Supplier Quality Specialist

Job description

Job Description

• Support the audit function for vendors, suppliers, service providers and contracts. Assists with supplier qualification activities of new and current suppliers in support of Clinical and Commercial Manufacturing activities. • Maintain the Supplier Quality program, policies, and procedures ensuring that performance and quality of the of the program conform to established standards, such as QSR/GMP, Novartis Quality Modules and policies and procedures • Coordinate / Support the communication of the audit schedule and executing to plan as required by local procedures and regulatory requirements. • Conducts Supplier Quality Audits in accordance with Novartis Morris Plains Audit Plan. Travel is approximately 30%. Maintain adherence to the supplier audit schedule and in line with Quality System requirements. • Provides written reports and observations in a timely manner and assure correctives are adequate and timely. Support the AQWA FURP and QARP Coordination for the Morris Plains facility as needed with external audits. • Maintain supplier monitoring program for all commercial suppliers and provide feedback to sup-plier on a routine basis. • Assists with ensuring site quality metrics are compiled and submitted per established deadlines for the Novartis Dashboard and Site Management Reviews. • Initiates, reviews and approves Deviations, CAPA’s, change controls, Raw Material Specifications and any other site/product related documents in support of the Novartis Morris Plains facility ensuring adequate levels of documentation are adequate and compliant to existing procedures. • Write, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), specifications,), as needed. • Coordinate / Support the Supplier Quality Review Board and Supplier Quality Vendor Changes meeting and the approval process for new vendors / materials. • Lead / participate on quality manual implementation teams in area of technical expertise as required.
Posting Title

Supplier Quality Specialist

Desired profile

Minimum requirements

Bachelors or higher in Chemistry, Pharmacy, Microbiology or another related science. English: fluent in reading, speaking, and writing. Additional language(s) preferred. Minimum: 5+ years GMP manufacturing and/or QA related experience, at least 3 years of which are in the area of Sup-plier Quality. Preferred: 7+ years in a medical device/ pharmaceutical manufacturing environment or applicable industrial experience. Applicable Certifications (i.e. ASQ certified like Certified Quality Auditor (CQA), or Certified ISO 9000 Assessor (RAB).
Job Type

Full Time
Country

USA
Work Location

Morris Plains
Functional Area

Quality
Division

Novartis Technical Operations
Business Unit

NTO BTDM
Employment Type

Regular
Company/Legal Entity

Novartis Pharmaceuticals
EEO Statement

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 any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.