Quality Manufacturing Documentation / Data Lead
- BA/BS in scientific or health care discipline with a minimum of 5 years' relevant experience in controlled document management systems
- 3 years Document Compliance experience.
- Strong interpersonal skills.
- Strong verbal and written communication skills.
- Ability to keep current on governmental regulatory requirements and GSK standards related to biopharmaceutical clinical manufacture and control.
- Experience with learning management systems.
- Biotechnology experience.
This position is required to drive adherence of documentation requirements that meet the B38 manufacturing schedule as well a process simplification of compliance processes aligned to GQP 3201A and GQP 3201B (QMS Documentation and Data). Role responsibilities include end-to-end oversight of critical GxP documentation activities (generating, editing, issuing, reconciling, archiving of manufacturing batch documentation, proformas, logbooks, specifications, methods, protocols, reports, analytical methods, sample request forms, media buffer forms and mini manuals for all manufacturing and testing areas. Documentation deliverables in scope are time-sensitive requiring the incumbent to be flexible to adapt to the asset manufacturing schedules and timelines.
This position leads document and data control activities in support of Biopharm Product Development and Sciences (BPDS) activities with minimal guidance from management. The selected candidate performs day-to-day, highly regulated Quality and Compliance activities that support authorization and effective approval. These activities include:
- Generating, editing, issuing and reconciling manufacturing batch documentation, proformas, logbooks, specifications, methods, protocols, reports, analytical methods, sample request forms, media buffer forms and mini manuals in support of Building 38 and all associated manufacturing and testing areas.
- Application of knowledge and leveraging of continuous improvement activities specific to documentation and data management. Actions and deliverables must comply with industry regulations, Global Quality Policies (GQP 3201A and GQP 3201B) and supporting business procedures.
- Leads administration of the electronic Controlled Document Management System (CDMS) and migration, training, and overall BPDS adoption activities aligned to LSQM (Lifesciences Quality Manufacturing Module) implementation.
- Oversight of workflow/content editing activities that ensure submission-ready documents aligned to both global regulatory and GSK expectations.
- Support of related activities aligned to myLearning (GSK Learning Management System). Supports the management of items and curricula updates in learning management system for all BPDS role-based training administration activities.
- Metric generation and reporting for QRMC-led quality processes (periodic review, controlled issuance, reconciliation, etc.). Leads the effective document process, which includes notifications and analytical method provision to third party partners and BPDS document notifications.
- Lifecycle management that includes archiving QRMC-DC controlled issued documentation to Records Management and Administration (RMA) via the PIER system.
- Assisting authors with the use of Microsoft Word advanced functionality (styles, cross-references, tables, pictures, embedded objects, etc).
- Performs classroom training for new users providing document compliance author, reviewer and approver instruction to all BPDS authors
- Delivers urgent and critical requests from stakeholders in a timely manner
- Supports actions as an inspection lead for external audits, internal assessments, regulatory filings and related activities.
- Interfaces with various departments inside/ outside of Biopharm to obtain reports, protocols, methods, memos, notebooks, batch records and other forms of GMP documentation that will support BLA filings.
- Proactively interprets regulations as they apply to function. Within established guidelines, determines appropriate course of action to assure compliance. Keeps current on governmental regulatory requirements and GSK standards related to biopharmaceutical clinical manufacture and control.
This position includes performance and coordination of certain activities that assure GxP compliance of manufacturing and control operations and alignment to Global Quality Polices on data and documentation (GQP 3201A and GQP 3201B). This includes performance and coordination of GxP documentation and data activities that ensure regulatory compliance of manufacturing and control operations. This individual will be accountable for scheduling and planning work to meet priorities set by supervision, setting specific daily and weekly priorities to meet timelines and recommending procedures and policies to supervision.
You may apply for this position online by selecting the Apply now button.
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