Senior Supplier Quality Specialist *PC 518

Description

Your Tasks:

This position is primarily responsible for managing suppliers to ensure they are appropriately qualified to provide materials and/or services, including initial and periodic assessments of new and existing suppliers. The role also involves developing, managing, and maintaining a supplier audit program, conducting supplier audits, and overseeing all aspects of the Internal Audit Program.

Essential Duties and Responsibilities:

1. Manage the supplier quality program, perform qualification or periodic assessment of suppliers, and assign status to the suppliers.
2. Manage and drive Supplier Assessment Questionnaires, Statements, Supplier Quality Agreements, Supplier evaluation forms, and risk assessments.
3. Manage, drive, and review supplier change notifications, supplier complaint programs, deviations/OOS/CAPAs related to suppliers/materials.
4. Write and revise SOPs as needed, review and approve cGMP documentation including procedures, protocols, reports, CAPAs, technical data, and risk assessments related to suppliers/materials.
5. Collaborate with QC and other departments to qualify raw materials and define testing levels.
6. Develop, manage, and maintain the supplier audit program and conduct supplier audits.
7. Manage all aspects of the audit program and conduct audits.
8. Maintain a list of approved materials and suppliers, manage supplier files and documents, and oversee supplier status.
9. Work with the quality team to develop and maintain effective Quality Systems and procedures that comply with GMP standards, regulations, and guidelines.
10. Act as an SME during regulatory inspections and client audits, liaise with corporate teams, lead validation improvement projects, and support GMP knowledge sharing among employees.
11. Manage Raw Material Review Board.
12. Perform other duties as assigned.

Requirements:

• Bachelor\’s Degree in Life Sciences or related field; minimum of 5 years of experience in Quality Assurance, Quality Control, or Regulatory within the biopharmaceutical industry, or a combination of education and experience.
• Experience in aseptic processing and cell therapy.
• Deep knowledge of pharmaceutical GMPs (US and EU) and standards for biotechnology product manufacturing.
• Experience supporting FDA inspections, EU regulators, and supplier audits.

Skills:

• Auditing and inspection management, material and quality systems, compliance, and regulatory requirements.
• Excellent communication, organizational, and interpersonal skills.
• Ability to manage staff and projects effectively.
• Capable of handling variable workloads under tight deadlines.
• Proficiency in MS Office, including Access, Excel, Word; knowledge of PowerPoint and Visio is a plus.

Physical Demands:

Regularly required to stand, walk, sit, lift, and use eye/hand/foot coordination. Reasonable accommodations may be provided for disabilities.

Working Environment:

Primarily performed in an office setting.

Compensation and Benefits:

Base salary range: $119,200 – $161,300/year, based on various factors. Benefits include health, vision, dental insurance, 401(k), and possibly bonuses or commissions.

Miltenyi Biotec is an EO Employer and participates in E-Verify. We are committed to equal opportunity employment and diversity.

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