Raw Material CTL Lead

Job Description

Duties and Responsibilities of the Raw Material CTL Lead include:

• Represent Client as the Single Point of Contact for all raw material test labs.
• Facilitate and effectively communicate information between Client and external test partners.
• Lead resolution of CTL (Contract Test Laboratories) operational issues that impact Client and collaborate with other Client functions to resolve other quality or technical issues.
• Track and communicate raw material sample testing status and delays to internal stakeholders and leadership teams.
• Obtain CoA release dates from contract test labs and weekly reports, and update internal trackers.
• Triage SCARs (and deviations and CAPAs as needed) related to raw material test labs and notify stakeholders.
• Create and distribute monthly raw material testing forecast to CTLs.
• Track accuracy of raw material test forecast and work with data analytics to resolve discrepancies.
• Update forecast data sheet monthly with updated and new raw material specifications.
• Approves CTL invoices and manages PO spend for each test lab.
• Be the first point of contact for CTL invoice resolution and ensure resolution of CTL invoice inquiries.
• Lead intake for new Products of work for raw material test labs: Gather requirements from end users, request quotes from CTLs, initiate sourcing request for SOWs, and create and own GMP POs.
• Gather operational metrics and content for business review meeting with CTLs.
• Support ES&P QMR with raw material test lab metrics (as requested).

Education Level:

• Master’s Degree, contract testing experience and 3+ years of experience in GMP or similar OR
• Bachelor’s Degree, contract testing experience and 5+ years of experience in GMP or similar OR
• Associate’s Degree, contract testing experience and 7+ years of experience in GMP or similar.
• High School Degree, contract testing experience and 10+ years of experience in GMP or similar.

Experience:

• Demonstrates knowledge of Good Manufacturing Practices (GMPs).
• Demonstrates experience working with contract test laboratories or other external contract organizations.
• Demonstrates working knowledge of collaboration within a matrix environment.
• Demonstrates diplomacy skills and ability to proactively identify and mitigate risks.
• Demonstrates outstanding organizational skills with the ability to multi-task and prioritize.
• Demonstrates strong analytical and problem-solving skills and strong data analytics skills e.g. Tableau, Excel.
• Demonstrates excellent oral and written communication skills.
• Demonstrates discipline in planning and plan execution.
• Quick learner of new technology/process/work environment and ability to translate learning to work plans for improving business performance.
• Patient centric mindset.
• Superior work ethic and a strong personal desire for success.