Job DescriptionAt 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.Oversees a QA team responsible for bids, proposals, and budget estimates for billable Good Clinical Practice and Good Manufacturing Practice quality services. Manages and develops staff. Ensures delivery of quality solutions in a collaborative cross-functional environment. Leads process improvement initiatives and communicates with internal operations regarding continuous improvements.
Leads the Pre- and Post-Contract Management team within the PPD Quality and Enterprise Learning
Participates in managing the development of proposals for billable Good Clinical Practice and Good Manufacturing Practice quality services
Serves as a resource and subject matter expert for quality service budgets and for the quality service bidders
Reviews Requests for Proposal (RFPs) and participates in budget strategy meetings
Prepares thorough and accurate written bids, proposals, and budget estimates for submission to clients, collaborating with Finance, Business Development and QA management personnel
Prepares proposal revisions based on feedback/updated information from clients
Participates in the development and/or review of contract modifications related to quality services
Maintains the quality service bid models and implements new models as required by QA Management
Generates and maintains governing process documentation, as well as tracking and reporting on the status of awarded proposals for quality services
Provides oversight, development, and performance management to the QA team to drive performance goals and objectives
Recommends priority of projects and monitors work assignments ensuring adequate resourcing to meet internal and client timelines and provide quality deliverables
Education and Experience :Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).1+ year of leadership responsibilityIn 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.Knowledge, Skills and Abilities : Strong leadership skills and business acumen Ability to effectively mentor and provide direction to staff Knowledge of appropriate regional regulations and applicable global pharmaceutical industry guidelines For Lab QA Management, knowledge of analytical methodologies, instrumentation and method validation required Good verbal and written communication skills Demonstrated proficiency with regulations and guideline interpretation, proper documentation and QA departmental policies and procedures Detail oriented with ability to deal with multiple and changing prioritiesOur 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.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.Accessibility/Disability Access: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.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.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.