Sr. Manager, Site Quality
Sr. Manager, Site Quality
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Job Description
Work Schedule
First Shift (Days)Environmental Conditions
WarehouseJob Description
At Thermo Fisher Scientific youll 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 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 Site Quality Manager is responsible for ensuring that products received & distributed are released in accordance with company policies and procedures. Plan develop and implement systems and procedures to improve the operating quality and efficiency of the site. Oversees the independent quality data review of all required validations and outputs as required by the Quality Management System. Position will work closely with the site leaders to troubleshoot errors and provide proactive process improvement. 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. (No more than 2-3 sentences)
A day in the Life:
- Develop and enhance all aspects of the Quality Management System from strategy to hands-on implementation on topics such as Distribution Quality Assurance auditing document management & revision CAPA resolution Change Control Discrepant Material and Risk Management in order to meet the site goals and metrics.
- 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 CAPAs 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.
Keys to Success:
- Bachelors Degree or equivalent experience in a technical/scientific field e.g. engineering chemistry biology quality or mathematics preferred.
- Minimum of 5 years experience working in an ISO (9001 or 13485 preferred) and/or TRS 996 WHO Annex 6 Good Distribution Practices (GDP) environment.
- Minimum of 3 years of experience as a people leader.
- Ability to travel and work in a laboratory warehouse or manufacturing environment.
- Experience with Quality Systems (CAPA internal audit complaint management documentation management among others) Six Sigma Lean Practical Process Improvement etc.
- Experience is using Quality Management System Software MasterControl preferred
- Must have understanding of validation calibration preventive maintenance electronic records among others.
- Skilled at root cause analysis and problem solving with a results orientation.
- Excellent oral and written communication skills.
- Demonstrated experience with customers suppliers and senior management.
- Experienced internal and external auditor lead auditor experience preferred.
- Ability to travel 25% of the time.
Benefits
We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!
Required Experience:
Manager
Employment Type
Full-Time
