<p>Work Schedule</p> <p>First Shift (Days)</p> <p>Environmental Conditions</p> <p>Office</p> <p>Job Description</p> <p>This is an office-based position located in either Middleton, WI or Richmond, VA</p> <p>At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.</p> <p>Location/Division Specific Information</p> <p>Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic authorities. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.</p> <p>Discover Impactful Work</p> <p>Coaches and mentors QA team(s) responsible for defining, managing and improving the quality management system. Assists business development and senior management in securing new business by writing and reviewing proposals, making presentations to potential clients and representing the department at appropriate professional meetings and conferences. Develops effective solutions, using proven problem solving techniques, to address nonconformance issues. Ensures delivery of quality solutions in a collaborative environment with operational departments and clients. Identifies trends, leads process improvement initiatives, and serves as a strategic partner to internal operations regarding continuous improvements.</p> <p>A Day in the Life:</p> <ul> <li>Lead and coordinate the QA team, ensuring flawless execution of all tasks. </li><li>Develop and implement world-class quality assurance policies and procedures. </li><li>Collaborate with cross-functional teams to determine and successfully implement QA strategies. </li><li>Conduct regular audits and reviews to ensure compliance with regulatory requirements. </li><li>Provide mentorship and guidance to team members, encouraging an inclusive and collaborative environment. </li><li>Analyze data and generate reports to monitor key quality metrics and drive continuous improvement. </li><li>Develops and executes compliance strategies and establishes quality and compliance standards within and across GQC business units </li><li>Assures that all quality systems are in place and appropriate to meet business area client and regulatory expectations. Analyzes compliance/quality matrix data, notifies executive leadership of critical compliance nonconformance </li><li>Takes leadership role with peers to proactively identify issues relating to quality and/or data integrity, determines root cause of nonconformance, and develops in collaboration with teams effective problem solution strategies </li><li>Directs assigned department in execution of departmental objectives. Hires, develops, and mentors staff to expand organizations capability and ensures effective management of staff </li><li>Manages contracts to ensure contractual obligations and business requirements are met </li><li>Advises peers, teams, and clients on the interpretation and implementation of regulatory agency trends and requirements </li><li>Assesses impact of client and regulatory observations of data integrity and overall quality management and provides recommendation for corrective action to the respective teams </li><li>Assists in business development activities to obtain additional contracts by writing and reviewing proposals, making presentations to potential clients and representing the department at appropriate professional meetings and conferences </li><li>Fosters client relationships and provides strategic guidance on quality business initiatives. Provides regulatory support for clients as needed for addressing regulatory concerns such as validation issues and agency questions as needed </li><li>Maintains leadership role through active participation in leadership team meetings, presentations to site staff on compliance and quality issues </li><li>Develops and maintains applicable quality metrics. Participates on quality and business process improvement issues </li><li>Handles delegated tasks and responsibility as requested by senior leadership. Represents QA at client audits and regulatory authority inspections </li><li>Maintains expertise with international regulatory requirements by attending external training programs, maintaining current reference library and attending regulatory authority sponsored public conferences </li></ul> <p>Keys to Success</p> <p>Education and Experience</p> <p>Bachelor's degree or equivalent and relevant formal academic / vocational qualification</p> <p>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years).</p> <p>5+ years of management responsibility</p> <p>Proven leadership skills</p> <p>In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.</p> <p>Knowledge, Skills, Abilities</p> <ul> <li>Excellent leadership skills and business acumen </li><li>Advanced knowledge of financial management and budgeting </li><li>Ability to successfully operate in a matrix or team environment </li><li>Ability to handle multiple responsibilities, priorities and tasks </li><li>Excellent verbal and written communication skills inlcuding appropriate use of medical and scientific terminology </li><li>Demonstrated proficiency with regulations and guideline interpretation, proper documentation and QA departmental policies and procedures </li><li>Ability to apply proven problem solving skills </li><li>Ability to apply business and process improvement methodologies </li><li>Ability to manage complex projects on time and within budget </li></ul> <p>Work Environment</p> <p>Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:</p> <ul> <li>Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. </li><li>Able to work upright and stationary and/or standing for typical working hours. </li><li>Able to lift and move objects up to 25 pounds. </li><li>Able to work in non-traditional work environments. </li><li>Able to use and learn standard office equipment and technology with proficiency. </li><li>May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments. </li><li>Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. </li></ul> <p>Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.</p> <p>Apply today! http://jobs.thermofisher.com</p> <p>Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.</p> <p>Accessibility/Disability Access</p> <p>Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.</p> <ul> <li>This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response. </li></ul>