Sr. DIrector, Global Quality Enabling Technologies

Location
Gaithersburg, MD, US
Posted
Nov 08, 2020
Ref
659980300
Discipline
Quality, Quality Control
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
JOB SUMMARY

The Sr. Director, Global Quality Enabling Technologies will oversee the evaluation of process performance and re-engineering of current quality systems to increase the effectiveness and efficiency of Emergent BioSolutions enterprise wide Quality Management System (One QMS). This position will design and deploy cost effective continuous improvement lean-agile strategies in partnership with EBSI's Business Units, sites, and Information Technology teams.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Lead cross functional teams consisting of representatives to ensure continuous improvement of the governing QMS processes and eQMS technology solutions through periodic enhancements and upgrades.
  • Lead cross-functional/strategic eQMS 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.
  • Consult with the VP, Global Quality Systems & Compliance on strategic eQMS topics and projects, identify areas of focus, define and plan activities, manage execution along agreed project timelines and deliverables, monitor progress, and take corrective action where necessary.
  • eQMS Enabling Technologies
  • Collaborate with colleagues within the Global Quality Systems and Compliance team and across the EBSI enterprise to ensure new and emerging process and data needs are identified and planned for respective eQMS Technology Roadmap.
  • Collaborate with EBSI's Business Units, sites, Information Technology teams and QS&C functional leads/teams to ensure robust eQMS technologies (e.g., LMS, DMS, LIMs, SQM). Establish, and maintain system ownership for applicable systems.
  • Liaise with internal EBSI IT and external system vendors on topics related to system performance, security access, upgrades and planning.
  • eQMS Continuous Improvement
  • Lead alignment of quality technology deliverables and linkage to annual global quality planning activities, defining specific technological activities/actions to drive quality performance and quality across GxPs
  • Ensure proper project management, prioritization and alignment of all quality technology project activities in the eQMS Technology Roadmap, fulfilling requirements of the global quality plan.
  • In collaboration with the Data & Analytics team, ensure pre-defined eQMS continuous improvement metrics are in place and assessed in collaboration with stakeholders across the EBSI enterprise.
  • Serve as PMO (e.g. work breakdown structure, communication plan, and risk log) lead of the eQMS Technology Roadmap and Annual Quality Planning deliverables. Ensure flawless planning and execution of all deliverables.

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
  • People management experience (direct/matrix).
  • 10-12 years of significant experience in the pharmaceutical industry, preferably with track record in the area of 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.
  • Experience on large scale business process re- engineering project(s) performing analysis, process design/reengineering, development, integration, and implementation of system improvements.
  • 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.
  • Relevant experience and track record in IQP/LEAN/Six-Sigma methodologies
  • Ability to influence and drive/facilitate change across the organization.
  • Demonstrated leadership in implementing robust quality systems and setting global quality controls in a regulated area.
  • Operational Excellence/Lean Six Sigma experience a plus


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.

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.

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