Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Life Sciences, Genetic Science, Medical DevicesIndustries

Requirements

Candidates must possess a Bachelor's degree in science or engineering fields or equivalent experience, with a minimum of 15 years of professional quality experience in the Life Sciences, Medical Device, Pharmaceutical, or IVD industry. Required qualifications include a strong customer focus, the ability to implement robust quality systems like ISO 9001, ISO 13485, and MDSAP, proven team-building skills, a clear understanding of operational execution for quality assurance, and the flexibility to manage multiple complex projects simultaneously. Preferred experience includes IVD/IVDR, 510K, and GXP requirements.

Responsibilities

The Director of Quality will lead the Singapore site quality teams, developing quality system and assurance plans to support GSD and LSG businesses, ensuring alignment with internal and external quality regulations. Responsibilities include leading quality systems, strategic planning, monitoring regulations, integrating and improving the QMS, and enhancing product quality. The role involves developing a quality vision, leading and developing the site quality organization, using continuous improvement skills, establishing site-wide QA priorities, implementing and ensuring adherence to quality systems aligned with 21 CFR 820, ISO 9001, ISO 13485, MDSAP, CE-IVDD, and CE-IVDR, and collaborating with corporate, group, and divisional quality partners. Additionally, the Director will foster connections within LSG and regions, develop the continual improvement of Quality Management Systems, support New Product Introductions, collaborate with the Regulatory organization, and serve as the Management Representative for Singapore to the US FDA and Notified Bodies.

Skills

Quality Systems
Quality Assurance
QMS
21 CFR 820
ISO9001
ISO 13485
MDSAP
CE-IVDD
CE-IVDR
Continuous Improvement
CAPA
Internal Audits
NPI
Leadership
Team Development
Strategic Planning
Regulatory Compliance

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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