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 all Quality activities at the site, including QA, QC and quality systems. The plant is a sterile fill-finish site for Emergent products and multiple CDMO customers, requiring the Senior Director of Quality to productively engage with a wide range of internal and external stakeholders. The position reports to the Vice President of Quality Operations.
- Ensure compliance with applicable internal and external regulations, standards, policies and procedures
- Align internal processes and metrics to enable delivery of quality product
- Allocate resources to achieve critical business goals and maintain robust quality oversight and systems
- Drive interactions and alignment of quality standards with CDMO customers to support compliance and lot release
- Maintain effective working relationships with all customers (internal and external) and government agencies (e.g., FDA, BARDA)
- Focus on talent development, both within the site Quality organization, within the entire plant and across the Emergent network
- Define the annual department budget in coordination with the site leader, including expenses and headcount
- Ensure the Quality organization is fully integrated into the site and that interfaces with other teams are effective
- Contribute to the Corporate Quality function, including providing input into Quality standards, processes and other activities.
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
- 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, with a focus on aseptic fill/finish operations.
- Position requires a minimum of 15 years of experience in biopharmaceutical/vaccine companies; experience in gene therapy and/or CDMO operations a benefit.
- 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.
- Proven experience in driving cross-functional teamwork within the overall Quality Dept. and between other departments and key stakeholders
- 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.
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.