Sr Director, Quality

Thermo Fisher Scientific Inc.; United States; Remote; USD 95,000 - 135,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Quality Manager to define and implement the quality strategy for their Single-Use Technologies. The role requires proven leadership skills in multi-site operations and a strong understanding of quality management systems and regulations. The successful candidate will drive a customer-centric culture while mentoring a passionate team, ensuring high-quality standards are met across all product lifecycle stages.

Qualifications

• Minimum 10 years in pharmaceutical or medical device industry, with regulated products focus.
• 5 years of leadership experience in multi-site operations.
• Experience leading audits (ISO 13485) and engaging with customers on quality matters.

Responsibilities

• Define and own the quality strategy for Single-Use Technologies.
• Champion a quality culture across all levels of the organization.
• Mentor and develop talent within the Quality organization.

Skills

Change Agent

Strategic Business Insight

Quality Management Systems

Interpersonal Skills

Quality Tools

Education

Bachelor's degree or higher in a scientific or engineering field

Tools

TrackWise

MasterControl

AGILE

SAP

LIMS

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

What You Will Do:

• Define and own the quality strategy for Single-Use Technologies, ensuring alignment with corporate and group-level objectives.
• Champion a robust quality culture across all levels of the organization.
• Drive a customer-centric culture by positioning quality as a competitive differentiator that improves customer trust, happiness, and dedication.
• Provide quality leadership across a multi-site manufacturing network.
• Serve as a key customer-facing representative, building and maintaining strong professional relationships with customer Quality counterparts.
• Navigate matrixed relationships across Thermo Fisher to ensure quality is embedded throughout the entire product lifecycle.
• Mentor and develop talent within the Quality organization; provide training and mentoring as needed.
• Lead resolution efforts for complex quality issues, ensuring clear communication to senior leadership and other collaborators.
• Apply Quality Risk Management principles to mitigate potential failure modes and ensure uninterrupted supply of high-quality products.
• Conduct advanced data analysis to identify root causes, trends, and large-scale quality improvement opportunities.
• Collaborate cross-functionally on product introductions and continuous improvement projects, integrating risk management and compliance throughout the product lifecycle.

Professional Experience:

• Minimum of 10 years in the pharmaceutical or medical device industry, with a focus on regulated products.
• At least 5 years of leadership experience leading multi-site operations.
• Strong experience leading audits (e.g., ISO 13485).
• Direct experience engaging with customers on complex quality matters.

Skills & Proficiencies:

• Proven change agent with a track record of incorporating a strong quality approach.
• Strategic business insight and a deep understanding of how quality enhances business success.
• Expertise in Quality Management Systems within a pharmaceutical or medical device context.
• Outstanding interpersonal skills, both verbal and written, with experience handling high-stakes quality blocking issues.
• Proficient in industry standards and regulations including 21 CFR Part 820, ISO 13485, and ISO 9001.
• Strong command of quality tools such as FMEA, Root Cause Analysis, Risk Assessments, and quality systems like TrackWise, MasterControl, AGILE, SAP, or LIMS.
• Training or certification in Lean/Six Sigma methodologies.

What You Will Need:

• Bachelor’s degree or higher in a scientific or engineering field.
• Familiarity with Single-Use Technologies bioprocessing, or new product introductions in pharma or med device.
• Experience in supplier quality oversight and procurement support.
• Project management experience in a regulated environment.
• Knowledge of Lean Production Systems.
• Regulatory Affairs or Quality certifications (RAPS, ASQ, etc.) are a plus.

Apply today! http://jobs.thermofisher.com

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