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Sr. Dir, Compliance Investigations

Employer
Emergent BioSolutions
Location
Gaithersburg, MD
Start date
Mar 22, 2023

View more

Discipline
Regulatory, Legal/Compliance
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
BioCapital

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.

I.    JOB SUMMARY 
Emergent is focused on continuing to evolve its strong quality, ethics, risk, and compliance culture. Our Ethics and Compliance team is seeking collaborators, innovators, architects, and problem solvers. Our team values drive us and are non-negotiable: we respect each other, have a “we” over “me” mentality, embrace diversity and inclusion, communicate transparently, and are committed to joy in our work. 

Emergent seeks an experienced legal professional to take a leadership role in continuous development of Emergent’s Investigations program.  The Senior Director, Compliance Investigations will report directly to the Chief Ethics and Compliance Officer, and will be responsible for developing, implementing, and the day-to-day operation of Emergent’s Investigations program.  This role is integral to the organization and serves as a key member of the Ethics & Compliance team.

 

II.    ESSENTIAL FUNCTIONS
•    Responsible for the development and administration of Emergent’s Investigations program.  Continue to build an effective Investigations program, in coordination with HR and Legal partners.
•    Develop and evolve Emergent’s investigations framework, reporting structure,  process, and procedures.
•    Develop and train cross functional colleagues who conduct investigations on the process and appropriate management of an internal investigation  
•    Drive the evolution of investigations reporting to executive leadership and the Board of Directors: develop dashboards to display reporting and investigations metrics, analyze trends, benchmark progress, and distill insights.
•    Conduct investigations of varied complexity and scope: gather and analyze data, interview colleagues, write reports, make practical recommendations for remediation, and document all steps.  
•    Partner with Quality and HR to evolve Emergent’s culture of Quality and Compliance, particularly Emergent’s “Speak Up” program.
•    Establish operating policies and procedures related to investigation processes and protocols.
•    Work with the Chief Ethics and Compliance Officer and Compliance Business Partners to interpret organizational policies and to implement remediation following an investigation, which may include modifying policies, enhanced training, coaching, or monitoring.   
•    Assist in creation of tools and templates for investigations as well as improvements to tools used for reporting.
•    Assist with other assurance-related compliance activities as appropriate, including monitoring and auditing.
•    Ensure compliance to the Code of Conduct as well as promote a culture of compliance and ethics within the company.
•    Support the legal team with litigation as necessary.

 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

•    Juris Doctor Degree.
•    10+ years of experience in compliance or legal field, ideally advising pharmaceutical, biotechnology, or life sciences companies.
•    Experience investigating matters concerning pharmaceutical industry and manufacturing-related regulations.
•    Strong interpersonal skills, including the ability to advise, counsel, and interact effectively with a variety of stakeholders.
•    Strong presentation, influencing, negotiation and mediation skills.
•    Ability to communicate with all levels of management and employees, both in writing and verbally.
•    Possess sound, practical judgment in the interpretation and application of relevant laws, regulations, industry standards, and company policies..  
•    Self-motivated, proactive,and able to work with minimal supervision.
•    Able to exercise sound judgment in resolving complex matters and escalating matters appropriately.
•    Strong analytical and critical thinking as well as demonstrated accuracy and attention to detail.
•    Ability to work with large amounts of data to analyze information while still seeing the "big picture".
•    Ability to handle multiple tasks in a fast-paced environment is essential.
•    Excellent project management skills with the ability to organize and manage multiple priorities while meeting deadlines.
•    Able to handle confidential information appropriately and the discretion to work on sensitive internal investigations.
•    Confidence and professionalism to handle difficult conversations and discretion on sensitive matters.
•    Maintain a high degree of interest in professional development; attend relevant compliance and investigations training sessions and conferences and maintain ongoing professional credentials.
•    Demonstrated strong commitment to compliance, ethics and accountability.
•    Ability to travel approximately 20% of time.    

 

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.

Company

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

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Find Us
Website
Phone
240-631-3200
Location
400 Professional Drive
Suite 400
Gaithersburg
Maryland
20879
US

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