Vice President of Quality at Serán BioScience – Bend, Oregon
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About This Position
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 |
Quality Strategy & Governance
- Serve as the strategic quality leader, establishing and communicating quality objectives and expectations across all departments
- Oversee all aspects of the Quality Management System (QMS), ensuring compliance with GMP and applicable regulatory requirements
- Develop, implement, and maintain an enterprise-wide Quality Strategy supporting manufacturing, testing, release, and lifecycle management of pharmaceutical products
- Identify and monitor Key Quality Indicators (KQIs) and Key Risk Indicators (KRIs), including trending and escalation mechanisms
- Lead deviation management, CAPA, change control, complaint handling, and management review processes.
- Conduct risk assessments and implement proactive mitigation strategies to prevent quality events and non-conformances
- Lead and support regulatory agency inspections and customer audits, ensuring inspection readiness and effective response execution
- Oversee compliance with FDA, EMA, and global regulatory authority requirements within a GXP framework
People Leadership & Organizational Development
- Provide leadership to Quality Assurance and Quality Control teams, fostering a high-performance, GMP-compliant culture
- Recruit, interview, hire, train, and develop quality staff; provide coaching, performance evaluations, and corrective action as necessary
- Develop organizational goals, succession plans, and capability-building initiatives aligned with company strategy
- Collaborate with Product & Process Development, Manufacturing Operations, Facilities Engineering, Supply Chain, and Environmental Health & Safety to embed quality across the product lifecycle
- Ensure seamless integration of quality processes during technology transfer, scale-up, and commercial manufacturing
- Develop and administer departmental budgets, resource plans, and performance requirements for Quality Assurance and Quality Control functions
- Monitor KPIs to measure the effectiveness and efficiency of quality programs and improvement initiatives
- Foster a culture of accountability, innovation, continuous improvement, and client-centricity across the organization
- Participates in senior leadership team meetings and in strategic annual planning, including setting objectives and strategies as well as takes accountability for implementation and results
Education
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or a related technical discipline (required)
- Master’s degree (MBA, MS, or equivalent) strongly preferred
Experience
- Minimum 15 years of progressive leadership experience in pharmaceutical Quality environment and/or CDMO environments
- Minimum 10 years in a leadership role (Director or above) with combined responsibility for commercial and clincial functions
- Familiarity with spray drying technology for pharmaceutical applications (amorphous solid dispersions, bioavailability enhancement, particle engineering, inhalation)
- Deep knowledge of solid oral dosage form manufacturing, including blending, granulation, compression, coating, and encapsulation processes
Technical Competencies
- Expert understanding of cGMP requirements, ICH guidelines, and regulatory expectations for pharmaceutical manufacturing
- Expert knowledge of the operational process, SOPs (Standard Operating Procedures), and cGMPs (current Good Manufacturing Processes) and the reason for their existence
- Extensive knowledge of FDA cGMP guidelines and regulations as well as global regulatory knowledge is required (E.g., MHRA / EMEA)
Key Leadership Competencies
- Executive presence and credibility with pharmaceutical industry stakeholders, investors, and board members
- Strong GMP and regulatory acumen balanced with deep technical and operational fluency
- Results-driven mindset with a bias toward action, accountability, and measurable outcomes
- Collaborative leadership style that breaks down silos between Quality and manufacturing teams
Compensation & Benefits
This is a senior executive position offering a highly competitive compensation package, including base salary, annual performance bonus, long-term incentive plan, and comprehensive health and retirement benefits.