This job has expired

You will need to login before you can apply for a job.

Sr Director, Quality Regulatory Compliance

Emergent BioSolutions
Gaithersburg, MD
Start date
May 31, 2023

View more

Regulatory, Legal/Compliance, Regulatory Affairs
Required Education
Masters Degree/MBA
Position Type
Full time

Job Details

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 Sr. Director of Regulatory Compliance will oversee the deployment of Emergent BioSolutions Inc. (EBSI) Regulatory Compliance framework across the GxP lifecycle.  The position will manage the activities of the Quality Review Team and manage and maintain the Notification to Management processes, as well as oversee the Recall Program and coordinate any field actions across the GxP enterprise. 

Role will report directly to the Vice President, Enterprise GxP Compliance & Systems.


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

•    Lead annual global Regulatory Compliance planning activities, to drive regulatory compliance and quality across GxPs.
•    Ensure Regulatory Compliance framework processes are established, implemented, audited, and continuously improved.
•    Establish and manage the Quality Review Team ensuring a platform for the voice of impacted stakeholders and ensuring a fully compliant system for documenting relevant quality regulatory compliance decisions.
•    In collaboration with the Sr. Directors of Inspection Readiness and Compliance implement and monitor an effective and efficient Notification to Management Program across the enterprise GxP activities.
•    Maintain global Notification to Management Program and track performance and metrics and ensure appropriate escalation through the site and global quality management review processes.
•    Oversee the Recall Program across the enterprise including oversight of site annual mock recalls.
•    Oversee field actions across the GxP enterprise.

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. 


•    Degree level in Life Sciences and/or Information Systems, Advanced degree and/or MBA an advantage.
•    10-12 years of experience in the Biopharma/Pharmaceutical industry with cross-functional experience in quality regulatory compliance.
•    Excellent leadership, interpersonal, communication, negotiation, and problem-solving skills.
•    Sound understanding of regulated activities, health authority expectations, and GxP.
•    Excellent organizational awareness (e.g., Research & Development, Commercial Manufacturing, interrelationship of departments, business priorities), including significant experience working cross-functionally and in global, cross- cultural teams.
•    Experience developing and executing large-scale organizational change, including change management strategy and planning.
•    Proven ability to understand complex processes/problems and facilitate/coach teams to optimal solutions.
•    Ability to design and implement global business processes/policies with a critical thinking approach and enterprise mindset.
•    Proven experience managing/influencing stakeholders across a broad spectrum of GxP topics.
•    The ideal candidate will have excellent written and oral communication abilities.
•    Extensive experience with industry-standard software applications (Microsoft Word, Excel, PowerPoint). 
•    Ability to effectively maintain a culture of continuous improvement is essential.


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.


Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit Find us on LinkedIn and follow us on Twitter.

Stock Symbol: EBS


Find Us
400 Professional Drive
Suite 400
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert