Senior Director, Quality
Posted on Apr 6, 2021 by Emergent BioSolutions
The Senior Director of Quality is responsible for managing all Quality activities at one or more Emergent sites, eg, Baltimore Bayview, Camden, Canton, Gaithersburg, Hattiesburg, Lansing, Rockville, and Winnipeg.
Quality Organizations at each site location(s) report directly to the Sr. Director of Quality. This position is responsible for the promotion of quality awareness and continuous improvement at the site. The Sr. 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 Sr. 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. He/She will be responsible for a multi-product, multi-host environment and will need to be skilled in the design and execution of segregation and changeover controls between hosts and platforms.
Quality responsibilities within the scope of this job include the following
Additional responsibilities include
Provide leadership and strategic direction to the specified quality site(s)
Develop staff to enhance capacity and ensure continuity of the Quality function
Ensure the proper interface of the quality function to product development, manufacturing, engineering/maintenance, and other areas as required
Establish strong relationships with internal and external customers-to build, enhance and ensure quality awareness.
Collaborate with all departments to ensure that quality standards and GxP compliance are met and maintained.
Develop and monitor appropriate metrics to track quality and process improvement.
Develop 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 general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
BS degree in (Biological) Science, Engineering, or Operations Management; Advanced Degree (s) preferred
Position requires a seasoned Quality Assurance professional with a minimum of 15 years of experience in biopharmaceutical/vaccine companies
Experience in a multi-product, multi-host environment and will need to be skilled in the design and execution of segregation and changeover controls between hosts and platforms
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.
This position requires vaccination against different viruses including Vaccinia virus and Japanese Encephalitis virus