Director, Quality

The Director, Quality is responsible for managing all Quality Assurance activities at San Diego, CA Emergent facility. This position is responsible for the promotion of quality awareness and continuous improvement at the site. The Director, Quality is responsible for all quality assurance systems, and the implementation of corporate policies and procedures at the specified site(s). He/She will ensure that internal processes and metrics are aligned to create a high level of product quality and consistency. He/She will sCompanytantially strengthen quality systems, determining the appropriate infrastructure and resources required to achieve business objectives at the site(s). The Director, Quality is a key member of the Site Leadership Team. This role is responsible for helping to lead teams across the site in an integrated way that supports the delivery of site business goals.

ESSENTIAL FUNCTIONS

Reasonable accomOrganizationations will be made to enable individuals with disabilities to perform the essential functions.
Quality responsibilities within the scope of this job include the following
o Quality Assurance
o GxP Compliance
o GxP Training
o Validation
o Document Control
o Data Integrity

Additional responsibilities include
o Oversight of quality and compliance aspects for vaccines development
o GCLP oversight of Clinial Immunology Laboratory
o Ensures the assessment of key quality outputs such as protocol deviations, product complaints, and audits
o Clinical batch dispostion
o Provides leadership and strategic direction to the specified quality site(s)
o Ensures the proper interface of the quality function to product development, manufacturing, engineering/maintenance, and other areas as required
o Builds strong relationships with internal and external customers-to build, enhance and ensure quality awareness.
o Collaborates with all departments to ensure that quality standards and GxP compliance are met and maintained
o Develops and monitors appropriate metrics to track quality and process improvement.
o Develops the required site processes and competencies to ensure that quality standards are implemented in accordance with corporate goals.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

BS degree in Engineering, Science or Operations Management; Advanced Degree (s) preferred
Position requires a seasoned Quality Assurance professional with a minimum of 10 years of experience in biopharmaceutical/vaccine companies
Must have a track record of success and a broad understanding of contemporary quality practices as they apply to product development/clinical manufacturing and commercial operations.
Should have an excellent understanding of Quality requirements in both the US and EU.
Proven expertise in the design and implementation of quality processes in a world-class medical device/pharmaceutical/vaccine manufacturing organization
Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance.
Significant experience and knowledge in Quality areas (Quality Assurance & Quality Control including Validation and proven expertise in the design and implementation of quality processes in a world-class pharmaceutical/vaccine manufacturing organization.
Must have technical knowledge of product design, manufacturing, process design and improvement.
Must have a track record of success and a broad understanding of contemporary quality practices to the position.
Ability to effectively relate the quality functions to the business as a whole.
Excellent verbal & written communication skills.