Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The VP of Quality Site Operations is responsible for leading quality activities at multiple Emergent manufacturing sites. This position has several direct reports at the Sr. Director-level / Head of Site Quality who each have oversight of QA Operations, Quality Control, and Quality Systems at the site level. This role reports directly to the Executive Vice President, Chief Quality & Compliance Officer and will sit on the Quality and Compliance Leadership Team.
The position provides strategic direction and oversight for quality across multiple sites. Key to the role is ensuring consistency of quality decision-making, aligned with corporate quality standards and the expectations of the Chief Quality Officer. The position will substantially strengthen quality systems, determining the appropriate infrastructure and resources required to meet business demands. A strong collaborative partnership with the VP, Enterprise Quality Systems and Compliance will be essential. The role works with and through the Heads of Site Quality to accomplish these goals.
This role maintains a comprehensive and contemporary understanding of GMP requirements for manufacturing relevant to the plants in scope. The role will be responsible for quality oversight of both Emergent and/ or CDMO products.
The VP serves as a leader, mentor and coach to Quality management , modeling behaviors and leadership aligned with Emergent company values and collaborates across a wide range of internal and external stakeholders. This role will work very closely with the VP, Enterprise Global Quality and Compliance to ensure adherence to global standards and compliance.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• In alignment with Global Quality objectives, define strategic direction and quality objectives for Manufacturing Sites
• Ensure sites are operating in an overall state of control through consistent and continuous engagement with local site leadership on
o Quality issue escalation and resolution
o Use of relevant metrics to drive continuous improvement in processes and systems
o Identification and mitigation of quality risks
o Development of competencies and a culture of quality
• Interface with numerous internal and external stakeholders, including contract partners, product development, manufacturing, engineering/maintenance, regulatory affairs, and other areas as required
• May represent Quality on a Business Unit team
• Determine organizational structure and headcount requirements to effectively staff the quality functions strategically and prospectively, working with quality site leaders, to ensure the appropriate level of quality support
• Provide subject matter expertise for resolution of multi-variant problems
• Other duties may be assigned
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 job description 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 leader with a minimum of 15 years of experience in biopharmaceutical/vaccine companies, including 10+ years of quality decision-making experience
• Must have a track record of success and a broad understanding of contemporary quality processes as they apply to GMP manufacturing in a world-class biopharmaceutical manufacturing organization
• Ability to collaborate successfully and work through others
• Must have technical competence and knowledge relevant to quality systems, quality assurance, laboratory and GMP manufacturing
• Proven ability to successfully establish and manage Quality staff across multiple groups
• Has an excellent understanding of Quality requirements in both the US and EU with extensive knowledge of GMP regulations
• Direct experience interacting with US and international regulatory authorities
• Strong management and interpersonal/communication skills and the ability to negotiate and collaborate effectively with a variety of functions and personnel including external customers, medical, scientific, commercial and operational staff
• Experience in development of an organizational culture that promotes and sustains quality as an element of superior business performance
• Proven ability to be agile and succeed in a fast-paced environment
• 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.