Sr Director Global Compliance Programs and Operational Effectiveness

Location: 

Gaithersburg, MD, US, 20879


 

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.

I.    JOB SUMMARY 
Emergent is focused on continuing to evolve its strong ethics and compliance culture. The Compliance team is seeking collaborators, innovators 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 and are committed to joy in our work. The Sr Director Global Compliance and Operational Effectiveness is a leader on our team and is a key driver of our culture. They are responsible for the execution of strategy and programs related to the critical activities, initiatives, and day-to-day operations of the Global Compliance function.

This role will also support the CECO in internal and external meetings, including planning with other functions and business partners to ensure alignment across the organization and lead the creation of appropriate materials, including the development of policies, presentations and coordinating events.

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

Head of Global Compliance Programs
•    Overseas Policy Office including strategy, implementation and coordination of policy development
•    Drive overall training and communication of Global Compliance function and other key culture initiatives
•    Build internal knowledge management process and capabilities

Operational Effectiveness
•    Enable operational excellence by partnering with team members to support the maturation of the company's Compliance Program. Drive alignment and coordination of efforts across Global Compliance
•    Support a culture of excellence by instilling a culture of accountability, setting clear expectations and measuring results.
•    Acts as the conductor for harmonious flow of work. Plans and supports administrative, financial, and operational activities for the function.
•    Develops partnerships with key colleagues in other functional areas to ensure ongoing alignment of goals and strategies, as well as increased efficiency
•    Supports the CCO by partnering with HR to ensure effective organizational planning, organizational changes, and talent development
•    Manages and tracks commitments made by the CCO and executes follow-up activities as appropriate.
•    Provide strategic thought partnership to the CCO.
•    Provides insight into overall Global Compliance budget, proactively anticipates issues that may have impact on the overall budget. Participates in developing and/or coordinating financial planning activities with Finance
•    Work with the leadership team to shape, communicate and embed the key strategic priorities for function, including development of annual objectives and longer-term priorities
•    Manage process for setting priorities and objectives as well as tracking progress and related updates.  Identify opportunities to increase efficiencies and improve performance.
•    Maintain a working knowledge of the various laws, regulations, and industry guidance relevant to the compliant commercialization of pharmaceutical products. This includes but is not limited to the Federal Anti-kickback Statute, False Claims Act, Food Drug and Cosmetics Act, the OIG and DOJ guidelines, PhRMA Code, US state and local marketing compliance laws and recent government enforcement actions. Knowledge on government contracting requirements as set forth in the FAR, DFARS, and HHS regulations a plus.
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

Education: BA/BS degree required. Master’s Degree or J.D. is strongly desired.

Experience: 10-15 years relevant compliance experience in pharma, biotech or related environment, preferably with a globally operating company.

Knowledge: Demonstrated knowledge of relevant laws governing the business activities of international pharmaceutical companies (anti-kick; data privacy; HCP spend transparency; price reporting), regulations and industry guidelines.

Demonstrated skill with digital and tech-enhanced communications and learning platforms. Comfortable developing metrics to enable the continued evolution of the compliance program.

Demonstrated sound judgment and acts with integrity and ethics in all dealings, possesses humility, self-awareness, sense of humor, and openness to various perspectives.
•    Has strong organizational awareness, business acumen and ability to:    
•    lead and influence without direct authority 
•    enlist the support of various business functions as needed to achieve objectives
•    collaborate, encourage cooperation and teamwork across functions 
•    interact effectively at all levels to influence culture and business practices
•    be creative and flexible in order to effectively communicate 
•    balance a strong commitment to customer service and corporate ethics
•    effectively prioritizes and work in a fast-paced environment 
•    handle multiple complex and confidential tasks    

 

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.

ABOUT EMERGENT

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 actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • 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.


Nearest Major Market: Washington DC