Site Controlled Substance Lead at Thermo Fisher Scientific

Swindon, England, United Kingdom

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Relevant science-based degree (e.g., Chemistry, Biology, Pharmacy, or equivalent)
Approximately 7 years of relevant pharmaceutical/biotech experience in a regulated environment (e.g., FDA, EU GMP, JP)
Demonstrated experience in running audits/inspections of domestic regulators for controlled substances
Qualified Lead Auditor
Qualified trainer, particularly for controlled drug handling
Able to communicate well with all levels of the business
Expertise in cGMP compliance for controlled substances
Proficiency with electronic tools (e.g., Trackwise, eDMS, SFLMS)

Responsibilities

Responsibility for controlled substance management for the site Controlled Substances Program (CSP)
Collaborate with controlled substances regulators such as the Home Office
Lead internal audits to support site inspection readiness and collaborate sitewide to achieve key objectives
Share knowledge through structured training, particularly for controlled drug handling
Draft, review, and approve documents such as procedures, deviations, CAPA, etc
Apply innovative tools for extracting, analysing, and interpreting QMS data to support management reporting, propose solutions to trends, and collaborate on resolutions
Drive ownership and accountability for process compliance as process owner (e.g., risk management, audits, training, change control, deviations, CAPA, supplier assurance, document lifecycle, metrics reporting)
Stay up to date with standard processes, corporate, and regulatory requirements
Provide inspiration, mentorship, and support to the team as a credible leader
Deputise for the Quality Compliance Manager when required, ensuring continuity and effective management of compliance duties

Skills

Key technologies and capabilities for this role

GMPcGMPQMSRisk ManagementAuditsCAPADeviationsChange ControlTrainingTrackwiseeDMSSFLMSSupplier AssuranceDocument ManagementMetrics Reporting

Questions & Answers

Common questions about this position

What experience level is required for this role?

Approximately 7 years of relevant pharmaceutical/biotech experience in a regulated environment such as FDA, EU GMP, or JP is required.

What education is needed for the Site Controlled Substance Lead position?

A relevant science-based degree such as Chemistry, Biology, Pharmacy, or equivalent is required.

Is this a remote position or does it require on-site work?

This is an on-site role at the Swindon site involving adherence to GMP safety standards, office work, and handling hazardous materials.

What key skills and qualifications are essential for this job?

Demonstrated experience in running audits/inspections for controlled substances, Qualified Lead Auditor status, and strong communication skills with all business levels are essential, along with proficiency in electronic tools like Trackwise and eDMS.

What does the company value in candidates for this role?

The company seeks a dedicated, innovative person valuing Quality with current expertise, passionate about enhancing QMS for cGMP compliance, who can provide inspiration, mentorship, and deputise for the Quality Compliance Manager.

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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