Top 71 Senior quality auditor Jobs in Wilmington, De

Associate Director, GxP Quality Auditor
Cabaletta Bio —Philadelphia, PA
- 5 years
- Bachelor's degree
- Budgeting
- Health insurance
- Paid time off
Senior Billing Supervisor
Contact Government Services, LLC —Philadelphia, PA
- $91,800 - $132,600 a year
- Full-time
- Hybrid work
- Microsoft Outlook
- Mid-level
- Office
- Health insurance
- Dental insurance
Quick Apply
Senior Auditor
Contact Government Services, LLC —Philadelphia, PA
- $80,000 - $150,000 a year
- Full-time
- Hybrid work
- CPA
- 5 years
- Analysis skills
- Health insurance
- Dental insurance
Quick Apply
Sr Testing and Quality Engineer
Waters Corporation —New Castle, DE
- $92,000 - $153,000 a year
- Oracle
- Engineering
- Senior level
Senior Supplier Quality Engineer - Exton, PA
dsm-firmenich —Exton, PA
- Microsoft Outlook
- 5 years
- Bachelor of Science
- Health insurance
- Paid time off
Senior Treasury Analyst
UHS of Delaware, Inc. - Corporate Office —King of Prussia, PA
- Full-time
- Hybrid work
- Office
- 3 years
- Bachelor's degree
- Health insurance
- Dental insurance
Senior Manager, Carrier Strategy & Performance
Veho —Philadelphia, PA
- $130,000 - $150,000 a year
- Full-time
- 7 years
- Analysis skills
- Contracts
- Health insurance
- Dental insurance
Quick Apply
Senior Accountant – Employee Benefit Plan Auditor
Belfint Lyons & Shuman —West Chester, PA
- Microsoft Excel
- CPA
- Mid-level
- Flexible schedule
Senior Manager of Operations
Waters Corporation —New Castle, DE
- $133,500 - $222,500 a year
- Bachelor of Science
- Engineering
- Assembly
Internal Audit Manager (must sit 1-2 days in Wayne, PA office)
Radian —Wayne, PA
- $85,000 - $122,000 a year
- Full-time
- Office
- 8 years
- Bachelor's degree
- Health savings account
- Employee stock purchase plan
Audit Analyst
Independence Blue Cross —Philadelphia, PA
- Hybrid work
- Bachelor of Science
- Mid-level
- Office
Dir, Quality Assurance
West Pharmaceutical Services —Exton, PA
- Hybrid work
- Background check
- Senior level
- Leadership
- Relocation assistance
8d
Senior Auditor (US) - Compliance
TD Bank —Wilmington, DE
- $64,820 - $97,220 a year
- Full-time
- Microsoft Excel
- CPA
- Writing skills
- Health insurance
- Paid time off
Senior Underwriting Assistant
Risk Specialists Companies Insurance Agency, Inc. —Philadelphia, PA
- $59,000 - $68,500 a year
- Email
- Microsoft Excel
- Computer literacy
- Writing skills
- Health insurance
Quick Apply
Senior Accountant
Wheeler Wolfenden and Dwares, CPAs —Wilmington, DE
- CPA
- Mid-level
- Analysis skills
- On-the-job training
Regulatory Affairs Specialist
IDE Group —Philadelphia, PA
- Engineering
- Analysis skills
- Manufacturing
- Employee assistance program
Associate Director, Regulatory
University of Pennsylvania —Philadelphia, PA
- $105,500 - $130,000 a year
- Full-time
- Hybrid work
- Background check
- 7 years
- Customer service
- Health insurance
- Dental insurance
Risk Analyst
Janney Montgomery Scott LLC —Philadelphia, PA
- Full-time
- Hybrid work
- Writing skills
- Research
- Mid-level
- Paid parental leave
- Paid time off
Senior Accountant
Foundation for Catholic Education —West Chester, PA
- Writing skills
- Mid-level
- Office
IT Audit Supervisor
WSFS Bank —Philadelphia, PA
- $92,869 - $152,569 a year
- Full-time
- CPA
- Office
- 8 years
- Paid parental leave
- Health savings account

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Associate Director, GxP Quality Auditor

Cabaletta Bio
Philadelphia, PA

Apply Now

Job Details

Benefits

Stock options
Health insurance
Paid time off

Qualifications

Biotechnology
GxP
Incident Escalation
Bachelor's degree
Quality assurance experience within pharmaceutical industry
Biomedical regulatory compliance
Managing projects
Clinical quality assurance standards
Cross-functional collaboration
Escalation handling
Cross-functional communication

Full Job Description

About the Position

Reporting to the Audits Director, the Associate Director, GxP Auditor is an integral member of the Quality and Compliance team. The GxP Auditor is responsible for planning and conducting scheduled quality audits on behalf of Cabaletta. This individual will also act as a Subject Matter Expert (SME) for GxP auditing, quality projects and will be responsible for supporting implementation and management of the Quality Management Auditing system. The individual is responsible for independently managing quality/GxP auditing deliverables scheduled across Cabaletta.

