Sr Director, Quality Large Molecule
Thermo Fisher ScientificSalary not specified
- Full Time
- Expert & Leadership (9+ years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, Biotechnology, HealthcareIndustries
Requirements
Candidates should possess a Bachelor’s degree in a relevant scientific or engineering field, along with a thorough understanding of national and international laws, regulations, and guidelines regarding GMP. They should have broad experience in Quality Management, including the development, establishment, and maintenance of quality systems (GXPs), and experience in interacting with authorities such as the EU and FDA.
Responsibilities
The Field Engineering Manager will work with clients to comprehensively understand and record requirements for Life Sciences clients, designing and managing internal and supplier quality programs. They will kick off and monitor managed programs, identify opportunities for additional services, conduct regular reviews with cross-functional teams, analyze program activity and provide feedback, develop plans for associate monitoring and development, and maintain SQA up to date with regulatory requirements. Additionally, they will perform qualification/technical visits at vendor sites to support vendor selection and supplier qualification.
Skills
GMP
GxPs
Regulatory Guidelines
FDA
EU Regulations
Quality Management Systems
Vendor Qualification
Auditing
Inspection
Remediation
Process Optimization
Client Requirements
SQA Services
Quality management solutions for supply chains
About SQA Services
SQA Services offers quality management solutions for complex supply chains, partnering with Fortune 500 companies across industries like aerospace, pharmaceuticals, and medical devices. The company operates globally, acting as an extension of its clients' quality teams to manage and monitor supply chain quality efficiently. SQA uses a data-driven, risk-based approach to ensure that suppliers meet stringent quality standards, which helps clients save time and money. The goal is to provide tailored solutions that adapt to the evolving quality requirements of their clients' industries.
Key Metrics
None, NoneHeadquarters
1995Year Founded
$282MTotal Funding
M_AND_ACompany Stage
Industrial & Manufacturing, Aerospace, Defense, Biotechnology, HealthcareIndustries
201-500Employees