drjobs Lead Quality GxP Auditor العربية

Lead Quality GxP Auditor

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1 Vacancy
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Jobs by Experience drjobs

5years

Job Location drjobs

Durham County - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Lead Quality/GxP Auditor Responsibilities:
Location: Durham NC
Duration: 12 months contract
  • Identify analyze and determine solutions regarding capability gaps
  • Partner with the business to define what a qualified RTP team member looks like based on their job responsibilities then design an appropriate curriculum
  • Create revise and implement training and related documents ensuring they are well written executable and compliant with applicable policies/procedures
  • Facilitate the review of documents and training materials to ensure compliance and learning requirements are met.
  • Ensure that training solutions are aligned to global strategy where appropriate by proactively connecting with the Global L&D organization
  • Ensure that current training courses/interventions are effective and if not identify an alternative and implement
  • Proactively identify areas where capability challenges exist and design interventions on how to reduce those issues.
  • Define ongoing ownership and maintenance plan for L&D interventions
  • Monitor learning budget for projects within assigned business area/function as applicable
  • Create initial project scope documents appropriately leveraging learning services suppliers for outsourced work to achieve business objectives
  • 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
  • Monitor and communicate program/portfolio status to key business partners
  • Anticipate and resolve project/program issues escalating as appropriate
  • Oversee portfolio of projects to ensure ontime onbudget 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).
  • Drive quality standards through review of project documents design deliverables final learning content and evaluation data
  • 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.
  • Benchmark cross functionally within Lilly as appropriate seeking sharing and replication opportunities
  • Establish strong relationship with suppliers and Lilly supplier management contacts to align on portfolio of projects and services and ensure seamless quality of deliverables.
  • Conduct usability testing as required
  • Share business metrics interpretations and solutions with Supervisor business partners/process team
  • Participate regularly in area/function project and process teams.
  • Understand RTP functions deeply including business goals job titles and descriptions key duties and responsibilities
  • Monitor RTP team members satisfaction of learning programs and use that feedback to improve our programs
  • 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.
  • 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
  • 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


Requirements

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


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

Employment Type

Full Time

Company Industry

Pharma / Biotech / Clinical Research

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