Sr. Director, Clinical Dev. Quality Assurance

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.

JOB SUMMARY

The Senior Director of Clinical Development Quality is responsible for ensuring that clinical development programs adhere to current Good Clinical Practice (GCP), applicable regulatory requirements, and internal standards. This position requires a strategic leader with strong systems-thinking, problem-solving and risk management skills and the ability to partner collaboratively, and provide expert consultation to, the Clinical Development function. This role drives inspection-readiness, proactive risk mitigation, and sustainable quality culture across clinical teams and vendor partners. The successful candidate will combine subject matter expertise with strategic vision to support the development of innovative therapeutics and will embody a mindset of quality and compliance excellence.

RESPONSIBILITIES

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

* Provides expert, current Good Clinical Practices (GCP) quality management consultation on protocol development, trial conduct, vendor oversight, and issue resolution
* Leads regulatory inspection readiness efforts including cross-functional preparation
* Acts as the lead Quality representative for pre, during and post inspection activities including direct interactions with inspectors* Establishes and manages proactive risk-based quality frameworks and metrics across all clinical programs
* Proactively escalates quality risks/ issues and recommends appropriate solutions for immediate and long-term resolution
* Partners with Clinical Development, Regulatory Affairs, Pharmacovigilance, and external CROs to drive operational excellence and compliance
* Leads investigations into quality events, influences appropriate corrective and/or preventative actions and assures follow up and effectiveness of actions
* Leads the design, implementation, and continuous improvement of GCP-compliant processes, including clinical trial oversight and documentation standards
* Proactively collaborates with stakeholders to ensure that internally and externally-facing quality agreements are executed and maintained where applicable
* Embraces the company's core values and demonstrates adoption through daily work and interactions with others.
* May assume responsibility for supervising, managing, and/or mentoring others ensuring alignment with organizational objectives, fostering professional growth and cultivating a high-performance team.

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.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

* A university degree (master's degree preferred) in a medical or science-related discipline
* 10 years or more of relevant work experience in Clinical Development Quality management with at least 5 years in a leadership role
* Expert working knowledge and understanding of global GCP regulations including US, EU and ICH guidelines.* Demonstrates leadership presence, strong decision-making capabilities and personal accountability; particularly in a cross-functional team/ project setting
* Ability to build and influence cross-functional stakeholder relationships
* Excellent critical thinking, problem-solving and negotiation skills
* Ability to manage multiple priorities and tasks in a dynamic environment
* Effectively navigates organizational dynamics
* Strong verbal and written communication skills with ability to present to various audience levels including senior level management

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from [$XXX to $XXX]. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

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.