Thermo Fisher Scientific

Compensation

Full Description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description We are currently seeking a remote-based Associate focused on Quality Assurance for Global Projects to join our team. As the sole supplier responsible for delivering all AxMPs and Commercial IMPs for a global project, you will have the opportunity to collaborate with key customers and make a significant impact on approximately 150 Clinical Trials across approximately 70 countries. In this position, you will have a vital role in ensuring the successful implementation of our global sourcing projects. Your contributions will support our mission to enhance global health, cleanliness, and safety. Collaborate closely with the Global Project QA Manager and extended team daily to assist with sourcing strategy for the project, considering both local and global regulatory duties. Serve as the coordinator for strategic and key operational client-related QA communication across multiple sites. Ensure release documentation (certificates, release documentation) is prepared, verified and shared with applicable parties promptly to ensure project timelines are met. Ensure all project documentation is current and accessible to key partners Support situations involving market shortages and country-related challenges, ensuring quick resolution. Support the timely handling of complaints or recalls on multiple sites to ensure client expectations are met. Report or capture important metrics as required. Collaborate with the CRG for AxMP labeling. Ensure key internal team is advised of significant customer relationship issues, needs or developments. Other duties, as assigned to meet business needs. Keys to Success: To excel in this role, you will need: Broad knowledge of GMPs (e.g.: EU, FDA, APJ) QA/regulatory compliance experience in the pharmaceutical, chemical, medical device, or biotech industry. Knowledge of commercial medication sourcing and global labeling requirements for AxMPs and IMPs. Good understanding of global customs requirements and RA submission strategies. Demonstrated ability to lead and work collaboratively with diverse groups. Excellent problem-solving and prioritization abilities to overcome obstacles and achieve key outcomes. The capability to handle competing priorities and adapt to constantly evolving customer requirements. Education Bachelor's Degree, preferably in a scientific field. Experience As mentioned above Knowledge, Skills, Abilities Good knowledge of global supply chain strategies. Good decision-making and negotiation skills. Ability to evaluate potential risks and recommend process improvements. Excellent written and oral communication skills. Ability to prioritize workload and meet customer needs. Remote Office Work environment, Monday-Friday, 8:00 AM- 5:00 PM (additional hours as necessary) Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.