Senior Compliance Manager at Thermo Fisher Scientific

Morrisville, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalsIndustries

Requirements

Minimum of 10 years professional working experience in Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related compliance experience
At least 5 years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections
Expert Quality compliance auditor
Experience with elements of data integrity covering all areas in a pharmaceutical manufacturing environment, including production and QC laboratories
Skilled in quality investigations, root cause analysis, audit reporting and benchmark sharing with a commitment towards quality improvement
Experience in sterile manufacturing and aseptic practice (desired)
Professional auditor training/certification by an organization recognized within the pharmaceutical industry (e.g. IRCA, ASQ)
Strong foundation of pharmaceutical manufacturing and laboratory operations
Diverse experience auditing a wide range of manufacturing technologies and services in 30% or more of the following areas: Sterile drug products (liquid, lyophilized vials, prefilled syringes); Non-sterile drug products (tablets, powders, capsules, granules, softgels); Biologics cell culture (upstream and downstream); Chemicals, intermediates, API manufacturing; Packaging operations; QC laboratories (Analytical and Microbiological); IT/Computer systems validation; Clinical and commercial stage products and services; Viral vector (VVS) and microbial manufacturing (MMS); Data integrity audits
Strong communication skills

Responsibilities

Conduct internal audits of Thermo Fisher Pharma Services Group (PSG) manufacturing and Clinical Trial Division (CTD) sites to identify systemic gaps in quality/compliance
Prepare detailed audit reports to communicate observations in a meaningful and accurate way
Maintain knowledge of GMPs and stay routinely aware of revised or emerging quality regulations, trends, and industry methodologies across the globe
Promote positive Quality and leadership behaviors: creating environments for learning, harnessing lessons learned for continuous improvement, sharing standard methodologies, maintaining effective and open communication, and encouraging cross-functional partnerships
Participate in ad-hoc quality compliance projects related to auditing (e.g., detailed trending reports, data analysis, reviewing global PSG policies, preparing auditor training materials for internal/external quality auditors in the PSG network)
Holistically assess the state of quality and regulatory compliance across PSG global manufacturing/testing sites via fully independent audit program
Help minimize risk across sites and achieve successful regulatory inspections

Skills

Key technologies and capabilities for this role

GMP AuditingRisk ManagementInternal AuditsPharma GMPQuality ComplianceAudit ReportingRegulatory ComplianceData AnalysisAuditor TrainingQuality Systems

Questions & Answers

Common questions about this position

What experience is required for the Senior Compliance Manager role?

Candidates need a minimum of 10 years professional working experience in the Pharmaceutical Industry, including Manufacturing, Quality Control, Quality Assurance, CMC, Regulatory or related compliance experience, with at least 5 years aggregate experience performing audits for GMP, ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections.

What key skills are needed for this position?

Must be an expert Quality compliance auditor with experience in data integrity across pharmaceutical manufacturing environments, quality investigations, root cause analysis, audit reporting, and benchmark sharing. Experience in sterile manufacturing and aseptic practice is desired.

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

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What does the company culture emphasize in this role?

The role promotes positive Quality and leadership behaviors such as creating environments for learning, harnessing lessons learned to drive continuous improvement, sharing standard methodologies, maintaining effective and open communication, and encouraging cross-functional partnerships.

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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