Responsibilities Include

Function as a Quality/GxP auditor of both external CDMOs and clinical sites, and internal laboratory operations.
Implementation of the global audit strategy, aligning with organizational goals and regulatory requirements.
Perform audits across various departments and functional areas.
Conduct risk assessments to identify potential areas of concern and develop appropriate audit plans and procedures.
Review and assess the effectiveness of internal controls, making recommendations for improvement to mitigate risks and strengthen processes.
Collaborate with cross-functional teams, including finance, operations, compliance, and legal, to ensure audit findings are addressed and resolved.
Stay up to date with industry developments, regulatory changes, and emerging risks to anticipate potential impact on the organization.
Conduct investigations into allegations of fraud, unethical practices, or non-compliance, and recommend appropriate actions to address such issues.
Prepare comprehensive audit reports, including findings, recommendations, and action plans for management and key stakeholders.
Foster a culture of compliance and ethical behavior throughout the organization, providing training and guidance to employees on audit-related matters.
Responsible for leading, conducting, and documenting investigations relating to audit findings noted internally.
Utilize root cause analysis tools, critical thinking, and interviewing techniques to determine the root and contributing causal factors of noted findings.
Will offer recommendations to correct and/or prevent recurrence through CAPA design from the root cause conclusion of the investigation.
For both internal and external observations monitor the implementation of associated corrective and preventative actions through collaboration, teamwork and influence.
Coordinate and deliver audit logistics and deliverables. They will execute audits (remote or onsite) based on experience, Cabaletta requirements (as defined by policy/procedure).
Ensure audits are performed within budget and according to plan.
Facilitate post-audit debriefs with internal stakeholders within defined timeframes ensuring clear communication of audit findings.
Produce draft and final versions of audit plans, reports and summaries within defined timeframes and accordance with internal policies / procedures.
Promote continual improvement regarding stakeholder satisfaction with emphasis on Quality/GxP auditing services.
Stay current with advances and technological changes in Quality/GxP services within the biotech industry and promote those that will increase effectiveness and knowledge.
Maintain a comprehensive understanding of regulatory requirements and ICH (International Council for Harmonization) guidance.
Will work to ensure the audit practices and procedures comply with all applicable internal and external policies procedures, and industry best practices. Develop/optimize new and existing processes to maintain and improve quality/results within the audit function.
Provide coaching and/or training to Cabaletta peers on quality-related matters and audit performance.
Will administer both paper and electronic systems used to manage the supplier qualification processes within Cabaletta Bio.
With input from the Quality team, prepare both internal and external audit plans and schedules. Will present associated quality metrics to the Quality team.
Performs other administrative/managerial duties as required.

Required Qualifications

Minimum bachelor’s degree in any scientific discipline.
A minimum of 5-7 years of biopharmaceutical experience including a minimum of 3 years of GxP auditing in a regulated environment focused on quality, with CGT preferred.
Excellent knowledge of GxP regulatory requirements.
Experience using electronic Quality Management Systems.
Auditor certification, preferred.
Ability to manage multiple projects in a fast-paced environment.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
Ability to understand when issues require escalation to Senior Quality Management.
Must be detail oriented; must be precise and organized in handling of documents. Solid organizational skills required; must be able to prioritize multiple tasks.

How to Apply

Please click the link at the bottom of the posting to submit an application.

Benefits

Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.

Equal Opportunity Employer

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Apply Now

Refine Your Search

senior quality auditor jobs in wilmington, de

Associate Director, GxP Quality Auditor

Senior Billing Supervisor

Senior Auditor

Sr Testing and Quality Engineer

Senior Supplier Quality Engineer - Exton, PA

Senior Treasury Analyst

Senior Manager, Carrier Strategy & Performance

Senior Accountant – Employee Benefit Plan Auditor

Senior Manager of Operations

Internal Audit Manager (must sit 1-2 days in Wayne, PA office)

Audit Analyst

Dir, Quality Assurance

Senior Auditor (US) - Compliance

Senior Underwriting Assistant

Senior Accountant

Regulatory Affairs Specialist

Associate Director, Regulatory

Risk Analyst

Senior Accountant

IT Audit Supervisor

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