Sr. Manager, Operations Management

Job Summary

The Sr. Manager, Operations Management is the site primary contact for daily operations activities at the Northridge, CA, location, and coordination of efforts between all Cell Solutions sites. The Sr. Manager, Operations Management is the point person for interfacing with many external parties and internal stakeholders to ensure optimal performance at all Cell Solutions sites. The Sr. Manager, Operations communicates all operating policies and/or issues at department meetings; contributes operations information and recommendations to strategic plans and reviews; prepares and completes action plans; implements production, productivity, quality, and customer-service standards; resolves problems; identifies trends and works to implement corrective and preventative action plans brought forward from internal audits by the Quality team. The Sr. Manager, Operations Management supervises personnel at the Northridge location and provides guidance to the other Cell Solutions sites including Warehouse, Facilities, Equipment, and EHS&S.

Essential Responsibilities: •    Manages projects as needed and as assigned, assumes responsibility for management of technical or administrative projects critical to the success of the organization at the sites. Takes a leadership role and obtains cooperation and support from applicable management and staff from different departments to accomplish completion of projects. •    Assists with development and writing of SOPs and work instructions. •    Working with the Facilities team, ensures that Preventative Maintenance (PM) work is scheduled by the device manufacturer’s field service engineers as required and proper sticker/labeling of completion of PM work is applied to appropriate devices.  •    Involved in review and ownership of SOPs/Change Controls for the site in conjunction with department leaders to make sure that they meet internal objectives and accurately describe the process and meet client requirements as applicable.   •    Manages relationships with vendors, including compliance and dispute resolutions.   •    Works with facility management to include: Interfacing with personnel on all building issues including maintenance and cleaning; Interacting with security personnel in matters related to staff and donors/patients; Ensuring all COVID protocols are adhered to throughout the site. •    Serves as a resource to Facilities team members, ensuring that the site meets expected maintenance and service requirements for the facility and equipment used at the site.  •    Ensures all necessary equipment is maintained in good working order and is up to date on calibrations and cleaning. •    Drives collaboration across all sites ensuring all team members are updated on any changes that may affect the way they work at their site. •    Leads the Environmental Health, Safety, and Sustainability initiatives for the site and communicates to other site leads to ensure consistency with all policies and procedures. •    Responsible for oversight of the Warehouse and Materials Management and maintaining inventory support. •    Assists attracting, hiring, training, and supervising operations staff to support the distribution of products and equipment.   •    Performs all assigned responsibilities in accordance with all quality programs and with internal SOPs and Current Good Manufacturing Practices (cGMPs). •    Works with Company corporate administrative staff to develop, revise, and review SOPs (Standard Operating Procedures) to meet State, Federal, and AABB guidelines as well as the Company’s quality program plan.

Job Qualifications

•    Requires Bachelor’s degree in life sciences, operations, medical technology or a related discipline, or equivalent combination of related education and experience. •    At least 5 years of supervisory/management experience. •    A minimum of 5 years of Warehouse, Facilities, Equipment and EHS&S experience, or combination of, preferably in a regulated GMP environment.  •    Experience with current Good Laboratory Practices, and/or current Good Clinical Practices and/or current Good Manufacturing Practices a plus.  •    Experience with Environmental Health, Safety, and Sustainability. •    Knowledge of IQ/OQ/PQ. •    Ability to work in an automated, computerized environment and operate a personal computer; expertise in word processing and the use of spreadsheets; proficiency in Microsoft Office 365 applications including Outlook, PowerPoint, Word, and Teams. Experience with Microsoft Access, Excel, Smartsheet and Visio is preferred. •    Knowledge of human cells, tissues, and cellular and tissue-based products (HCT/P) practices, procedures, and theories is a plus.