Lead Quality

1 month ago

india Pharmatek Consulting Inc Full time
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 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).
  • 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 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
  • B.S./B.A. in scientific discipline as a minimum

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 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

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