Jun 01, 2022

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

The Director, Head of Operations, will lead the site operations team including Facility and Maintenance, Automation & Engineering, Qualification & Validation, and Capital projects for our Technical Research & Development Organization (TRD).

Your responsibilities will include, but are not limited to:

• Interacts with site leadership to Develops long range strategic plans for site development.
• Plans, budgets, and drives overall site Operation activities.
• Collaborate cross-divisionally in developing the optimal operations for site. Develop and deliver on SLAs with divisions/groups locally.
• Build network within the NVS ecosystem to best position the operations and resources for the San Diego site.
• Ensures compliance of the site according to US and international regulatory agencies including OSHA and FDA.
• Oversee capital projects to upgrade or expand facilities and equipment needed.
• Review and approve critical documentation such as SOP’s, URS, FRS, Technical Specifications, and Functional Specifications.
• Drive proactive site inspection readiness programs and promotes quality and compliance culture.
• Ensures department resources are available to promptly respond to and resolve site problems as needed at all times.
• Manages third party service provider relationships; maintains a master contact list and ensures that appropriate service agreements are in place and vendors are appropriately trained and qualified.
• Establishes KPIs including staying within the budget, and ensures staff support and meet KPI’s. Takes corrective actions to mitigate performance gaps.
• Has the ability to maintain a strong leadership presence, display sound decision-making and presentation skills, and is highly adept at representing the site both internally and externally
• Efficiently synthesize information from a variety of sources proactively to identify interdependencies and leverage a solutions-focused mindset to develop options
• Drive operational excellence and continuous improvement.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What you'll bring to the role:

• Bachelor of Science degree in Engineering, Computer Science, or related technical field
• 12+ years of experience in biotech or pharmaceutical based GMP manufacturing operations including experience of facility maintenance, infrastructure, engineering, and operations management for biotech/biopharma industry.
• Advanced degree such as an MBA would be an advantage.
• Experience in the development, automation, and manufacture of gene therapy, biotech or pharmaceutical products and facilities or biotechnology is a plus.
• Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning
• Demonstrated ability to work and collaborate in cross-functional teams, research, development, manufacturing, and quality in a fast pace, dynamic team setting.
• High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
• Experience managing 3rd parties (both in-sourcing and outsourcing).
• Experience with current data integrity industry guidance and regulations.
• Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
Global Drug Development
San Diego, CA
Research & Development
Full Time
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Director, Head of Operations (Automation, Engineering, CapEx)

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