Specialist, Supplier Quality

Novartis • Durham, CA

2d • Hybrid

About The Position

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.

Requirements

• Bachelor’s 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

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.

Benefits

• 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 benefits.
• In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees