**Work Schedule** First Shift (Days) **Environmental Conditions** Warehouse **Job Description** 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 – To enable 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. Alongside clinical research through our PPD® clinical research portfolio, our work in accelerated enrollment solutions optimizes each step of the patient journey in clinical trials, such as securing sites and recruiting patients, allowing for more patients to participate in clinical research. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on – now and in the future. **Location/Division Specific Information** This role supports the new, state of the art, Independence Kentucky Distribution Center and future expansion into other GDP locations. Responsibilities include management of the Quality Management System (QMS), leadership and partnership of the site Quality Processes, Change Control, Risk Assessments & Data Integrity. **Discover Impactful Work:** The Sr Distribution Site Quality Manager is responsible for ensuring that products received & distributed are released in accordance with company policies and procedures. This position is a working leadership role responsible for site quality programs as well as the day-to-day responsibilities within the Quality Management System processes. **What will you do:** + Develop and enhance all aspects of the Quality Management System from strategy to hands-on implementation in order to meet the site goals and metrics. (topics include but not limited to: Distribution Quality Assurance, auditing, document management & revision, CAPA resolution, Change Control, Discrepant Material and Risk Management) + Partner with Customers and Business Partners to assist with and follows-up on non-conformances, investigations, complaints, etc. + Assures that issues are resolved in a timely manner and corrective actions are implemented and monitor effectiveness to prevent recurrence. + Assist with internal, regulatory, and customer audits. + Drive a culture of continuous improvement, problem solving & education across the Distribution Quality function, including a focus on reducing customer complaints & external errors. + Provide Quality guidance to process-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs. + Apply and guarantee that the MasterControl system is used at the site for Risk Assessment, Deviations, CAPA’s, Issue Reviews & guarantee robust corrective/preventive actions are established and effective in a timely manner working with multi-functional teams + Partner with site resources to ensure that new employees have been properly onboarded and assigned applicable training and ensure that ongoing training assignment is accurate. + Maintain solid understanding of Regulatory and Quality System requirements (ISO 9001, ISO 13485 / FDA CFR & TRS 996 WHO Annex 6 Good Distribution Practices. + Other responsibilities as assigned. **How will you get here:** **Education:** + Bachelor’s degree in a technical/scientific field required (engineering, chemistry, biology, quality or mathematics preferred) **Experience:** + 5+ years experience working in an ISO (9001 or 13485 preferred) and/or TRS 996 WHO Annex 6 Good Distribution Practices (GDP) environment. + (5+) years of experience within distribution/supply chain + 3+ years of people leadership experience required + Experience with Quality Systems, (CAPA, internal audit, complaint management, documentation management etc.) Six Sigma, Lean, Practical Process Improvement, etc. + Experience is using Quality Management System Software required (MasterControl preferred) + Prior internal/external auditor or lead auditor experience preferred. **Knowledge, Skills and Abilities:** + Understanding of validation, calibration, preventive maintenance, electronic records, among others required. + Skilled at root cause analysis and problem solving with results orientation. + Ability to travel and work in a laboratory, warehouse or manufacturing environment. + Strong leadership and interpersonal skills to effectively manage and motivate a team, build relationships with employees, peers, and management, and prioritize customer satisfaction. + Demonstrated ability to lead through ambiguity and change. + Excellent oral and written communication skills. + Demonstrated experience with customers, suppliers, and senior management. + Ability to travel 25% of the time. **What We Offer** **Competitive Salary:** + Pay rate based on experience + Annual performance-based bonus + Annual merit performance-based increase **Excellent Benefits!** + Medical, Dental, & Vision benefits-effective Day 1 + Paid Time Off (120 hours per year) + Designated Paid Holidays + 401K Company Match up to 6% + Tuition Reimbursement – eligible after 90 days! + Employee Referral Bonus 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 at ThermoFisher Scientific, where diverse experiences, backgrounds and perspectives are valued. 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.