Quality Management Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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 (AES) 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.

Position Summary:

Serves as the lead and subject matter expert on the operational quality management framework within assigned clinical research sites in the applicable geographic region. Serves as the main site quality management liaison in order to drive and deliver operational quality and process improvement initiatives, ensure quality training and compliance across the geographic area to increase operational quality, efficiency and long-term business success. Provides consultation on operational quality, risk and regulatory and legislative compliance to sites/functional departments.

Key Responsibilities:

• Ensures quality focus and provides support to the site Dyad leaders to establish quality and regulatory compliance within assigned clinical research sites in the applicable geographic region.
• Develop strong relationships and actively liaises cross-functionally at the site level. Acts as the point of contact to cascade information to appropriate sites.
• Maintains SME level knowledge of operational processes and procedures to effectively manage site level quality compliance with SOPs, work instructions and corporate policies within assigned clinical research sites.
• Perform regular site visits, as needed, to develop site-level relationships, perform quality control activities, support investigations, mentor/train staff, prepare for audits, verify CAPA/new process implementation and perform other activities, as required.
• Supports the reporting, processing, follow up, and trending of minor Quality Events within the assigned clinical research sites.
• Supports preparation activities associated with internal and external audits and inspections.
• Identifies Operational Compliance performance metrics and trends on data generated, and provides required metrics reports to management, as appropriate.
• Provides training on functional GCP and other compliance and quality related topics, as required, to improve quality and expertise within the operation of the regional research sites.
• Ensures site compliance with FDA, GxP, and all other applicable regulatory body guidance and international standards.
• Safeguards confidentiality of staff, patient and sponsor matters as required by regional GDPR and Good Clinical Practice expectations.
• Acts as a resource to ensure patient safety and data integrity are at the forefront of all activities through review and interpretations of quality reports (e.g. audit reports inspection output, complaints).
• Works with site dyad leadership to complete monthly key risk indicator tool, identify potential risks, and develop mitigation strategies in line with the business’s risk-based quality management program.
• Complete monthly trending of minor quality events and provide site level reports to applicable management.
  
  

Education Requirements:

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
  
  

Experience:

• Previous applicable experience that provides the knowledge, skills, and abilities to perform the job.
  
  

Knowledge, Skills, Abilities:

• Strong understanding of the audit process, including audit preparation and oversight (regulatory authority and FDA will be advantage).
• Good understanding of theory and techniques in the data and compliance field
• Advanced working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
• In-depth knowledge and understanding of the requirements, best practice and organization of a clinical research site.
• Strong interpersonal skills, including assertiveness, persistence and flexibility.
• Strong written and verbal communication skills
• Effective organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple project
• Proficiency in English and Polish languages