Associate Director, Supply Chain – Global Launch
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.
Imagine the lives you could transform by joining the Novartis Gene Therapy team.
The Associate Director, Supply Chain - Global Launch, is responsible for managing supply chain related activities to support global launches with multiple programs. This role leads cross-functional teams to ensure launch readiness in multiple markets.
- Provides cross-functional leadership for global launch activities including ensuring regulatory filings, order management and distribution and handling requirements are established in line with Supply Chain processes and systems.
- Act as the single point of accountability for market launch readiness for Technical Operations ensuring cross functional engagement and alignment.
- Oversee the Manufacturing and Supply Chain team distribution activities, this individual will also be responsible for designing all cold chain shipping and logistics to ensure that high quality medicine is delivered in a timely and compliant manner to patients around the globe.
- Partner with the GTx Regulatory and Marketing Authorization Holder to establish country specific labeling and distribution requirements that are in line with the organizations principles for all initial launch set ups by region.
- Work cross functionally with Commercial, Marketing, Regulatory and Quality to create secondary packaging in support of commercial launch for each product/program.
- Support and influence post approval filing activities within the responsible region as they relate to available supply for marketed products.
- Manage cross-functional project plan for launch readiness.
- Lead manufacturing site and function representatives to complete all required activities and to design efficient and effective product, process and procedures.
- Meet or exceed all Quality System requirements for pertinent area of management.
- Support site regulatory inspections as subject matter expert (SME) for country specific order fulfillment, distribution, packaging, and chain of custody requirements.
- Responsible for proactively communicating status, issues and actions to senior management and navigating stakeholder governance process when necessary.
- Key leader for the Manufacturing & Supply Chain team distribution activities.
- Other related duties as assigned.
- B.S. degree in engineering/science, supply chain, management, or equivalent. MBA/ relevant masters preferred.
- 7 years of direct experience in complex, multi-product high quality bio-pharmaceutical manufacturing and/or supply chain including managing logistics for temperature sensitive shipments (domestic and international).
- Strong experience with supply chain methodologies, project management systems and other planning tools.
- Demonstrated experience leading cross functional teams and complex projects, PMP is a plus.
- Strong teamwork and interpersonal skills.
- Ability to work effectively across different functions within the organization and externally with critical vendors and suppliers.
- Detailed experience and knowledge of organizational structure, workflow and operating procedures.
- Strong knowledge of accounting/financial/business analysis processes and techniques.
- Hands on experience supporting inspections with regulatory agencies plus working knowledge of the CFRs and cGMPs related to the above supply chain related responsibilities.
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.
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