1+ months

Compliance Systems & Process Specialist

King of Prussia, PA 19406
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Jun 2 2020

The Compliance Systems and Process Specialist position is responsible for driving compliance across BPDS quality systems and processes via application of Veeva Quality Docs (VQD) information management software. The incumbent will concurrently ensure robust integration of Veeva Quality Docs (VQD) functionalities that leverage performance efficiencies and new electronic ways-of-working across BPDS groups. This role directly supports right-first-time manufacture and testing of onsite BPDS pilot plant assets and third-party partners involved in the manufacture of external assets.

Role responsibilities include VQD task-based issuance and reconciliation responsibilities for critical GxP activities (generating, editing, issuing, reconciling, archiving of manufacturing batch proforma, logbooks, specifications, methods, protocols, reports, analytical methods, media/buffer forms). Activities are performed and aligned to Global Quality Policies and supporting standard operating procedures. The incumbent will also drive identified compliance system enhancements that ensure core activities are fulfilled and aligned to organizational role-based training. Deliverables in scope are time-sensitive and require the incumbent to be flexible in adapting to asset manufacturing schedules and timelines.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

  • Controlled issuance and reconciliation accountabilities specific to applicable proforma via leveraging VQD (batch records, media forms, logbooks, protocols, etc.) required for execution within onsite manufacturing areas.
  • VQD document attribute and content quality editing on Controlled Documents (SOPs, Instructions, Material Specifications, Analytical Methods, Validation Protocols, etc.) that align with regulatory expectation, GSK SOPs and cGMPs prior to sending for review and approval.
  • VQD author training and support in creating documents and workflows with front-facing direct support on the use of Microsoft Word advanced functionalities (styles, cross-references, tables, picture, embedded objects, etc.). Examples include assurance that documents render properly in VQD and that appropriate reviewers and approvers are assigned to workflows.
  • Obtain, track and organize project-specific data from various data repositories/ SharePoint systems in support of external partnerships.
  • Interface with various departments inside/outside of BPDS as required to obtain reports, protocols, methods, memos, notebooks, batch records and other forms of GMP documentation that will support BLA filings.
  • Coordinate the issuance and reconciliation of batch records and logbooks via VQD using both manual and electronic document management systems as assigned.
  • Other related documentation tasks and training as assigned.
  • Application of knowledge and leveraging of continuous improvement activities utilizing available tools where applicable that support continued adherence with industry regulations, Global Quality Policies (GQP 3201A and GQP 3201B) and supporting business procedures.
  • Leads the preparation and delivery of targeted VQD training materials and user guides aligned to promote broader adoption and increased knowledge of BPDS compliance systems. Designs and conducts VQD user training sessions, with emphasis on increasing user awareness and engagement on tools and templates that simplify manufacturing and aligned compliance processes.
  • Proactively communicates the status of critical compliance systems support and problem resolution. Ensures effective problem analysis and resolution of issues of diverse scope in a timely fashion and escalates issues when needed to appropriate levels of QRMC management.
  • Applies metric generation and reporting for QRMC-led quality processes aligned to VQD activities (periodic review, controlled issuance, reconciliation, etc.).
  • Ensures lifecycle management that includes archiving QRMC-DC controlled issued documentation to Records Management and Administration (RMA) within the VQD system.
  • Works collaboratively via continually embracing GSK Values and Expectations while effectively implementing solutions. Develops and maintains mutually productive relationships in the workplace. Builds and leverages their own networks of expertise formed with other senior internal and external personnel for the benefit of the team.
  • Leads the identification and implementation of strategies to improve the qualities and efficiencies of QRMC processes, systems and results. Maintains strong compliance systems understanding of current technologies and professional concepts.
  • Responsible for scheduling and planning work to meet priorities set by supervision. Sets specific daily and weekly priorities to meet timelines. Recommends procedures and policies to supervision.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • BA/BS in scientific or health care discipline typically with minimum of 3 years relevant experience
  • Experience with controlled document computer systems required
  • Experience with Core Quality Systems in a GMP environment (for example, Deviation Handling, CAPA Management, Change Management, Documentation authoring/approval, or Validation Lifecycle Documentation) required

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Strong interpersonal skills required
  • Strong verbal and written communication skills required
  • Management of lifecycle document management system as an administrator
  • 3 years compliance systems experience
  • Keeps current on governmental regulatory requirements and GSK standards related to biopharmaceutical clinical manufacture and control
  • Experience with learning management systems
  • Experience with analysis and visualization tools (e.g. Spotfire, Linguamatics, Power BI)
  • Biotechnology experienced
  • Ability to communicate, influence and negotiate at various levels
  • Broad knowledge of the R&D Drug Development Process

Why GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Agile and distributed decision-making using evidence and applying judgement to balance pace, rigour and risk
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.

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Posted: 2020-06-03 Expires: 2020-08-02

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Compliance Systems & Process Specialist

King of Prussia, PA 19406

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