Dir. Global Quality Enabling Tech eQMS

Location
Gaithersburg, MD, US
Posted
Oct 28, 2020
Ref
686960700
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.
  1. JOB SUMMARY

The Director, Global Quality Enabling Technologies Electronic Quality Management System (eQMS) will have overall responsibility of developing and maintaining the enterprise wide end to end eQMS solution leveraging the Veeva eQMS product suite. The incumbent will lead our enterprise wide eQMS technology implementation, delivering harmonized outcomes-based user requirements to drive technology design and functionality, aligned to Emergent's Quality Management Systems and compliance goals and objectives.

This role will serve as the eQMS "Veeva" business system owner/expert driving initial implementation, strategic integrations, and maintenance releases across the enterprise. The role holder will establish and lead cross-organizational governance and collaboration teams of function/site eQMS SMEs and representatives to carry out these activities,

This role reports to the Sr, Director Global Quality Enabling Technologies and will work closely with IT, Quality, business functions and sites. Change and stakeholder management across the business, and in collaboration with senior leaders is a critical requirement of this role. It is incumbent of this role to demonstrate Emergent's core values and leadership competencies.

  1. ESSENTIAL FUNCTIONS

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

  • Lead cross functional teams to ensure fit for purpose eQMS "Veeva" functionality is prioritized, deployed, and effective.
  • Lead cross-functional/strategic eQMS "Veeva" project activities (process & technological), and ensure proper project management, prioritization, and flawless execution in full quality and per agreed timelines.
  • Ensure continuous improvement and process innovation for eQMS processes and systems based on QMS metrics, and in close collaboration with colleagues within the Global Quality Systems and Compliance team and across the EBSI enterprise.
  • Contribute to and execute the business roadmap for the Veeva Platform working with Information Technology partners to ensure demand is prioritized, projects and solutions are effective and business functions are supported.
  • Design, improve and implement robust and controlled quality management systems process solutions utilizing Veeva eQMS to ensure effective integration with other business functions and applications
  • Oversee the development and implementation of Emergent's eQMS that ensure the appropriate controls, addresses regulatory requirements, data consistency and availability. Ensure related policies, guidelines and day to day execution is effective and efficient.
  • Continually improve the use of eQMS processes and tools.
  • Support the implementation of consistent and efficient eQMS integration approaches for merger and acquisition initiatives
  • Contribute to Emergent's eQMS strategic objectives and collaborate on updating the Quality Assurance IT roadmap based on those objectives and in overall alignment to the Quality Assurance IT Strategy.
  • Develop and continually improve an eQMS "Veeva" merger and acquisition integration playbook and template approach and lead the implementation of mergers and acquisitions for eQMS.
  • Collaborate with the Quality Systems Governance team, Business Process Owners, Sites and Functions to define and deploy best in class QMS process and integration improvements utilizing industry and "Veeva" best practices
  • Contribute to and execute the technology vision for the eQMS "Veeva" Platform and work with business partners to propose enhancements to support Emergent.
  • Lead eQMS "Veeva" technology initiatives, develop project plans and manage the implementation.
  • Ensure project deadlines and schedules are met; ensure project team members prioritize multiple tasks effectively and understand the components of running a fiscally successful project.
  • Coach/advise project team members on project management best practices and consistent application of project standards.
  • Partner with appropriate Emergent personnel to understand project concept, objectives, and approach.
  • Partner with the business owner and project management to define project scope and objectives


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

  • Bachelor's degree from accredited college or university is required specializing in computer science, information systems, or a related field; advanced degree strongly recommended.
  • People management experience (direct/matrix).
  • 5-8 years of significant experience in the pharmaceutical industry, preferably with track record in project management, quality, and compliance.
  • Strong knowledge of computer information systems including needs assess, cost/benefit analysis, and implementation track record on global organizational level
  • Extensive track record of successful project and process management specifically information systems projects.
  • Excellent leadership, interpersonal, communication, and problem-solving skills
  • Sound understanding of regulated activities, health authority expectations, and GxP.
  • Demonstrated leadership in implementing robust quality systems and setting global quality controls in a regulated area.
  • 5+ years of Veeva functional experience in the eQMS environment or any equivalent combination of education, experience and training that provides the required knowledge, skills, and abilities.
  • 5+ years of experience in eQMS "Veeva" application support and delivery in a validated pharmaceutical manufacturing environment leveraging SAP capabilities and best practices.
  • Knowledge in Computerized System Validation
  • Knowledge of Quality Assurance/Compliance, 21 CFR Part 11 and other FDA regulations
  • Proven project management and leadership skills, including the ability to gather clear business requirements and develop value-based business cases.


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.