Associate Director, Quality Systems and Compliance

Serán is seeking an Associate Director, Quality Compliance who will be responsible for leading the Quality Compliance program to ensure ongoing adherence to applicable GxP regulations, client requirements, industry standards, and internal Quality Management System (QMS) requirements. This role serves as the primary owner of inspection readiness, regulatory inspection management, client audit support, internal audit programs, supplier quality oversight, management review, quality metrics, and compliance monitoring activities. This position serves as the independent quality oversight function responsible for evaluating the effectiveness of Quality Management System processes and ensuring sustained compliance with regulatory, client, and internal quality requirements. The Associate Director partners closely with Manufacturing, Quality Control, MSAT, Supply Chain, Regulatory Affairs, Engineering, Validation, and Quality Systems to foster a proactive quality culture and ensure sustainable compliance as the organization advances commercial manufacturing capabilities. This position serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to cGMP compliance oversight. Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon. Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. Benefits Summary: Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance. The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701