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Dir, Pharmacovigilance Quality Assurance

3 months ago

Gaithersburg, Maryland, United States Emergent BioSolutions Full time

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.

I. JOB SUMMARY

The Director, Pharmacovigilance Quality Assurance is a senior role responsible for overseeing and ensuring the compliance with Good Pharmacovigilance Practices (GVP) regulations, industry standards and internally established standards and practices for all investigational and marketed products. 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 Patient Safety and Epidemiology function. The incumbent will play a critical role in safeguarding the integrity and quality of Emergent's pharmacovigilance processes and systems and will embody a mindset of quality and compliance excellence. The position lies within the Quality department and will report directly to the Vice President of R&D Quality.



II. ESSENTIAL FUNCTIONS

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

Provides expert, current Good Pharmacovigilance Practices (GVP) quality management consultation to internal stakeholders
Develops, implements and maintains an inspection readiness program
Acts as the lead Quality representative for pre, during and post inspection activities including direct interactions with inspectors
Independently oversees and conducts GVP audits considering relevant regulations and industry standards
Conducts risk assessments as appropriate or procedurally required
Proactively escalates quality risks/ issues and recommends appropriate solutions to management for immediate and long-term resolution
Compiles and delivers quality management system performance metrics and insights to senior management
Leads investigations into PV Quality events, influences appropriate corrective and/or preventative actions and assures follow up and effectiveness of actions
Works cross functionally to establish and/or improve PV internal standards, processes and systems
Performs quality assurance review for PV and Quality related documentation including process modifications, aggregate reports and more
Prepares and maintains internally and externally-facing quality agreements in collaboration with stakeholders
Embraces the company's core values and demonstrates adoption through daily work and interactions with others.

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
A university degree (master's degree preferred) in a medical or science-related discipline
10 years or more of relevant work experience in PV Quality management with at least 5 years of EU GVP implementation experience.
Minimum of 3-5 years of direct experience in GVP auditing
Expert working knowledge and understanding of global regulations for safety and pharmacovigilance 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

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.