Director, Client Relations QA

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.

I.    JOB SUMMARY 

Reporting to the VP of Quality Operations, this position is responsible to provide a Quality Leadership and a bridge between Emergent site quality, operations, and clients. The Director, Client Relations Quality Assurance, The Director, Client Relations, Quality Assurance is the face of Emergent Quality interacting with external clients, and works in collaboration with Site QA, Client Portfolio Relation Managers and Technical Product Leaders to ensure compliant, effective, efficient, and transparent quality support.  This individual is responsible for building, executing, and maintaining how the quality function operates within the CDMO spaces across the Maryland area and leading the required activities needed to support compliance and quality supply to clients.  The Director, Quality Services facilitates/communicates quality represented responses and activities with the customer for any quality or regulatory related questions, requests, issues, or escalations. The Director, Client Relations, Quality Assurance is also responsible for ensuring the site has proper support for hosting client audits, which includes supporting these audits in different capacities based upon need, as well as ensuring the coordination and tracking for associated responses identified during the client audit. 

This role requires the knowledge of cGMP manufacturing, regulations, industry guidance’s, and have an established network to successfully lead this organization. 

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

•    Leads a team in the safe and compliant execution of their activities.
•    Manages the development of Quality Client team, while recognizing contributions, mitigating conflict and communication problems, planning, and facilitating team meetings, using a skills-based approach to select personnel for DR resolution, and motivating members of the functional areas.
•    Develops, mentors, and coaches’ direct reports in achieving goals based on corporate objectives and CDMO objectives, as well as results by optimizing resources and building team effectiveness.
•    Demonstrates accountability and promotes company core values through leading the group in overcoming challenges to key deliverables.
•    Establishes Quality KPI’s to track, monitor, trend, and to report on the progress of activities supporting CDMO work.
•    Proactively manages communication in partnership with the Client Portfolio Relations Manager to facilitate compliance related product concerns.
•    Acts as quality advocate for site and CDMO business units 
•    Leads team of Quality Clients individuals, who act as primary point of contact for client discussions regarding quality and compliance.
•    Facilitates communication within Client Portfolio team on whatever issues are necessary to ensure product supply for client.
•    Responsible for ensuring clients have the appropriate quality host during on-site or remote visits.
•    Manages and oversees Emergent client visit responses and quality commitments with the client.
•    Builds, executes, and maintains the proper measurements/metrics that support and facilitate client meetings and interactions. 
•    Ensures coordination with supply chain, CDMO business unit, manufacturing, project management and site quality with regards to quality issues.
•    Collaborates and communicates with other functional areas to promote understanding and achieve strategic objectives.
•    Escalates potential issues to Sr Director of Site Quality and VP of Quality Operations 
•    Conduct personnel interviews, performance reviews, develop and administer enhancement plans, follow-up on personnel issues, and conduct terminations when necessary.
•    Shares best practices across functional units.
•    Oversees the training, qualification, and requalification of personnel.

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. 

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.
•    10 years cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial
•    Previous experience interacting with FDA/ EU and participating in regulatory agency inspections preferred.
•    Prior experience working/leading relationships with external parties
•    Experience leading teams
•    Experience with negotiating and implementing Quality Agreement (writing, review, approving, and collaborating).
•    Candidate must exhibit excellent interpersonal and collaborative / facilitative skills
•    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
•    Quality functional experience working with clients or CDMOs.
•    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.