Senior Supplier Quality Specialist *PC 518

Miltenyi Biotec Inc; East Hampshire; On-site; USD 119,000 - 162,000; Full time

Job summary

An established industry player is seeking a Supplier Quality Manager to oversee supplier qualifications and audits within the biopharmaceutical sector. This role involves managing supplier assessments, developing quality systems, and ensuring compliance with GMP standards. The ideal candidate will have extensive experience in Quality Assurance and a solid understanding of regulatory requirements. Join a dynamic team dedicated to maintaining high-quality standards and contributing to innovative solutions in the life sciences field. If you are passionate about quality management and thrive in a collaborative environment, this opportunity is for you.

Benefits

Health insurance

Vision insurance

Dental insurance

401(k) plan

Possibility of bonuses or commissions

Qualifications

• 5+ years of experience in Quality Assurance or Regulatory within the biopharmaceutical industry.
• Deep knowledge of pharmaceutical GMPs and standards for biotechnology product manufacturing.

Responsibilities

• Manage supplier quality program and perform supplier assessments.
• Develop and maintain the supplier audit program and conduct audits.
• Collaborate with QC to qualify raw materials and define testing levels.

Skills

Auditing and inspection management

Material and quality systems

Compliance and regulatory requirements

Excellent communication skills

Organizational skills

Interpersonal skills

Project management

MS Office proficiency

Education

Bachelor's Degree in Life Sciences

Tools

MS Office (Access, Excel, Word)

PowerPoint

Visio

Job description

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.