Senior Quality Systems & Compliance Specialist

NCBioImpact; Sanford (NC); Sur place; USD 83 000 - 118 000; Plein temps

Avantages offerts par ce poste

Medical, Dental and Vision Insurance

401(k) match and company contribution

Company paid life insurance

Annual Corporate Bonus and Quarterly H

Long Term Incentive Plan

Company fleet vehicle

Referral bonus program

Résumé du poste

Astellas is seeking a Senior Specialist for Quality Systems & Compliance in an on-site role at the Sanford, NC site. You will support supplier quality management, vendor changes, supplier audits, and compliance programs, ensuring alignment with FDA/ICH standards and inspections readiness.

Qualified candidates will have a BA/BS with 10+ years or an MS with 8+ years in a related quality function in a regulated industry, plus extensive knowledge of cGMPs and regulatory guidelines.

Qualifications

• BA/BS or equivalent in related scientific or technical discipline with 10+ years relevant experience.
• MS degree with 8+ years; 4+ years in a regulated quality function.
• Knowledge of US CFR, ICH guidelines and global regulatory requirements.
• Strong verbal and written communication skills; highly organized.
• Advanced computer skills: Word, Excel, Access, Adobe Acrobat, SharePoint.
• Self-motivated; able to manage multiple tasks and deadlines.

Responsabilités

• Establish and maintain expert knowledge on quality systems and regulatory requirements.
• Communicate regulatory changes to functional groups and ensure action.
• Guide cross-functional discussions on deviations and change controls.
• Drive continuous improvement in quality assurance and regulatory readiness.
• Oversee vendor change notices and related change controls.
• Support audits, inspections and inspection readiness activities.
• Prepare audit reports and communicate results to stakeholders.
• Maintain Approved Supplier List and vendor lifecycle documents.
• Contribute to pre-approval and regulatory inspection activities.

Connaissances

Regulatory knowledge

Communication skills

Cross-functional collaboration

Self-motivation

MS Office proficiency

Formation

BA/BS or equivalent in related scientific or technical discipline

MS degree with 8+ years experience; 4+ years in quality function

Outils

MS Word

MS Excel

MS Access

Adobe Acrobat

SharePoint

Description du poste

Astellas is seeking a Senior Specialist for Quality Systems & Compliance in an on-site role at the Sanford, NC site. You will support supplier quality management, vendor changes, supplier audits, and compliance programs, ensuring alignment with FDA/ICH standards and inspections readiness.

Qualified candidates will have a BA/BS with 10+ years or an MS with 8+ years in a related quality function in a regulated industry, plus extensive knowledge of cGMPs and regulatory guidelines.