Serán BioScience, LLC, a leading Contract Development and Manufacturing Organization (CDMO), is seeking a Vice President of Quality to lead the clinical and commercial quality teams. In addition to sustaining successful early-phase drug deliveries, Serán is building a state-of-the-art facility that will be dedicated to Commercial manufacturing of novel medicines along with associated support facilities, warehouses, and laboratories. The VP of Quality is responsible for defining and executing the enterprise Quality Strategy, overseeing the Quality Management System (QMS), and ensuring adherence to GMP, GXP, FDA, EMA, and other global regulatory standards. This leader fosters a culture of accountability, continuous improvement, and proactive risk management while supporting clinical and commercial manufacturing growth. The VP of Quality will be responsible for leading the established teams supporting clinical operations while developing the organizations to execute quality functions for Commercial Manufacturing. The VP of Quality will work with the executive management team to ensure that quality excellence transpires from clinical to commercial business instilling confidence that Serán is a trusted partner to achieve manufacturing excellence and scalability for end-to-end service from early development through commercial-scale supply.

 

Reports To	Chief Executive Officer (CEO)
Direct Reports	Director of Quality Control and Analytical Services, Director of Quality Assurance, Director of Commercial Quality Control, Director of Commercial Quality Assurance, Director of Quality Engineering & Computer System Assurance
Location	Bend, OR
Employment Status	Full-Time, Executive Leadership, Exempt
Areas of Emphasis	Clinical & Commercial GMP Manufacturing, Oral Solid Dose Products (Tablets, Capsules, Sachets), Spray Drying & Particle Engineering, Quality Systems, Regulatory Compliance

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