Purpose

Purpose

The QC Validation Manager provides leadership and direction to the Quality Control organization pertaining to new product introduction of clinical and commercial projects. Expectations that the QC Validation Manager will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.

Responsibilities

• Communicates with Management for Quality Management Review, Quality Initiatives, etc.
• Attends, coordinates and presents at internal and external teleconferences pertaining to new product introductions
• Responsible for coordinating cross-functional activities to ensure validation timelines stay on target.
• Leads and influences peers and colleagues within the scope of their work
• Leads method validation activities for incoming projects (both internal and external), including but not limited to protocol creation and execution, validation data tabulation and review; validation summary report creation and review
• Support method transfer activities to other sites, including but not limited to tech transfer memo creation and execution, transfer data tabulation and review; method transfer summary memo creation and review
• Assist with regulatory filings and audits as required
• Write and revise SOP’s in support of the Quality Control organization
• Incumbent is responsible for quality decisions related to their functional area to ensure compliance with AbbVie Quality Systems and cGMPs