Director, Quality- Post Marketing Surveillance
- Emergent BioSolutions
- Gaithersburg, MD
- Start date
- Mar 9, 2023
- Clinical, Drug Safety/Pharmacovigilance, Information Technology, Business/Data Analytics, Marketing, Product Development/Management, Health Economics & Outcomes Research
- Required Education
- Masters Degree/MBA
- Position Type
- 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.
The Director of Post Marketing Surveillance will oversee the deployment of Emergent BioSolutions Inc. (EBSI) Post Marketing Surveillance framework across the GxP lifecycle. The position will manage and maintain the Complaints processes, as well as tracking and trending all post marketing surveillance activities across the 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 Post Marketing Surveillance (PMS) planning activities, to drive regulatory compliance and quality across GxPs.
- Ensure PMS framework processes are established, implemented, audited, and continuously improved.
- Oversee the Complaints program ensuring a fully compliant system for documenting relevant investigations, tracking, trending, and reporting.
- Collaborate with pharmacovigilance and medical in the implementation, maintenance and continuous improvement of a fully compliant post marketing surveillance program.
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
- 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 post marketing surveillance.
- 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.
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 www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.
Stock Symbol: EBS
400 Professional Drive
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