Quality Systems, Manager


Rockville, MD, US, 20850


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 Manager, Quality Systems is responsible for management and oversight of personnel and quality systems by networking with internal and external stakeholders to positively influence the compliance health of the company. This is a key role which contributes to the continuous improvement of quality and compliance at the Rockville site.


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


  • Serve as the Subject matter Expert on site Quality Systems and provide guidance and interpretation to internal stakeholders.
  • Manage the generation, execution and technical review of data and documentation, ensuring that they are maintained in compliance with FDA regulations, global regulations, and Emergent internal directives.
  • Lead preparations for internal, external, and other regulatory agency inspections (FDA, EMU, etc.). Manage resolution for both audit and inspection findings.
  • Oversee and manage site’s Quality Risk Management Systems to ensure proper follow up and closure of identified risks. Collaborate with other impacted Emergent’s sites and functions to ensure identified gaps from emerging regulations are addressed.
  • Review and approve compliance documentation such as procedures, contracts, audit reports and quality agreements.
  • Lead and manage the CAPAs, Deviations, Change Controls, Audits and Supplier Quality Management program. Responsible for timely completion of compliance, change controls and CAPA commitments.
  • Develop and implement procedures for compliant and effective Quality Management Systems. Streamline processes and effectively utilize tools and resources to improve site compliance.
  • Establish, track and present Quality Metrics to support Quality Management Review.
  • Participate as Quality Assurance representative on various project teams with impact to compliance and/or the Quality Systems.
  • Support the Quality team during deviation/formal investigations, including participating in root cause analysis activities, document review and verification, determination of corrective/preventive action and assessment of product impact.
  • Maintain current knowledge of industry standards and regulatory requirements.



  • All functions associated with recruitment and hiring process for department
  • Manage employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts.
  • Mentor, train and develop team members.
  • Define resource requirements, plans, and prioritize resources.
  • Conduct personnel interviews, performance reviews, develop and administer development plans, follow-up on personnel issues, and provide feedback to group
  • Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements as applicable
  • Mentor, coach, challenge, and develop team members while serving as a role model of Emergent’s core values
  • Ensure the team effectively collaborates with key internal and external stakeholders, in accordance with our corporate values and practices



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.




  • BA/BS degree, preferably in a life science related discipline, or equivalent work experience.



  • Minimum of 6 years of experience working in an FDA regulated industry including participation in agency inspections.
  • Highly desirable to have minimum of 4 years of management experience.
  • Demonstrated experience leading a staff through mentoring and coaching in support of business needs, evaluating performance and proactive handling of employee relations.
  • Previous experience working with FDA and participating in regulatory agency inspections.
  • Previous experience in management of Quality Systems. Previous experience operating within Quality Systems such as: Deviation, CAPA, and Change Control.



  • Must possess strong cGMP knowledge across Compliance functions.
  • Must have competence of cGMPs, 21CFR, and up to date knowledge of regulatory guidance and expectations.
  • In-depth working knowledge of Veeva Document System and SAP preferred.



  • Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required.
  • Must have SOP, investigation, change control/corrective action, and project protocol writing skills and demonstrated ability to critically evaluate content of such documents.
  • Must have excellent verbal and written communication skills and the ability to successfully manage without authority in a cross-functional matrixed environment.




  • Demonstrated capabilities (e.g., able to translate strategy to action, Effective verbal and/or written communicate at all levels of organization, work effectively in ambiguous situations, ability to multi-task, proven track record of increasing customer base)
  • Must be able to critically evaluate data summaries and conclusions.
  • Must be able to prepare reports for internal metrics and technical content.
  • Ability to exercise judgment within defined practices and policies by selecting methods and techniques for obtaining solutions including strategic CAPA.
  • Ability to work in a team environment as the quality representative with both internal and external customers.
  • Must have strong attention to detail.






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.


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.


  • 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: Washington DC