Global Project Quality Senior Associate

Work Schedule

Environmental Conditions

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)