Andrew Strait
- Role
- Senior Manager - Process & Compliance, Fill Finish Value Stream at Genentech
- Location
- Portland, OR, US
- LinkedIn followers
- 500 followers
About Andrew Strait
Highly driven people-centric leader with 12+ years of managerial experience in the…
Experience
Senior Manager - Process & Compliance, Fill Finish Value Stream
Aug 2023 — Present
Accountable for end-to-end process and systems management in the areas of business performance, business analytics, Lean Production System (LPS) integration, Master Data management, GMP documentation, UPE/CAPA management & RCA, Regulatory Inspection Readiness, General Compliance, and both GMP and professional development training programs. Responsible for provision of lateral leadership of the VS on a tactical level, which involves management and oversight of day to day production activities with the goal of reducing variability with frontline execution, helping ensure optimal flow of information, escalations and communication, increasing the operating effectiveness of the organization via continuous improvement, and ultimately enabling the reliable OTIF delivery of commercial production commitments in a safe and compliant manner- Accountable for VS KPIs and Metrics management, data collection, and establishing/executing routine performance review within the VS- Accountable for driving RFT culture and strengthening overall compliance within the VS and end-to-end management, oversight and execution of Robust RCA/structured problem solving initiatives- Accountable for management and oversight of deviations and quality performance of the VS. As well as business processes surrounding Technical changes, Document updates, and Customer Complaints, acting as a key interface with Quality functions throughout each of these processes- Represents the Commercial Value Stream in regulatory inspections, as needed, and serves as SPOC for triage of all compliance related needs/requests- Establishes & actively engages with network peers/colleagues to facilitate knowledge exchange, share best practices, and collaborate strategically on business initiatives and exchange of talent possibilities- Actively manages VS capacity model(s) to ensure workforce is right-sized for all operations- Accountable for Project KPI management
Skills
- Sales
- Multitasker
- Marketing
- Microsoft Excel
- Team Leadership
- Organization
- Powerpoint
- Leadership
- Networking
- Microsoft Word
- Event Planning
- Inventory Management
- Customer Service
- Social Media
- Public Speaking
- Typing
- Microsoft Office
- Data Entry
- Gmp
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