Sr QTS - Pharm

  • Morrisville
  • Thermo Fisher Scientific
<b>Work Schedule</b> <br>Standard (Mon-Fri)<br> <br> <b>Environmental Conditions</b> <br>Office<br> <br> <b>Job Description</b> <br> <br>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.<br> <br>Oversees the coordination of training and/or quality programs, initiatives and activities. Schedules training for new employees, identifies training gaps and develops and delivers training programs and curriculums to promote continuous improvement. Coordinates, leads and/or performs quality reviews of <br>customer interactions and associated documentation, provides analysis of trends and recommends corrective action plans if needed. Ensures program compliance with corporate, departmental and client policies and procedures including SOPs and applicable health authority regulations (e.g. FDA, EMEA), as <br>well as standard inquiry management and documentation practices. Acts as a resource and mentor for operations and quality team members. Often serves as the primary liaison with the clients for training or quality topics.<br> <br>Essential Functions and Other Job Information: <br>&bull; Schedules, develops and delivers training courses and content for all staff <br>members. Conducts product or disease state training for staff members as <br>required.<br>&bull; Monitors effectiveness of training and observes training sessions, trends and <br>assesses impact in employee performance. Manages training modification and <br>improvements to optimize results.<br>&bull; Integrates training with the client while negotiating organizational differences in culture, management structure and staffing. Liaises with the client, department management and staff for all training related topics. Ensures program training documentation remains in audit-ready status.<br>&bull; Manages or leads call and documentation review of staff members' work and <br>ensures accuracy and completeness of information provided, including clinical <br>content. Ensures program consistency relative to compliance with the <br>organization and client policies/procedures. <br>&bull; Evaluates quality trends across the program and provides recommendations and follow up for corrective actions to the client and/or management team. Tracks and documents Quality Events. Develops and implements continuous <br>improvement initiatives based on gaps and trends identified.<br>&bull; Collaborates with corporate quality to oversee program-related audits.<br>&bull; Provides training, coaching and mentoring to team members.<br>&bull; Often participates in or leads departmental projects and initiatives.<br>Job Complexity Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.<br>Job Knowledge Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau.<br> <br> <b>Supervision Received:</b> <br>Determines methods and procedures on new assignments and may coordinate <br>activities of other personnel (i.e., Team Lead). Exercises judgment in selecting <br>methods, techniques and evaluation criteria for obtaining results.<br>Business Frequent contacts with internal personnel and outside customer representatives at Relationships various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise.<br> <br> <b>Education and Experience:</b> <br> <br>Bachelor's degree in Pharmacy or equivalent and relevant formal academic / vocational qualification<br> <br>PharmD degree is highly preferred for this client<br> <br>Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).<br> <br>1 year of experience may be substituted in lieu of education<br> <br>Medical Communications experience is preferred<br> <br>An active NC pharmacist license is required<br> <br>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. <br> <br> <b>Knowledge, Skills and Abilities: </b> <br>&bull; Comprehensive understanding of applicable health authority (e.g. FDA, EMA) or local regulations<br>&bull; Strong knowledge of drugs and drug information<br>&bull; Mastery of document review and ability to lead complex clinical discussions and provide clear and concise feedback<br>&bull; Excellent organizational, time management and strong project management skills<br>&bull; Strong attention to detail and ability to multi-task<br>&bull; Effective verbal and written communication skills<br>&bull; Excellent problem solving skills<br>&bull; Strong computer skills including Microsoft Office<br>&bull; Skillful training and mentoring skills<br>&bull; Excellent language skills (comprehension, speaking, reading and writing) must be demonstrated if the position requires languages other than English<br>&bull; Ability to work and lead in a team environment and/or independently as needed<br> <br>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.<br> <br>Apply today! http://jobs.thermofisher.com 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.<br> <br>Accessibility/Disability Access:<br> <br>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.<br> <br>*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.<img src="https://counter.adcourier.com/YmJnZW5lcmljLjg3NjA2LjEyNTI0QHZlZHBjb21wLmFwbGl0cmFrLmNvbQ.gif">