Senior Manager Quality Operations and Systems

Plainville, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceutical Manufacturing, Gene Therapy, Contract Development and Manufacturing Organization (CDMO)Industries

Requirements

Candidates must possess a Bachelor's degree in a scientific or technical field and have over 10 years of experience in Quality Assurance or leadership roles within biologics, pharmaceuticals, or cell/gene therapy. A strong understanding of 21 CFR, ICH Q9/Q10, ISO-14644, GAMP5, ASTM-E2500, and EU regulations is required, along with proven success managing regulatory inspections and hands-on experience with audits, deviation investigations, and GMP batch record review. Demonstrated ability to build and lead effective teams is also necessary.

Responsibilities

The Senior Manager will guide and empower a team of professionals in Quality Operations and Systems, supporting GMP manufacturing and warehouse operations. Responsibilities include ensuring inspection readiness and regulatory compliance across site quality systems, leading Supply Chain Quality functions, and developing a culture of quality through policies and procedures. The role involves establishing real-time quality oversight for manufacturing events, tracking key performance indicators, representing the site during regulatory inspections and client visits, and driving risk management initiatives. Additionally, the manager will collaborate cross-functionally on continuous improvement projects and serve as a strategic partner to clients, addressing quality-related inquiries.

Skills

Quality Operations

Quality Systems

GMP

Leadership

Team Development

Innovation

Process Improvement

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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