Sr Director, Quality
Sr Director, Quality
Posted on :
26-06-2025
Employer Active
1 Vacancy
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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:
- Bachelors 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!
Accessibility/Disability Access
Thermo Fisher Scientific provides accessibility services for job seekers needing accommodations during the application process. This includes help for hearing vision mobility or cognitive impairments.
- This phone line is for disabled job seekers needing application assistance. Messages for other issues wont be answered.
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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