Hi! We're Smartsourcing, looking for a Compliance and Quality Assurance Manager who can work with us full-time and on-site!
Where??? JEG Tower, Archbishop Reyes, Corner Acacia St., Barangay Kamputhaw, Cebu City, Cebu Our partners, a leading preclinical stage gene therapy company focused on neuromuscular junction diseases, is seeking a detail-oriented Compliance and Quality Assurance Manager. This role will ensure compliance with FDA regulations, oversee documentation accuracy, and support their clinical and preclinical programs, including a gene therapy project. The ideal candidate will have a background in quality assurance and project management within biotech or a related field.
Some of the things we expect you to do are to: Regulatory Compliance: Review and ensure all technical documents meet FDA and international standards for gene therapy. Monitor and address compliance with regulatory requirements for manufacturing and clinical documentation. Documentation Oversight: Manage and analyze product specifications, including those for plasma and viral vectors, ensuring compliance and consistency. Organize and maintain documentation repositories for easy access and auditing. Compare and reconcile manufacturing specifications across different scales (e.g., 2L to 50L). Quality Assurance: Identify and document gaps in quality or compliance in existing processes. Draft detailed summaries and quality reports for management and regulatory submission. Collaboration and Support: Work closely with the Program Director, manufacturing teams, and external partners. Facilitate cross-functional meetings to ensure alignment on quality standards and deliverables. Support team training on quality and compliance processes. Continuous Improvement: Identify opportunities for process improvements in document management and compliance workflows. Stay informed of updates in FDA guidelines and ensure internal processes align with evolving standards. We would need you to be or have the following: Minimum requirement: Bachelor's degree in biology, biotechnology, or a Science-related field; or a master's degree. In the absence of a master's degree, significant experience in QA/QC within a pharmaceutical research and development setting is essential for 2-4 years An understanding of FDA regulatory requirements and quality standards is a must! Experience with clinical and preclinical documentation, including manufacturing specifications. Exceptional organizational and analytical skills with keen attention to detail. This person should be a smart, self-motivated individual with a proactive approach to work. Has experience in using project management tools and document control systems. Excellent communication skills for coordinating across teams and stakeholders. Be a part of the Smartsourcing crew ??! Smartsourcing was born with the purpose of changing people's lives. Our goal is not only to make sure businesses grow and succeed but also, that you love where you work and thrive. We recruit, train, and support you and provide great benefits. We take pride in the fact we are an award-winning organisation, hailed as one of the best employers and workplaces in Asia as seen on Great Place to Work and HR Asia.
Here's why we think you'd love working at Smartsourcing… At Smartsourcing, we're all about fostering a positive work environment for you. We're always looking for folks who are unafraid to be their absolute authentic selves because we value diversity and inclusion.
We're proud to be a certified Great Place to Work. We believe that we can expect the best out of you only when you're happy with where you work and what you do. This is why It is so vital for us that you have a healthy work-life balance.
Some of our company perks include: ?? Above-industry salary package ?? Day Shift ?? Fixed weekends off ????? HMO coverage for you and your dependent/s from day one ?? Free lunch every day ? Free coffee every day (latte, americano, or cappuccino) made by our in-house barista ?? Sports wellness clubs including free-diving ??? Subsidized gym membership at Anytime Fitness ?? Travel opportunities to Australia ?? Exclusive discounts in selected restaurants and merchants And so much more!