1+ months

Director, Global Clinical Quality

Gaithersburg, MD 20877

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.

This position is required to network across all Emergent sites and with external suppliers and stakeholders to oversee and ensure the compliance of clinical and non-clinical studies. The position also requires providing direction and oversight to Emergent staff and consultants, ensuring requirements and schedules are met. This is a key role which directly contributes to the continuous improvement of quality and compliance at all Emergent sites.

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

Lead the Global Clinical Quality function (GCP, GVP, GLP) promoting a culture of quality by collaborating across departments, business areas, and all levels of management to ensure Emergents company objectives are met and Emergent Clinical trials are conducted in accordance with regulations, guidance and industry standards as applicable.
Provide expertise in GCP and GLP compliance interpretation, consultation, training and recommendations to clinical and nonclinical development functions and program teams to proactively identify compliance issues/risks and recommend mitigation
Oversee quality functions related to audits (internal and external) of clinical and non-clinical studies and the pharmacovigilance system
Translate compliance requirements into executable policies and procedures.
Participate in Corporate GxP due diligence activities for acquisition candidates as requested.
Establish and execute compliance strategies that align with business goals and objectives.
Provide corporate support for Regulatory inspection responses updates, consolidating and coordinating the development of global standards and policies as appropriate and necessary.
Serve as Quality lead and approver in authoring or reviewing compliance documentation such as Procedures, Contracts, Audit Reports, and Quality Agreements.
Provide training, guidance, coaching, and mentoring of staff with various experience levels and capabilities to develop new leaders, individual contributors, and technical experts.
Ensure that staffing and budgetary requirements are effectively managed, striving for effective performance through fiscal discretion and talent management.

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.

Bachelors Degree in Biological Science or similar science.
10+ years of pharmaceutical, vaccine or medical device / combination product R&D industry with a minimum of 8 years in hands on cGCP, GVP, GMP and GLP Quality experience with increasing responsibilities (ICH GCP, GLP regulations (21 CFR Part 58 and OECD Principles) and applicable global regulations and guidance for clinical and non-clinical development)
Operational experience (e.g., Clinical Operations, Data Management, etc) an advantage
Highly desirable to have minimum of 8 years of leadership experience; managing, coaching and mentoring others.
Solid working knowledge of FDA, Health Canada and EMA GXP regulations, and including interpretation and application across the GXP disciplines
Preparation, planning, hosting and participating in regulatory agency inspections for GCP and GLP areas
Experience in building GCP and GLP systems and process and establishing and maintaining independent Quality oversight programs
Previous auditing experience and a broad understanding of GXP compliance programs is required.
Advanced knowledge in the conduct and reporting of audits, root cause analysis and the translation of findings into corrective action plans that mitigate risks to study subjects, data integrity and the clinical programs.
Must have skills for the critical assessment of processes, investigations, and project protocols for content that will meet compliance requirements.
Highly desirable to have prior experience with developing and maintaining department budgets.
Must have excellent written and verbal communication skills. The ability to communicate clearly and extemporaneously to a variety of audience types. Must be able to act as representative for the function and develop others to communicate effectively and prepare appropriate updates to senior management and executive management.
Strong judgement, project management and decision-making skills; able to manage multiple projects and demanding timelines
Must be able to critically evaluate data summaries and conclusions.
Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required
This position can be hybrid or full time remote

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.


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



  • Biotechnology
Posted: 2022-03-18 Expires: 2022-08-21

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Director, Global Clinical Quality

Emergent BioSolutions Inc.
Gaithersburg, MD 20877

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