness activities and study-level risk assessment investigations
  • Oversee and manage overall TMF performance and processes, including risk-based oversight strategies and adherence to TMF Plan and TMF Index, to ensure compliance and inspection readiness, including the cross-functional study team and outsourced elements to the CRO.
  • Lead and participate in Strategy Team Meetings and Lead Core Team Meetings for assigned projects
  • Ensure effective communication and issue escalation internally and externally with vendors
  • Maintain project management documentation such as plans, timelines, and progress reports for ongoing inspection readiness
  • Coordinate key activities to enable study team readiness for internal study audits and regulatory inspections, including management of required listings and study team preparedness
  • Manage functional teams during inspections, collaborate with SMEs, provide follow-up, and ensure timely fulfillment of requests and responses.
  • Facilitate and monitor study-specific CAPA related activities in collaboration with GCP Compliance Management and QA
  • Identify and implement improvements in inspection readiness and study execution processes.
  • Provide regular status updates to stakeholders and leadership.
  • Ensure alignment with functional SMEs and cQA in real time throughout study lifecycle and during audits and inspections.


Technical/Functional (Line) Expertise
  • Comprehensive understanding of the pharmaceutical industry (e.g., clinical development, operating models, the prescription drug distribution process, etc)
  • Effective project management leader
  • Advanced expertise in GCP, ICH and applicable global and local regulatory standards governing clinical research
  • Advanced expertise in complex Trial Master File deliverables, TMF structures and electronic document management systems (ie.CTMS, SSU, eTMF), Veeva preferred
  • Strong ability to learn new systems and technology quickly and provide training to cross-functional study teams
  • Demonstrated abiltity to monitor, interpret and action key performance metrics including study compliance and TMF health data


Leadership
  • Demonstrated ability to work across functions, regions and cultures
  • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
  • Proven skills as an effective team player who can influence stakeholders, engender credibility and confidence within the company
  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
  • Navigation of changing priorities and communication managment
  • Managing deliverables; demonstrating the ability to lead others to drive deliverables forward


Decision-making and Autonomy
  • Accountable for implementing resourceful and effective strategies for cross functional team performance; ability to make independent decisions for designated function; escalation of issues as needed.
  • Ability to work in a fast-paced environment with demonstrated ability to manage mulitple competing tasks and demands.
  • Ability to work with timelines and complete tasks according to deadline.


Interaction
  • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
  • Effectively resolve conflict in a constructive manner
  • Ability to collaborate effectively with internal and external study team including vendors as needed


Innovation
  • Ability to take risks implementing innovative solutions; comfortable with flexibility to adapt to changing environment.
  • Applies lessons learned to continuous improvement of GCP excellence, training and documentation management practices across study teams


Complexity
  • Ability to work in a global ecosystem (internal)
  • Requires strong attention to detail in oversight and completion of competing delivarables
  • Ability to take ownership and manage tasks, as well as communicate effectively, establishing priorirties, scheduling and monitoring deadlines for multiple complex studies or programs


EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
  • Minimum of 6+ years clinical research experience in pharmaceutical or biotechnology field
  • Solid knowledge of and experience in GCP compliance, regulatory inspection readiness and study execution processes
  • Experience with CROs and outsourced clinical trial activities, sponsor experience preferred
  • Solid knowledge of drug development and clinical trial processes, including related standards and documents.
  • Experience in clinical trials systems management and oversight (Veeva preferred)
  • Proven awareness of sponsor oversight requirements and regulations
  • Experience in problem solving, negotiations and collaborative team building with non- direct reports and other stakeholders is required
  • Strong project management and communications skills to effectively assess risks, establish priorities, take initiative, and meet deadlines
  • Must be able to work in a fast-paced, changing environment with demonstrated ability to prioritize multiple competing tasks and demands
  • Solid knowledge of regulatory requirements governing clinical trials and industry best practices
  • Bachelor's degree preferred or commensurate with experience
  • Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations

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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