Manager Operations

United States of America, New Jersey, Branchburg

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Responsibilities

  • Provides developmental plans for direct reports and conducts on-going performance management activities.  
  • Oversees work groups which conduct equipment  and Facility validation, planning and logistics and other routine activities.  Is responsible for the accuracy, quality and timeliness of logistics activities and equipment and facilitiy validation activities. 
  • Performs and manages the qualification Process Control Systems
  • Performs and manages the qualification of utility systems (processed water, clean steam and compressed dry air)
  • Performs and manages the qualification of environmentally controlled manufacturing areas. 
  • Provides developmental plans for direct reports and conducts on-going performance management activities. 
  • Keeps leaders informed of project status, particularly of significant observations and results in critical areas.  
  • Ensures that work group performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g., OSHA, FDA, ISO). 
  • Serves as a technical resource and mentor to the members of the work group and resolves issues encountered in the logistics and planning processes to improve performance. Provides definition and plans for timely achievement of overall product or project goals and to the expeditious transfer of technologies.
  • Analyzes complex data using the required system and various data analysis software.  Leads investigations, validation deviations and forms conclusions and makes recommendations, provides or implements process improvements and document improvements.  Prepares complex reports, presentations, protocols and other documents.  Review and approve protocols, final reports and other documents associated with equipment and facility validation.
  • Documents validation/qualification and  logistics activities accurately and appropriately, and according to established formats. Writes and/or revises documents (e.g., SOPs, Variances,  Change Requests) timely and in compliance with cGMP/ QSR practices.  
  • Supervises day-to-day operations and three staff, coordinating the scheduling and execution of planning and logistics procedures. Defines and monitors project timelines, ensuring timely achievement of overall project goals and establishing priorities.  Performs supervisory functions including performance management and career development guidance for direct reports.  Responsible for providing appropriate training and development opportunities for staff. 
  • Participates in routine training activities to maintain/enhance own technical skill level and supervisory abilities.
  • Participates in managing the schedule and work assignments for order management, planning and scheduling, operations information management as well as inventory management and control.   Participates in or leads project-based activities (e.g., supply chain management, new product transfers, global information management) to support departmental goals. Maintains control of work group expenses within limits of DOA.  

Qualifications:

  • Required:
  • Bachelors Degree - Bachelors in Engineering, Biological Science, Chemistry, Biochemistry or related field.
  • 8 years relevant industry experience
  • Equivalent combination of education and work experience is acceptable.

  • Preferred:
  • Masters degree
  • 8 + years relevant industry experience

Travel requirements:

  • 10% based on business needs

Roche is an equal opportunity employer.

Manufacturing, Manufacturing > General Manufacturing