Imagine… 2 weeks after the birth of your child you realize they aren’t meeting critical developmental milestones and after months of doctor’s appointments you are told your baby has a rare neurological disease that would impact how they would live their lives. This is the reality of parents whose children have Spinal Muscular Atrophy (SMA) and it’s the reason why we at Novartis Gene Therapy are laser focused on bringing hope and possibility to those devastated by rare genetic diseases. We use cutting-edge technology to turn promising gene therapies into proven treatments beginning with SMA but also focusing on Rett Syndrome and Friedreich’s Ataxia. Imagine the lives you could transform by joining the Novartis Gene Therapy team.
The Associate Director, Head of Operations, Oversee site operations team including Facility and maintenance, Automation and Engineering, Qualification and Validation, and Capital projects.
- 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 pro-active 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.
- Drive operational excellence and continuous improvement.
- Other related duties as assigned.
- 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.
- Experience hiring, managing, and developing technical resources in an operating GMP environment.
- Self-motivated with a strong sense of ownership in areas of responsibility, including all areas of operational leadership
- Strong interpersonal, verbal and written communication skills are essential.
- Excellent oral and written communication skills.
The level of this position will be based on the final candidate’s qualifications.
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Novartis Gene Therapies Benefit Summary:
Annual bonus, long term incentive, health insurance, paid vacation/holidays, potential flexible working arrangements (based on role) and an employee recognition program are available for this position, among many other benefits provided to employees of Novartis Gene Therapies.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.