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.
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Reports To
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Chief Executive Officer (CEO)
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Direct Reports
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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
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Location
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Bend, OR
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Employment Status
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Full-Time, Executive Leadership, Exempt
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Areas of Emphasis
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Clinical & Commercial GMP Manufacturing, Oral Solid Dose Products (Tablets, Capsules, Sachets), Spray Drying & Particle Engineering, Quality Systems, Regulatory Compliance
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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
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|
Areas of Emphasis
|
Clinical & Commercial GMP Manufacturing, Oral Solid Dose Products (Tablets, Capsules, Sachets), Spray Drying & Particle Engineering, Quality Systems, Regulatory Compliance
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Serán BioScience is searching for an experienced leader within pharmaceutical manufacturing to lead and support the Quality organization to continue to improve quality systems and compliance. The Vice President of Quality plays a pivotal role in ensuring the highest standards of quality and compliance within pharmaceutical operations to establish trust with company stakeholders and clients. Emphasizing adherence to GMP regulations, VP of Quality will lead the Quality Assurance and Quality Control teams and collaborate with cross-functional departments to drive continuous improvement initiatives. Experience preparing and leading successful regulatory audits is required. Preference will be given to those who have direct experience leading Quality operations specific to Serán's oral solid dosage manufacturing capabilities who have a strong desire to continue to expand the integrity and capabilities of the Quality teams towards future commercial manufacturing capabilities.
Key Responsibilities
Quality Strategy & Governance
Qualifications
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
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.
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.