Sr. Spclst, Planning & Scheduling

Job Description

Summary: 

Global Clinical Supply Operations is seeking a highly motivated individual to support the clinical supply operations packaging organization, including first-line leader for day-to-day operations activities.  Adherence to regulatory, global and site policies and procedures governing activities is critical. 

In addition to future state operational activities, this position is responsible for supporting the launch of a new cold chain packaging facility and for providing day to day tactical direction to the team of Clinical Packaging Technicians, ensuring that business objectives are met and that a high standard for Quality and Safety compliance is maintained.  The position will also be expected to promote behaviors of continuous improvement and ensure that the Packaging team maintains an inclusive culture that supports positive employee relations.

Core Responsibilities:

Process Execution | Continuous Improvement

• Work independently to collaborate and influence cross-functional teams including Quality/Compliance, Engineering, EHS, and Project Leads.

• Lead and support mock runs and internal audits to ensure operational readiness for the facility.

• Serve as a Subject Matter Expert (SME) to provide area/process overview information to visitors/auditors upon request.

• Author, review and approve SOPs related to operational changes.

• Author and/or participate in investigations of atypical events and clinical complaints, as needed.

• Work to prepare a room or batch for packaging activities, including the creation of appropriate Packaging documentation as needed.

• Partner with other groups, including Quality, Label Room, Distribution Center, Operations Planning, Master Planning.

• Coordinate complex packaging jobs and serve as technical contact for Packaging Technicians and Operations Planners as needed.

• Ensure correct documentation of transactions within SAP and perform pre-execution and post-execution reviews of batch documentation as per procedures.

• Lead or participate in walkthroughs of areas/processes to identify process improvements and ensure adherence to regulatory requirements.

• Execute Corrective/Preventative actions stemming from walkthrough observations and/or investigations, as needed.

• Review area alarms and log completions to ensure compliance.

• Track area performance related to Key Performance Indicators and determined root cause and trending of misses.

• Train cross-functionally to support Distribution and Labeling activities based on operating model.

Leadership | Communication

• Provide a leadership presence on the packaging floor.

• Support daily (Tier) meetings to facilitate flow of information up/down through the organization.

• Facilitate regular huddle meetings to cascade information and collect team feedback.

• Provide regular feedback and coaching to employees on work performance.

• Ensure a culture of inclusion and consistency is maintained, supporting positive employee relations at the packaging floor level within the team and site.

• Review Technician performance and system entries to ensure accuracy and compliance.

• Regularly help the team troubleshoot issues to minimize downtime and maintain product quality.

• Identify opportunities to improve the process (e.g. cycle times, ease of execution, reliability)

• Support work as needed to implement improvements (e.g. scheduling, staffing, protocol execution)

• Champion standard work to drive consistent use of best practices.

• Represent Operations on project teams as needed.

• Participate in continuous improvement initiatives across clinical supply operations.

• Assist packaging leadership team with development of objectives and ensure alignment with site goals.

• Escalate issues as needed to ensure the right support/awareness is given to issues as they arise.

• Maintain training and compliance with site safety and quality requirements.

• Participate in safety/regulatory audits (i.e. tours, topic discussion)

• Foster strong and effective safety culture on the team through actions, coaching, and prioritization.

Education:

• Bachelor’s Degree and a minimum of 4 years’ experience in Technical Operations, related Business Operations or Good Manufacturing Practice (GMP) regulated environment, with specific experience in Clinical Pharmaceutical Packaging.

Required Experience &a