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Lead Quality / GxP Auditor

Pharmatek Consulting

Durham, North Carolina

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JOB DETAILS
SKILLS
Analysis Skills, Auditing, Benchmarking, Biotech and Pharmaceutical, Budget Management, Business Plan, Business Processes, Communication Skills, Conflict Resolution, Consulting, Cross-Functional, Customer Relations, GxP, Instructional Design, Medical Equipment, Metrics, Outsourcing, Project Design, Project Tracking, Project/Program Management, Quality Metrics, Realtime Transport Protocol, Replication and Remote Mirroring, Standard Operating Procedures (SOP), Startup, Strategic Planning, Team Lead/Manager, Team Player, Technical Writing, Time Management, Training Program Development, Training/Teaching, Usability Testing, Vendor/Supplier Management, Vendor/Supplier Relations
LOCATION
Durham, North Carolina
POSTED
4 days ago
Lead Quality/GxP Auditor Responsibilities:<\/span><\/span><\/b><\/span>
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Location: Durham NC<\/span><\/span><\/b><\/span>
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Duration: 12 months contract<\/span><\/span><\/b><\/span>
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  • Identify, analyze, and determine solutions regarding capability gaps<\/span><\/span><\/span>
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  • Partner with the business to define what a qualified RTP team member looks like based on their job responsibilities – then design an appropriate curriculum<\/span><\/span><\/span>
    <\/span><\/span><\/li>
  • Create, revise, and implement training and related documents, ensuring they are well written, executable, and compliant with applicable policies/procedures<\/span><\/span><\/span>
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  • Facilitate the review of documents and training materials to ensure compliance and learning requirements are met.<\/span><\/span><\/span>
    <\/span><\/span><\/li>
  • Ensure that training solutions are aligned to global strategy where appropriate by proactively connecting with the Global L&D organization<\/span><\/span><\/span>
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  • Ensure that current training courses/interventions are effective – and if not, identify an alternative and implement<\/span><\/span><\/span>
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  • Proactively identify areas where capability challenges exist and design interventions on how to reduce those issues.<\/span><\/span><\/span>
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  • Define ongoing ownership and maintenance plan for L&D interventions<\/span><\/span><\/span>
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  • Monitor learning budget for projects within assigned business area/function as applicable<\/span><\/span><\/span>
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  • Create initial project scope documents, appropriately leveraging learning services suppliers for outsourced work to achieve business objectives<\/span><\/span><\/span>
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  • Create, review and oversee execution of implementation plan(s), ensuring effective coordination with personnel who create and revise business area/function SOPs and other documents<\/span><\/span><\/span>
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  • Monitor and communicate program/portfolio status to key business partners<\/span><\/span><\/span>
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  • Anticipate and resolve project/program issues, escalating as appropriate<\/span><\/span><\/span>
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  • Oversee portfolio of projects to ensure on -time, on -budget creation of deliverables that meet quality standards, follow instructional design principles, are approved by appropriate personnel, and meet needs of business (including translations and any “Corporate Initiative” requirements).<\/span><\/span><\/span>
    <\/span><\/span><\/li>
  • Drive quality standards through review of project documents, design, deliverables, final learning content and evaluation data<\/span><\/span><\/span>
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  • Think strategically about the best way to train our team members – not just what has been done, but the best way to get them effectively trained and able to use their knowledge quickly.<\/span><\/span><\/span>
    <\/span><\/span><\/li>
  • Benchmark cross functionally within Lilly as appropriate, seeking sharing and replication opportunities<\/span><\/span><\/span>
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  • Establish strong relationship with suppliers and Lilly supplier management contacts to align on portfolio of projects and services and ensure seamless quality of deliverables.<\/span><\/span><\/span>
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  • Conduct usability testing as required<\/span><\/span><\/span>
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  • Share business metrics, interpretations, and solutions with Supervisor, business partners/process team<\/span><\/span><\/span>
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  • Participate regularly in area/function project and process teams.<\/span><\/span><\/span>
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  • Understand RTP functions deeply, including business goals, job titles and descriptions, key duties, and responsibilities<\/span><\/span><\/span>
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  • Monitor RTP team members’ satisfaction of learning programs and use that feedback to improve our programs<\/span><\/span><\/span>
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  • Consult across the assigned business area/function and the Lilly learning community to ensure training plans align with business plan, strategic direction, and compliance and ethics.<\/span><\/span><\/span>
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  • Influence your RTP team leaders to think about the most efficient and effective way to deliver training interventions that are meaningful, useful, and relevant to their roles<\/span><\/span><\/span>
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  • Manage suppliers working on L&D related projects to ensure delivery and performance mirrors or exceeds our agreements; ensure that the deliverables meet the needs of our site team members<\/span><\/span><\/span>
    <\/span><\/span><\/li><\/ul>

    <\/div><\/span>

    Requirements<\/h3>
    • Minimum 3 years of GxP auditing experience in related industry<\/span><\/span><\/span>
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    • Minimum of 5 years of experience within the Pharmaceutical / Biotech / Medical Device industry<\/span><\/span><\/span>
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    • Experience working in a GxP (regulated) environment.<\/span><\/span><\/span>
      <\/span><\/span><\/li>
    • Experience in technical writing<\/span><\/span><\/span>
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    • Demonstrated program/project management skills<\/span><\/span><\/span>
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    • Experience with learning & development business processes<\/span><\/span><\/span>
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    • This position needs to develop a GXP training program from the ground up<\/span><\/span><\/span>
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      • Demonstrated ability to establish strong business relationships<\/span><\/span><\/span>
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      • Demonstrated ability in communication, conflict resolution, and judgment and managing complexity<\/span><\/span><\/span>
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      • Working knowledge of business area/function<\/span><\/span>​<\/span><\/span><\/b><\/span>
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      • Experienced in Vendor management<\/span><\/span><\/span>
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      • Ability and willingness to challenge business partners regarding ways to use learning interventions to most effectively meet business requirements<\/span><\/span><\/span>
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      • Ability to work independently and in a team environment.<\/span><\/span><\/span>
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      • Strong start -up mindset – think deliver execute review cycle.<\/span><\/span><\/span>
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      • Strategic operator – think of where we need to go, but also the tactical ways to get there<\/span><\/span><\/span>
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      • B.S./B.A. in scientific discipline as a minimum<\/span><\/span><\/span><\/span>
        <\/span><\/span><\/li><\/ul><\/div>

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About the Company

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Pharmatek Consulting