Supplier Quality Senior Specialist

Scorpion Therapeutics; Harvard (MA); On-site; USD 90,000 - 108,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) and other insurance

Job summary

Scorpion Therapeutics in Devens, MA is seeking a Senior Supplier Quality Specialist to support GMP/GDP vendor and material management programs at the Devens Biologics site, including qualification, change management, and non-conformance resolution.

You will qualify and manage GMP/GDP vendors, oversee starting materials lifecycle, assess SCNs, and support CAPA and supplier audits. Strong communication and collaboration across functions are essential.

Qualifications

• The candidate holds a B.S. in science/engineering/biochemistry or related field.
• At least 4+ years in a regulated biopharmaceutical environment.
• Practical knowledge of US/EU cGMP and ISO standards.
• Excellent written and verbal communication; attention to detail and collaboration.

Responsibilities

• Qualify and manage GMP/GDP vendors and maintain the Approved Vendor List.
• Manage lifecycle of starting materials including qualification and reduced testing.
• Assess SCNs and manage changes in the BMS change management system.
• Support deviations, SCAR, and CAPA for nonconforming materials/services.
• Review SOPs, documents, agreements, qualifications, and forms.
• Oversee on-site service vendors with QA Operations.
• Identify quality risks and notify management as appropriate.
• Collaborate cross-functionally and support external audits.

Skills

US/EU cGMP

ISO standards

SAP

Veeva

Syncade

Attention to detail

Communication

Education

B.S. in science/engineering/biochemistry or related field

Tools

SAP

Veeva

Syncade

Job description

Position Summary

The Supplier Quality Senior Specialist supports the GMP/GDP Vendor and Material Management programs at the Devens Biologics site, including vendor and material qualification/management, change management, and supplier non-conformance reporting and resolution.

Key Responsibilities

• Qualify and manage GMP/GDP vendors: assess vendors, create/revise quality agreements, maintain Approved Vendor List.
• Manage lifecycle of starting materials: material qualification/requalification, reduced testing, direct dispense.
• Assess supplier change notifications (SCN) and complete required actions in the BMS change management system.
• Support deviations, Supplier Corrective Action Requests (SCAR), and CAPA for nonconforming vendor materials/services.
• Review SOPs, technical documents/reports, agreements, qualifications, and forms.
• Oversee on-site service vendors in collaboration with business owners and QA Operations.
• Identify quality and business continuity risks and notify management as appropriate.
• Collaborate cross-functionally; may represent the team on supplier/material initiatives and support external audits.

Qualifications & Experience

• B.S. in science/engineering/biochemistry or related field (or equivalent education/experience/training).
• 4+ years in a regulated biopharmaceutical environment.
• Practical knowledge of US/EU cGMP and ISO standards.
• Familiar with SAP, Veeva, Syncade.
• Strong attention to detail, accountability, collaboration; excellent written/oral communication.

Compensation & Benefits (as stated)

• Devens, MA: $89,530–$108,490; additional incentive opportunities may apply.
• Health coverage; wellbeing programs; 401(k) and other insurance/disability/life benefits.