Manager, Quality Assurance
ViaCyte, Inc., a leader in the emerging field of regenerative medicine, is a private, venture-capital backed company headquartered in San Diego, California, focused on profoundly improving the way patients with diabetes are treated. For more information on ViaCyte, please visit www.viacyte.com and connect with ViaCyte on Twitter and Facebook.
With little supervision, incumbent shall utilize their Quality Assurance or Quality Engineering experience in the medical device and/or pharmaceutical industry to support the Quality Management System for a complex combination product while ensuring compliance with both medical device and biologic product regulations and ISO 13485 standards.
1. Develop and implement a robust Supplier Quality program that includes; supplier evaluations, establishment of Supplier Quality agreements, and performance of external audits.
2. Manage other employees as required.
3. Perform internal auditing to comply with FDA and ISO 13485 requirements. Maintain inspection readiness.
4. Implement risk management activities for the QMS, including material, supplier, and process risk assessments.
5. Throughout the course of all job activities, maintain accurate records and documentation required to support regulatory submissions and comply with regulatory requirements and the QMS.
Bachelor’s degree and a minimum of seven years of experience in Quality Assurance, Pharmaceutical, medical device, or biologics experience required. Combination Product experience preferred.
- You are an ideal candidate if you are self-motivated, detail-oriented, and have demonstrated success with managing multiple priorities. Flexibility to respond to changing priorities required.
- Extensive knowledge of US and European medical device regulatory requirements. Experience with ISO 13485 requirements. Extensive experience with US, Canadian and EU GMP requirements.
- Experience working with combination products desired.
- Experience in late clinical development/commercial phase QMS desired.
- Experience in Supplier Quality in later clinical stages desired.
- Supplier auditing experience required.
- Must be skilled in Microsoft Office, including Word and Excel. PowerPoint experience is helpful.
- Strong verbal and written communication skills are required.
Our dynamic workplace is attractive to those who are self-motivated and resourceful. You will be expected to set priorities within your job scope and to meet critical deadlines. Flexibility to handle rapidly changing objectives and timelines is essential.
For submission by e-mail, attach your resume and cover letter as a Word or PDF file. In the Subject line, reference Job Code 2019-4 and your full name. Send through BioSpace portal. Our mailing address: ViaCyte, Inc., 3550 General Atomics Court B2-503, San Diego, California, 92121.
It is the policy of ViaCyte to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, ViaCyte will provide reasonable accommodations for qualified individuals with disabilities.
ViaCyte’s goal is to increase representation of women, people of color, veterans and individuals with disabilities. Our programs are designed to comply with all applicable federal, state and local laws, directives and regulations and cover all human resource actions including employment, compensation, benefits, training, education, promotions and social/recre