Sr Director, Quality

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

The Senior Director of Quality is responsible for managing all Quality activities at Emergent’s Canton site and is a member of the site leadership team.

ESSENTIAL FUNCTIONS
Reporting to the VP, Quality Operations, the Sr. Director, Quality (Canton) is directly responsible for all Quality functions at the site.  This position is responsible for the promotion of a culture of quality 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 Canton site. They will ensure that internal processes and metrics are aligned to create a high level of product quality and consistency. They will substantially 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. 

Quality responsibilities within the scope of this job include the following: 

• Quality Assurance
• Quality Control
• GxP Compliance
• GxP Training
• Validation QA
• Document Control

Additional responsibilities include: 

• Provide leadership and strategic direction to the quality unit.
• 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 professional with a minimum of 15 years of experience in biopharmaceutical/vaccine companies and a minimum of 10 years of leadership experience.
• Experience in bulk drug substance and finished drug product manufacturing. 
• 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.
   

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.