Vice President, Quality

3 weeks ago

New York, United States IAVI Full time

**Position Description**

**Job Title**:Vice President, Quality
**Location**: New York, NY preferred; Remote-US; Cape Town, South Africa; South Africa Remote; Nairobi, Kenya; Amsterdam, Netherlands; OR United Kingdom Remote
**Reports to**: President & Chief Executive Officer

**Position Summary**:
Are you an experienced Quality Leader, eager to lead the quality function for a dynamic mission-driven organization?

IAVI is seeking a **Vice President, Quality**, to lead and drive quality throughout our dynamic and complex organization. The VP of Quality reports to the CEO and leads and manages across all key quality areas. The VP develops and leads IAVI’s quality strategy, goals and objectives, policies, standards, and procedures as they relate to quality and compliance, ensuring strategic alignment with IAVI vision and strategy. The VP oversees and monitors the direction for all quality activities both internally and externally, as well all quality-related improvement initiatives. The VP is accountable for ensuring IAVI has a robust and effective Quality Management System (QMS) in place.

**Key Responsibilities**:
Organizational Quality Leadership and Culture
- Provide leadership to the development, strengthening and sustaining of a quality culture across IAVI, including the alignment of quality goals and objectives to support IAVI’s strategy and to reflect its values.
- Develop short and long-range organizational quality goals and objectives, policies, consistent with organizational business plans and disseminating the same throughout the quality function.
- Ensure IAVI’s Quality Management System, standards, policies, and processes are fit for purpose, informed by industry best practice, and reviewed for continuous improvement.
- Provide all organizational functions with sound and current quality and compliance direction for all business aspects related to GXPs for internal and external operations.
- Drive functional improvement and transformation of initiatives for quality initiatives throughout the organization, providing technical quality support to improvement and transformation efforts within other functions, being a driver of frequent and consistent of sharing of best practices across the organization.
- Partner within internal functions and project leadership to define target objectives and metrics to ensure proposed systems and processes are feasible, actionable, and aligned with functional standards and project goals.
- Foster a culture of quality within the organization and partners with other members of the LT understand and sponsor IAVI’s quality culture.

Quality Operations
- Oversee the development, implementation, and maintenance of a Quality Management System processes.
- Ensure organizational compliance with current regulatory and company standards of quality.
- Provide oversight, guidance, and ultimate authority for any regulatory health authority inspections that occur for internal operations, including inspection management, response coordination, and driving the organization to completion of relevant corrective actions.
- Partner with external quality functions to ensure clarity in roles and responsibilities, while assuring adherence to GXP compliance and supporting their interaction, alignment or implementation and maintenance of IAVI’s quality standards, processes, and infrastructure.
- Ensure that the QMS includes effective oversight of all external partnerships and outsourced activities.

Leadership of the Quality team
- Provide oversight to all resources working in quality across the organization and builds an understanding of quality responsibilities across the organization.
- Lead and develops the quality team to ensure it continuously evolves to support the needs of the organization.
- Mentor and coach others with specific emphasis on role modeling quality leadership, continuous improvement, and program oversite, metrics, and tracking.

**Education and Work Experience**:

- BS in chemistry, biological/analytical services, or other related scientific fiend is required; Advanced degree (MS or PhD) is highly preferred.
- Has completed specific training in quality and is trained and up-to-date on the latest methodologies to implement, lead and continuously evolve and improve quality systems in product development organizations.
- Minimum of 15 years of industrial experience, including 10 years of experience in in quality functions within the pharmaceutical, biotech, vaccine industry is required.
- Broad experience in quality functions, including clinical, regulatory, laboratory, manufacturing is required.

**Qualifications and Skills**:

- Experience with and knowledge of regulatory health authority laws and regulations is required.
- Vision, self-motivation, as well as exceptional communication and leadership skills.
- Experience leading highly outsourced organizations, with high diversity of partners.
- Experience working in Africa or similar geographies
- Experience hav

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