Top 103 Senior quality auditor Jobs in Philadelphia, Pa

Associate Director, GxP Quality Auditor
Cabaletta Bio —Philadelphia, PA
- 5 years
- Bachelor's degree
- Budgeting
- Health insurance
- Paid time off
8d
Audit Senior 4 years plus experience
SD Associates PC —Elkins Park, PA
- $95,500 - $135,000 a year
- Full-time
- Hybrid work
- CPA
- Mid-level
- Office
- Disability insurance
- Health insurance
Quick Apply
Senior Supplier Quality Engineer
Victaulic —Pennsylvania
- Full-time
- Up to 50% travel
- 5 years
- Engineering
Senior TMF Lead
CSL —King of Prussia, PA
- Full-time
- Hybrid work
- Microsoft Word
- 6 years
- Writing skills
Audit Manager II (US) Internal Audit Learning and Development
TD Bank —Mount Laurel, NJ
- $94,980 - $153,790 a year
- Full-time
- 7 years
- CPA
- Writing skills
- Health insurance
- Paid time off
Senior Audit Manager
Everforth, Cybercoders —Philadelphia, PA
- $150,000 - $200,000 a year
- Full-time
- Hybrid work
- Management
- CPA
- Finance
- Profit sharing
- Health insurance
Quick Apply
Director of Residential Services
The Jewish Federation of Southern New Jersey —Cherry Hill, NJ
- $90,000 - $110,000 a year
- Full-time
- Experience working with individuals with developmental disabilities
- Microsoft Excel
- Microsoft Outlook
- Health savings account
- Health insurance
Quick Apply
Senior Auditor
Everforth, Cybercoders —West Chester, PA
- $85,000 - $110,000 a year
- Full-time
- Hybrid work
- CPA
- Mid-level
- Office
- Profit sharing
- Health insurance
Quick Apply
11d
Audit Manager II - Internal Controls over Financial Reporting-2
TD Bank —Mount Laurel, NJ
- $94,980 - $153,790 a year
- Full-time
- Oracle
- CPA
- 5 years
- Health insurance
- Paid time off
14d
Senior Audit Group Manager – Technology Audit
TD Bank —Mount Laurel, NJ
- $123,880 - $201,290 a year
- Full-time
- Basic math
- Office
- Bachelor's degree
- Health insurance
- Paid time off
Quality Engineer
Oliver Healthcare Packaging —Doylestown, PA
- Weekends as needed
- 6 years
- Engineering
- Microsoft Office
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
Senior Auditor (Hybrid)
Bancorp Bank, The —Wilmington, DE
- Full-time
- Hybrid work
- Background check
- Microsoft Excel
- Microsoft Outlook
HSE Senior Manager
Mission Critical Group —Harleysville, PA
- $120,000 - $160,000 a year
- Full-time
- 5 years
- Senior level
- Leadership
Quick Apply
Senior Auditor (Hybrid)
The Bancorp, Inc. —Wilmington, DE
- Full-time
- Hybrid work
- Background check
- Microsoft Excel
- Microsoft Outlook
Senior Quality Management Systems Specialist (US Citizen) – Camden, NJ – 5037
Altimeter Solutions —Camden, NJ
- Writing skills
- 3 years
- Analysis skills
Specialist, Risk and Compliance Services (Center of Excellence)
Deloitte —Philadelphia, PA
- $63,000 - $116,000 a year
- Full-time
- Microsoft Outlook
- Research
- Mid-level
Regulatory Filing Compliance Analyst
Penn Lumbermens Mut Ins Co —Philadelphia, PA
- Microsoft Word
- Writing skills
- Mid-level
Director of Residential Services
Jewish Federation of Southern New Jersey —Cherry Hill, NJ
- $90,000 - $110,000 a year
- Full-time
- Experience working with individuals with developmental disabilities
- Microsoft Excel
- Microsoft Outlook
Quick Apply
Senior Manager, Corporate Compliance - Market Conduct Exam
CVS Health —Blue Bell, PA
- $82,940 - $182,549 a year
- Full-time
- 7 years
- Office
- Bachelor's degree
- Health insurance
- Dental insurance
9d

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Associate Director, GxP Quality Auditor

Cabaletta Bio
Philadelphia, PA

Apply Now

Job Details

8 days ago

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 philadelphia, pa

Associate Director, GxP Quality Auditor

Audit Senior 4 years plus experience

Senior Supplier Quality Engineer

Senior TMF Lead

Audit Manager II (US) Internal Audit Learning and Development

Senior Audit Manager

Director of Residential Services

Senior Auditor

Audit Manager II - Internal Controls over Financial Reporting-2

Senior Audit Group Manager – Technology Audit

Quality Engineer

Senior Auditor

Senior Auditor (Hybrid)

HSE Senior Manager

Senior Auditor (Hybrid)

Senior Quality Management Systems Specialist (US Citizen) – Camden, NJ – 5037

Specialist, Risk and Compliance Services (Center of Excellence)

Regulatory Filing Compliance Analyst

Director of Residential Services

Senior Manager, Corporate Compliance - Market Conduct Exam

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