Associate Director of Quality Assurance
4 days ago
Kanvas Biosciences is a pioneering biotechnology company dedicated to unlocking the full potential of the microbiome. Our mission is to harness the power of microbial interactions to develop innovative treatment strategies and improve human health.
Our Values- We attract and retain top talent. Our team is comprised of world-class scientists who share our passion for innovation and excellence. We value integrity, honesty, and dedication, and strive to create a collaborative and supportive environment that fosters growth and success.
- We think creatively. We recognize that the microbiome is a complex and dynamic system, and we approach challenges with a curious and open-minded mindset. We encourage our team members to think outside the box and explore new ideas and approaches.
- We prioritize teamwork. We believe that our collective knowledge and expertise are the keys to success, and we work together to achieve our goals. We support each other, share knowledge and expertise, and celebrate our successes.
- We celebrate diversity. We believe that a diverse and inclusive team is essential to driving innovation and achieving our mission. We welcome individuals from all backgrounds and perspectives, and strive to create a culture that values and respects everyone's contributions.
We are seeking an experienced and dedicated Associate Director of Quality Assurance to join our dynamic team. Reporting to the Head of Regulatory and Quality Assurance, the Associate Director will assist in the quality oversight and management of GxP activities internally and externally with vendors. The ideal candidate will have extensive quality assurance experience within the biotech/pharmaceutical sector, be a fast learner and self-motivator, have the ability to effectively multi-task to meet short deadlines, possess a high level of attention to detail, and thrive in a busy, fast-paced environment.
Key Responsibilities:- Manage the QA oversight of GMP manufacturing vendors, including involvement and review of method validation documentation, stability protocols and reports, GMP drug substance and drug product specifications, GMP drug substance and drug product master and executed batch records, and GMP drug substance and drug product release.
- Maintain the Quality Management System and assist in the development and maintenance of GxP SOPs and electronic systems.
- Review and approve validation protocols, quality agreements, and other technical documents.
- Collaborate with cross-functional teams to address and resolve quality issues promptly.
- Assist in establishing and ongoing management of vendor relationships.
- Oversee the development and implementation of quality assurance policies and procedures to ensure product quality and regulatory compliance.
- Provide quality assurance input for the development and manufacturing of our LBPs products.
- Prepare and present quality reports to senior management.
- Perform other duties as assigned by the Head of Regulatory and Quality Assurance.
We are seeking candidates who have a Bachelor's degree in a scientific discipline and a minimum of 10 years of experience in Quality Assurance within the biotechnology or pharmaceutical industry, with a minimum of 6 years within GMP. The role requires the following experience and key qualifications:
- Experience with an electronic quality management system, ACE Essentials being preferred but not necessary.
- Strong knowledge of FDA, EMA, and ICH guidelines.
- Proven leadership and team management skills.
- Excellent problem-solving and decision-making abilities.
- Ability to manage multiple priorities in a dynamic, fast-paced development environment.
- Strong communication and interpersonal skills.
We expect the candidate filling this position to be physically present at our office to best be an integral part of our team's ongoing research efforts.
At Kanvas, we offer a competitive salary and benefits package that includes full medical, dental, and vision insurance packages for employees and their families, and paid time off.
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