Specialist, Supplier Quality
Durham, NC - USA
Job Summary
Band
Level 3Job Description Summary
The Specialist Supplier Quality Assurance contributes to our SQA operations as we continue to develop and maintain supplier quality standards to ensure products are manufactured to relevant patient safety and product quality standards in line with business requirements.Job Description
Location:
- This position will be located in Durham NC and is a Hybrid role; 3 days a week on-site and 2 days a week working remotely.
- Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Key Responsibilities:
- Supports the Supplier Quality function responsible for delivering all aspects of the Supplier Quality Assurance.
- Plans manages and supports supplier audits.
- Supports Supplier Quality core processes; supplier and material qualification for new and existing suppliers quality agreements quality risk assessments supplier maintenance/periodic assessments supplier monitoring SPEC creation and revision supplier complaints and supplier change notifications.
- Approves and maintains supplier and material data in the appropriate electronic systems (quality and inventory management).
- Addresses supplier quality related issues and facilitates the escalation of unresolved supplier quality issues within assigned projects and suppliers.
- Addresses supplier quality related issues and facilitates the escalation of unresolved supplier quality issues within assigned projects and suppliers.
- Supports the communication to all levels within the organization on quality related topics.
- Identifies nonconforming events facilitates supports reviews and approves supplier complaints performs root cause analyses and identifies solutions with cross-functional teams.
- Supports resolution and closure of Supplier Quality related corrective and preventive actions.
- May assist with the collaboration with the Global Strategic Sourcing team on new supplier introduction and supply chain initiatives.
- Monitors and regularly reports supplier product quality and performance to appropriate QA Leadership and Business Partners.
- Other related duties as assigned.
Essential Requirements:
- Bachelors Degree in scientific discipline with 5 years experience in Biotech/Pharmaceutical industry or 4 years experience in Biotech/Pharmaceutical industry with at least 2 years within Novartis Gene Therapies.
- Understanding of common biologics and sterile chemical materials manufacturing processes is a plus.
- Hands on knowledge of quality management and business systems for managing suppliers and materials.
- Basic knowledge of GMP (US EU and APAC) as well as ISO standards with regards to material and service providers.
- Ability to demonstrate high attention to detail multi-tasking and organization ability.
- Ability to work in a diverse and dynamic environment.
- Good communication and interpersonal skills.
- Proficiency in and knowledge of MS Office tools quality management systems (e.g. Supplier Record and Audits) and Document Management systems
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $89600 and $166400 per year.
The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health life and disability benefits a 401(k) with company contribution and match and a variety of other addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. 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 strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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 call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
Collaboration Communication Skills Data Integrity Dealing With Ambiguity Digital saviness Leadership Operational Excellence Problem Solving Skills Regulatory Requirements knowledgeRequired Experience:
IC
About Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.