We go where others wont, 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.

I. JOB SUMMARY

This position serves as liaison between Emergent site quality and the clients. The Quality Assurance (QA) Client Services manager works in collaboration with Site Quality, Project managers, technical SMEs, and the CDMO business unit to ensure efficient and transparent client communications and to facilitate the interaction with the customer for any quality or regulatory related questions, requests, issues, or escalations.
The QA Client Services Manager is the face of Emergent Quality interacting with external clients. This role requires the knowledge of cGMP manufacturing, regulations, industry guidances, and have an established network to successfully manage client expectations.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Works to achieve goals based on corporate objectives and results by optimizing resources and building team effectiveness.
Demonstrates accountability and promotes company core values through working with the client to overcome challenges to key deliverables.
Proactively manage communication and facilitate resolution of quality and compliance related product concerns between Emergent and the client.
Act as Quality advocate and single point of contact for site and CDMO business units with regards to a particular set of clients.
Acts as primary point of contact for client discussions regarding any quality concerns at the site, including the management of Quality Agreements, providing timely responses to quality-related client requests, and providing client requested materials to support regulatory concerns.
Facilitates communication between client and Emergent on all quality issues necessary to ensure product supply for client.
Provides input to Emergents audit / visit responses and quality commitments with the client.
Ensures coordination with supply chain, CDMO business unit, manufacturing, project management and site quality with regards to quality issues.
Collaborate and communicate with other functional areas to promote understanding and achieve strategic objectives.
Promptly notify line management & Quality leadership of potential issues or problems.
Share best practices across functional units.

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 managements assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
B.S / B.A. degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry.
8 years cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial
Previous experience working with FDA/ EU and participating in regulatory agency inspections preferred.
Candidate must exhibit excellent interpersonal and collaborative / facilitative skills
Very strong oral and written communication skills
Ability to work independently and in a team setting with minimal supervision
Ability to make sound decisions regarding compliance-related issues with minimal supervision
Strong Leadership, high level of personal/departmental accountability and responsibility

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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.