Description

Job Summary: 

Under the direct supervision of the Vice President, Technical Operations (US) the incumber is directly responsible for all aspects of Manufacturing and Packaging Operations within the Miramar Main and Satellite facilities, including ensuring that all work is performed in compliance with Safe Work Practices, cGMP, Standard Operating Procedures, and company policies to ensure compliance with all safety and quality regulations.  As the leader of the cross-functional Miramar Leadership Team, the main focus of responsibility is for day-to-day performance and results, developing systems and measurements to evaluate area performance focusing on delivering Supply Plan and contributing to continuous improvements in process reliability, quality, performance and cost efficiencies to facilitate improved productivity. 

Job Responsibilities:

• As Leader of the cross-functional Miramar Leadership Team manages the day to day operations by establishing site priorities and directing site activities to ensure quality products are formulated, developed, produced, and delivered to Aveva’s customers, in support of company goals and objectives.
• Builds and maintains positive relationships with the key business partners within the organization and facilitates interactions between production team and support groups
• Travel up to 15% of the time

• Provide results oriented leadership that drives continuous improvement consistent with the Operations Strategic Plan and the Production Plan, including support for R&D MFG and PKG needs as per Monthy Production Schedule.
• Prepares and administers overall Production department budget and collaborated providing input and support to overall site budget to achieve the site plan.
• Maintains cost consciousness and stresses operational efficiencies throughout managed departments.
• Oversees and directs compliance with FDA, cGMP, SOP, DEA, and other pertinent regulations and requirements.
• Plays an active role on quality management teams within the organization.
• Ensures compliance with all safety rules and regulations and creates, monitors, and maintains a safe work environment.
• Develops, nurtures, and trains staff to further departmental and organizational goals.
• Provides project management support for new and existing internal products as well as client’s products.
• Ensures project deadlines and performance standards are established and met.
• Provides technical support and problem solving for new products under development as well as existing commercial products.
• Develops organizational objectives to meet organization’s needs.
• Ensures that accurate and up to date SOP’s are in place and that all departments are in compliance with current procedures and practices.
• Directs the development and maintenance of systems and metrics to measure and evaluate both productivity and individual performance and contribution on an on-going basis.
• Sponsors and facilitates the use of systems and metrics to guide the initiation and execution of safety, quality, productivity and continuous improvement initiatives in support of the Operations Strategic Plan and Production Plan.
• Ensures team is professional and performs all work in accordance with established regulatory, compliance and safety requirements. Reviews and approves investigations and ensures systemic preventive/corrective action for all safety and compliance non-conformances are implemented.
• Develop and support a culture within the organization that promotes troubleshooting and problem solving at the team level

• Recruits, trains, develops and manages effectively the ongoing performance of their direct reports, which includes, but is not limited to:
  • Ensuring all Job Descriptions for direct reports are periodically reviewed, signed and stored  according to our  job description processes; 
  • Reviewing and updating development plans for all direct reports, ensuring that all direct reports are properly trained and qualified according to our  Training and Employee Qualification Enterprise Policy;
  • Effectively managing performance for direct reports according to the  Performance Management Program,
  • Attracting and retaining talent based on our talent management framework;
  • Scheduling regular one-on-one meetings, probationary performance reviews and mid-year performance discussions;
  • Providing regular coaching, feedback and recognition based on the expected behaviors, job description and performance on objectives; and
  • Responsible to ensure compliance of team members (direct reports) with the  Business Ethics and Compliance Program,  Quality procedures, Safety and Environment policies, and HR policies. 
  • Works as a member of a team to achieve all outcomes;
  • Leads with a  mindset that respects all cultural dimensions;
  • Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements;
  • Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion
  • All other duties as assigned.

Qualifications

Job Requirements

Education

• Undergraduate University degree in Pharmacy, Science or Engineering preferred. Master’s degree from an accredited college or university preferred. 

Knowledge, Skills and Abilities

Experience

• 15 – 20 years of management level pharmaceutical manufacturing experience. 
• An equivalent combination of education and experience may be substituted.  
• Experience with ERP and systems administration in a pharmaceutical environment preferred.