Specialist II, Data Gov & Risk Mgmt

Location
Gaithersburg, MD, US
Posted
Sep 06, 2020
Ref
649105500
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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.

JOB SUMMARY

The Quality Assurance Specialist II, Data Governance (DG) and Risk Management is responsible for ensuring compliance with EBSI's global Data Governance and Data Integrity (DI) Standards, in alignment with applicable GxP guidance and regulations, including GAMP5, 21 CFR Part 11 (US) and EU Annex 11. These activities include the ongoing development and deployment of the Data Governance deployment plan, Data Governance guidance and the Data Governance Standard. This position is located in Gaithersburg, MD.

ESSENTIAL FUNCTIONS

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

  • PDG/DI guidance to the sites, will coordinate and harmonize all site activities related to the DG rollout plan, and assess and measure DG mitigation activities related to the plan.
  • Responsible for the development of a Risk Management process for Global QA, working closely with the EBSI Enterprise Risk Management Team. This includes development and maintenance of applicable standards, procedures, risk register(s) and metrics.
  • Manage the Global Quality Data Governance Plan, in alignment with corporate goal (2.2.3) to achieve data integrity practices across the organization
  • Facilitate the Global/Site Data Governance work stream team
  • Create and manage metrics for site accomplishments and status, relative to requirements established in the global data governance plan
  • Monitor, manage and revise as needed, the Global Quality Data Governance Standard, Data Integrity Guidance, and Data Governance Plan
  • Participate on site Data Governance team meetings, as needed
  • Develop and deliver Data Integrity education and awareness materials, to enhance site level awareness of Data Integrity requirements, and associate accountabilities
  • Identify, assess and mitigate business change impact by owning the development and execution of user acceptance testing, training documentation, training scheduling and effective business communication
  • Responsible for the development and implementation of the Global Quality Risk Management process, including the management of the corporate QA risk register
  • Manage the harmonization of site level quality risk registers, identify common risk themes, and deliver a periodic report of risks across the Quality unit
  • Harmonize and align with the global Enterprise Risk Management process
  • Monitor emerging digital technology capabilities and related global regulatory requirements, and participate/contribute with EBSI workstreams as needed.

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
  • Education : Bachelor's Degree in biological or computer science, or equivalent experience in a Pharma/Biologics environment
  • Experience : Minimum of 5 years of pharmaceutical experience with specific experience applying 21 CFR Part 11 and EU Annex 11 requirements, along with broad working knowledge of other GxP and ISO regulations and guidance, specifically related to Data Integrity
  • Knowledge : Demonstrated experience in GxP best practices in a pharmaceutic/biologics environment, Global Data Integrity requirements, and/or computer systems compliance
  • Skills :
    • Ability to prepare effective reports and present to Senior Management
    • Ability to critically evaluate data summaries and conclusions
    • Proficient in all MS Office applications (Excel, PowerPoint, etc.)
    • This position requires close cross-functional teamwork, an ability to understand and communicate risk, and a desire to make a difference in the organization.
    • Knowledge and practical experience with quality metrics and trending
  • Abilities :
    • An established record of successful project completions, employing proven project management skills
    • Practical experience with quality risk management and risk-based validation approaches


PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
  • 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.


Travel:

Approximately 5% to 10% travel to other sites. May include international travel.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.