Director of Quality, Bioproduction & Pharma Analytics

ThermoFisher Scientific; Bedford (MA); On-site; USD 160,000 - 240,000; Full time

Job summary

Thermo Fisher Scientific in Bedford, MA is seeking a Director of Quality to lead strategic quality initiatives across the PPA network, aligning with group and corporate goals. You will drive a robust quality culture, manage multi-site relationships, and partner with SMEs to deliver industry-leading product quality.

The role focuses on preventing risk with Quality Risk Management, data-driven problem solving, and cross-functional collaboration with R&D, Manufacturing, and Vendors to ensure

Qualifications

• Bachelor's degree or higher in Science, engineering disciplines or similar fields.
• 10+ years of experience in Pharmaceutical or Medical Device Industry - supporting Regulated Products.
• At least 5 years of experience managing/leading a multi-site organization.
• Audit (ISO13485 or similar) or inspection (FDA or similar) management experience.
• Customer facing experience.

Responsibilities

• Define the Quality strategy for the PPA products in alignment with Group and Corporate goals. Ensures adequate deployment and execution of such strategy.
• Drive with intensity a robust quality culture across the organization.
• Provide Quality leadership for the PPA multi-site network.
• Manage matrix relationships within Thermo Fisher to ensure all product value stream touch points are aligned to deliver Quality products and processes.
• Drive resolution to quality issues as needed and communicates internally to senior leaders and to diverse audiences in an effective manner.
• Apply Quality Risk Management to prevent risk of failure modes that impactsupply of consistent supply of Quality PPA products.
• Conduct advanced data analyses to determine quality problems and to identify larger scale quality improvements.
• Participate in cross functional team projects (R&D,Mfg, Vendors, etc).

Skills

Quality leadership

Regulatory knowledge

Quality management

Cross-functional collaboration

Communications

Lean Sigma/Six Sigma

Audits/Regulatory inspections

Procurement oversight

Education

Bachelor's degree

Tools

TrackWise

AGILE

E1/SAP

LIMS

Job description

Thermo Fisher Scientific in Bedford, MA is seeking a Director of Quality to lead strategic quality initiatives across the PPA network, aligning with group and corporate goals. You will drive a robust quality culture, manage multi-site relationships, and partner with SMEs to deliver industry-leading product quality.

The role focuses on preventing risk with Quality Risk Management, data-driven problem solving, and cross-functional collaboration with R&D, Manufacturing, and Vendors to ensure