Client Portfolio Manager, Quality Assurance

Location: 

Baltimore, MD, US, 21230


 

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.

I.    JOB SUMMARY 

This position is responsible to provide a bridge between Emergent site quality and the clients. The QA Client Services manager works in collaboration with Site QA, Project managers the 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 Quality Client Services manager is also responsible for hosting client audits on site, as well as coordinating and tracking the responses for any issues raised during the client audit. 

 

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 a team of specialists to support client services, ensuring personnel development, training, consistency and managing distribution of workload as necessary.
•    Develop and coach direct reports to achieve goals based on corporate objectives and 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.
•    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.
•    Facilitates communication between client and Emergent, on whatever issues are necessary to ensure product supply for client.
•    Hosts clients during on-site or remote visits and / or audits.
•    Manages and oversees Emergent’s 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.
•    Manages the development of these employees, 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.
•    Promptly notify line management & Quality leadership of potential issues or problems.
•    Conduct personnel interviews, performance reviews, develop and administer enhancement plans, follow-up on personnel issues, and conduct terminations when necessary.
•    Share best practices across functional units.
•    Oversee 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.
•    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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Baltimore