Senior Supplier Quality Specialist *PC 518

Your Tasks:

This position is primarily responsible for managing suppliers to ensure they are appropriately qualified to provide materials and/or service, which includes the initial and periodic assessment of new and existing suppliers. This position is also responsible for developing, managing and maintaining a supplier audit program which includes conducting supplier audits and managing all aspects of the Internal Audit Program.

Essential Duties and Responsibilities:

• Manage the supplier quality program, perform qualification or periodic assessment of suppliers and assign status to the suppliers.
• Manage and drive Supplier Assessment Questionnaire, Statements, Supplier Quality Agreements, Suppler evaluation forms and risk assessments.
• Manage, drive and review supplier change notifications, supplier complaint program and deviations/OOS/CAPAs relating to suppliers/materials.
• Write and revise SOPs, as needed and review and approve cGMP documentation including procedures, protocols, reports, CAPAs, technical data and risk assessments relating to suppliers/materials.
• Work jointly with QC and Functional departments to qualify raw materials and defining the testing level for the material.
• Develop, manage and maintain supplier audit program and conduct supplier audit.
• Manage all aspects of audit program and conduct audits.
• Maintain a list of approved materials and suppliers, maintain files and documents for suppliers and manage supplier Status.
• Collaborate with the quality team in the development, establishment and maintenance of effective Quality Systems and procedures (e.g., change control, training, audit, deviation and CAPA) that complies with applicable GMP standards, regulations and guidelines.
• Act as an SME during regulatory inspections and client audits. Liaise with corporate team to ensure corporate requirements are met. Take a proactive role for continuous improvement and lead validation improvement projects. Support and coach employees from a GMP knowledge perspective.
• Manage Raw Material Review Board.
• Other duties as assigned.

Requirements:

• Bachelor's Degree Life Sciences or related; A minimum of 5 years of related biopharmaceutical industry experience within Quality Assurance, Quality Control, or Regulatory; Or a combination of education and experience.
• Experience in aseptic processing and cell therapy.
• In-depth knowledge and full understanding of pharmaceutical GMPs (US and EU). A clear understanding of standards of practice used in the manufacture of biotechnology products.
• Experience with effectively supporting FDA inspections, EU regulators and supplier audits.

Skills:

• Auditing and Inspection Management, Material System, Quality Systems, Compliance Quality Agreements (internal/external customer and supplier relationships), Global Regulatory Requirements, Product Complaint Management, and Batch Record Management.
• Excellent verbal, written, interpersonal, organizational and communication skills.
• Demonstrated ability to manage staff and projects, both directly and indirectly.
• Can manage variable workloads with demanding timelines.
• Knowledge of MS Office, including Access, Excel and Word.
• Knowledge of PowerPoint and Visio a plus.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk, sit, life and/or move. While performing the duties of this job, the employee is regularly required to use eye/hand/foot coordination.

Working Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in an office environment.

The anticipated base salary range has been established at $119,200 - $161,300/year. The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialization, skills, abilities, and training. The above salary range represents the Company's good faith and reasonable estimate of the range of possible compensation at the time of posting. In addition to your salary, the Company offers a comprehensive benefits package including health, vision, and dental insurance, plus a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions are eligible for additional forms of compensation such as bonuses or commissions.

Miltenyi Biotec, Inc is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.