Quality Documentation Expert
- 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.
- 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
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
You may apply for this position online by selecting the Apply now button.
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