Quality Documentation Expert

Basic qualifications:

  • At least 5 years of practical experience in Pharmaceutical or Biopharmaceutical Industry, preferably in Manufacturing, Quality (QA/QC), or Development.
  • Experience with Quality Systems management. Specific experience with document management would be an advantage.
  • Expertise in biological/vaccine manufacturing processes, deviation writing and investigations, resolution of issues or identification of mitigation strategies, generation of new ideas to resolve issues
  • Writing of SOPs, documentation within Quality systems,
  • Good report writing skills with a good command of English
  • Ability to lead in a matrix organization and to influence a sizable network of scientists and management
  • Ability to simplify and abstract complex relationships
  • Strong communication skills with the capability to influence and manage people including communication to senior management
  • Energetic and passionate for driving change and improvements. Innovative thinking to drive changes and respond to organizational and/or operational challenges

Ability to manage relationships at all levels and across internal/external and functional boundaries.

Preferred qualifications:

  • Master’s Degree in a scientific discipline is preferred
  • Track record in working in international project teams in international setups with de-centralized structure and on remote locations
  • Ability to speak French, German or Italian a plus.

Experience working with SAP

Details:

We are seeking a Quality Documentation Expert to support the Quality Integration Team at our new U.S. R&D Center in Rockville, Maryland. You will have the opportunity to be on the ground floor of a new organization and a new facility, and you will be part of building a new culture of some of the best scientific minds in vaccine research. Come deliver the GSK Vaccines strategy by driving vaccine R&D through innovation, collaboration, cutting edge science, exceptional people, and end-to-end quality performance.

In this role, you will support the Quality Integration program to unify and integrate processes across the Vaccines business in the following ways:

Serving as key player in the documentation for Biological Process Deviation Reports (BPDRs), and supporting the integration activities for BPDR and other processes, as required

Working to create a New Vaccines SOPs (VSOPs) including scope, content type and level of detail (vs GQP/GQMP)

Playing a key role in the Documentation Business Process integration, including the tracking and maintenance of the BPDR status for all GSK manufacturing sites

Communicating to all respective functions and participate in the determination of deviations, draft writing of BPDRs

Ensuring timely reviews and filing of BPDRs to the FDA within duly established timeframes

Participating in implementing the new Corporate QMS procedures as required, developing, formalizing and training of the new BPDR processes

Engaging stakeholders across all GSK Vaccines Sites and within the Global SME community to secure their support for the initiatives

Contact information:

You may apply for this position online by selecting the Apply now button.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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