Quality Director, Purification & Pharma Analytics (PPA) at Thermo Fisher Scientific

Bedford, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Life SciencesIndustries

Requirements

Bachelor’s degree or higher in Science, Engineering, or a related field (or equivalent experience)
10+ years of experience in the Pharmaceutical, Biotech, or Medical Device industries with regulated products
5+ years leading multi-site or complex organizations in Quality or Operations
Consistent record of successful audit/inspection management (FDA, ISO, or equivalent)
Experience in customer-facing roles, leading complex quality challenges
Passion for championing an inclusive, customer-focused quality culture
Business insight: ability to link quality performance to business outcomes
Deep knowledge of Quality Management Systems, compliance standards (21 CFR Part 820, ISO 13485/9001), and quality tools (FMEA, RCA, Risk Analysis)
Strong communication skills—able to engage, collaborate, and encourage at all levels
Experience with enterprise quality systems (TrackWise, Agile, SAP/E1, LIMS or equivalent)
Training or certification in Lean/Six Sigma methodologies
Preferred Qualifications
Familiarity with Chromatography and Purification Solutions for Bioprocessing or Pharmaceutical Analytics
Supplier quality management and procurement oversight
Project management experience
Knowledge of Lean Production Systems
Professional certifications (RAPS, ASQ, Six Sigma Black Belt)

Responsibilities

Establish and lead Quality strategy for Purification and Pharma Analytics (PPA), ensuring alignment with Bioproduction Group and Company objectives
Develop a culture emphasizing quality, promoting involvement and responsibility throughout the multi-site PPA network, integrating quality into all decisions and procedures
Be an advocate for the customer: build strong, collaborative relationships with customer Quality counterparts, understanding their needs and translating them into continuous improvement initiatives
Lead through collaboration: manage matrix relationships across R&D, Operations, and Commercial teams to ensure end-to-end quality across the product lifecycle
Coordinate compliance excellence by ensuring readiness for regulatory inspections (ISO 13485/9001, etc.), audits, and industry standards
Solve with diligence and creativity: apply risk management, sophisticated data analytics, and root cause problem-solving to prevent issues and enable product reliability
Develop and empower talent: mentor and coach a diverse team, building future leaders in Quality
Advance innovation: partner on new product introductions and continuous improvement projects, ensuring quality is crafted into processes and products from the beginning
Uphold meticulous criteria for chromatography and purification products (e.g., POROS and CaptureSelect resins) vital for large-scale biologics and vaccine production
Coordinate quality for advanced contaminant and impurity testing solutions (e.g., rapid molecular assays, sample prep, and automation tools) that enable safe bioproduction

Skills

Key technologies and capabilities for this role

ISO 13485ISO 9001Risk ManagementData AnalyticsRoot Cause AnalysisQuality StrategyRegulatory ComplianceTeam LeadershipCustomer CollaborationStrategic Planning

Questions & Answers

Common questions about this position

What is the location for this role?

This role will be based in Bedford or Chelmsford, MA.

What education and experience are required for this position?

A Bachelor’s degree or higher in Science, Engineering, or a related field is required, along with 10+ years of experience in the Pharmaceutical, Biotech, or Medical Device industries with regulated products, and 5+ years leading multi-site or complex organizations in Quality or Operations.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does the company culture emphasize for this role?

The role focuses on driving a customer-focused quality culture, promoting involvement and responsibility throughout the multi-site network, and championing an inclusive, customer-focused quality culture.

What makes a strong candidate for this Quality Director position?

Strong candidates will have a proven record of successful audit/inspection management (FDA, ISO, or equivalent), experience in customer-facing roles leading complex quality challenges, and the ability to mentor and develop talent while advancing innovation.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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