Head of Centralized Services for Investigations, Site Scheduling & Continuous Improvement

Job Description

About This Role

Reporting to the General Manager, the Head of Centralized Services for Investigations, Site Scheduling & Continuous Improvement is part of the Site Leadership team. You will drive key site operations initiatives for Lean implementation, Risk Portfolio Management, Manufacturing Resource Planning, Quality Investigations, Financial Project Tracking and other GMTO and PO&T priorities as driven by strategic goals. In partnership with the Site LT and other global functions, you will develop the year-over-year strategic plan & goals and identify key programs, capital projects and initiatives to ensure the continuous improvement of Quality, Safety and Operational Efficiency.

• Investigations - The Investigations Team is accountable for maximizing organizational learning and improvement from high-risk Quality deviations. You will ensure analytical cause analysis techniques are applied to each investigation within the RTP BIO Site across all three factories. You'll maintain key partnerships with stakeholders from all areas of the business to ensure actions taken as a result of events prevent or mitigate the risk of future recurrence.  Effective communications to stakeholders and management of activities will be key to ensure completion per regulatory and product release timelines. You'll provide guidance on the organization’s investigations standards, ensure investigations are conducted in alignment with Quality Management System requirements, and present investigative findings during audits as requested.
• Site Scheduling - The Site Scheduling team is responsible for the finite manufacturing schedule and scenario planning to evaluate production plan changes for all three drug substance factories at RTP BIO Site. This team will have global cross site/network strategy collaboration and continuously work with local management to ensure the master schedule is feasible with current or planned resources. The team is responsible for planned production orders and creation/maintenance of the master schedule, responsible for issuing and coordinating Manufacturing documentation such as master production records (MPRs) to support manufacturing operations.
• Continuous Improvement -  You will lead the CI team, facilitate and at times play the coach on process improvement projects through to completion according to global standards (BiOS, Lean, and Six Sigma Methods).  Leveraging the proven improvement methods, you will develop, implement, and track site performance metrics to reflect accurate and efficient processes that drive production improvement and operational consistency across all departments of the manufacturing site.  You will be the champion that establishes and influences a strong improvement culture to drive increased efficiency and productivity.

Who You Are

You are a strong leader that relishes the opportunities to influence and drive critical strategic operational design and change. You have a constant desire to continuously improve and have demonstrated a strong track record of leading site-wide campaigns for business transformation.

• Develop a strong improvement culture and corresponding execution plans and priorities required to drive an operational transformation for investigations, site scheduling, and continuous improvement.  Develop strong relationships with internal and external teams to ensure program effectiveness and sustainability.
• Deploy critical lean and operational excellence tools across the RTP campus in alignment with the BiOS foundational principles for Lean Leadership, People & Organization, Daily Rhythm and Schedule & Standardization (Examples: Visual Management, Leader Standard Work, VSM, OEE, OLE/OOE, Kanban, 5 Why’s, Pull systems, etc.).  Develop and establish KPIs, dashboards and system reports for site performance metrics, tracking and closure, risk and prioritization matrix as well as financial summary from the site continuous improvement programs.
• Serve in a Project Leadership role managing complex, strategic, cross-functional projects yielding 2-5% financial savings year over year.
• Directly lead the site teams for Site Scheduling and Planning, Investigations and the Industrial Engineers & OSI Practitioners to drive lean culture, performance metrics and deliver against site / global project milestones and deliverables.

Qualifications

Required Skills

• Bachelor’s Degree in Science or Engineering + at least 10 years of Biotechnology, Pharmaceutical or similar highly regulated industry including experience in operations with engagement in Operational and Business support functions.
• NOTE: An equivalent combination of education, experience, and/or relevant professional certifications m