Senior GCP Quality & Compliance Auditor

Alimentiv; Philadelphia (Philadelphia County); Remote; USD 95,000 - 159,000; Full time

Job summary

A leading compliance research organization is seeking a Senior GCP Quality & Compliance Auditor. This remote position requires 7-9 years of experience in quality auditing within clinical research, alongside a strong knowledge of GxP guidelines and regulatory frameworks. Responsibilities include leading audits, developing strategic audit plans, and ensuring compliance with industry standards. The position offers a salary range of $95,500 - $159,000 per year plus bonuses.

Qualifications

• 7-9 years of experience in a quality auditing function.
• Certified Auditor (ASQ, ISO, or equivalent).
• Strong understanding of ICH GCP, ISO 19011, and related standards.

Responsibilities

• Lead and execute quality and compliance audits.
• Develop and implement risk-based audit plans.
• Conduct training for auditors and staff.
• Prepare reports on audit findings.

Skills

Regulatory compliance

Quality assurance

Auditing

Risk management

Data analysis

Communication

Education

Honor's Bachelor's degree

Job description

Senior GCP Quality & Compliance Auditor

As a technical expert in quality and compliance, the Senior Quality & Compliance Auditor plays a critical role in ensuring adherence to company policies, study protocols, GxP guidelines, and global regulatory requirements governing clinical research activities. This position requires a deep understanding of regulatory frameworks and risk-based auditing methodologies to drive compliance, enhance quality standards, and mitigate organizational risks.

Audit Planning, Execution, and Management Responsibilities

• Lead and execute comprehensive quality and compliance audits in accordance with regulations and standards governing clinical research (including internal audit, vendor audit and site audit) to assess adherence to regulatory standards and company policies
• Develop and implement strategic, risk-based audit plans to proactively identify areas of concern and ensure regulatory compliance
• Provide expert consultation on GxP requirements and quality assurance strategies, guiding both internal and external stakeholders
• Coordinate and conduct clinical sites audit in collaboration with project management teams, ensuring efficient and effective audit execution
• Lead audit facilitation efforts with external auditors and regulatory authorities, ensuring thorough preparation and representation of Alimentiv
• Analyze and interpret audit findings to author or direct the preparation of detailed audit reports, identifying risks, gaps, and areas for improvement
• Oversee and review corrective action / preventative action (CAPA) plans, ensuring timely implementation and effectiveness in addressing non-compliance issues
• Perform trend analysis on audit findings, providing data-driven insights to support continuous quality improvement initiatives
• Develop and lead Alimentiv's auditor training program for Corporate Quality, ISO auditors and other Alimentiv staff by providing guidance on audit techniques, risk assessment and system approach
• Organize and conduct mock inspections to prepare teams for external regulatory audits and identify potential compliance risks before formal inspections
• Review and approve audit reports prepared by junior auditors, ensuring accuracy, clarity, and regulatory alignment
• Stay abreast of evolving regulations and best practices related to clinical research activities to ensure the company's audit strategies remain current and effective.
• All employees are expected to complete training on time and maintain a minimum level of 90% training compliance at all times.

Qualifications

At minimum, qualified candidates will have :

Education : Honor's Bachelor (minimum)

Experience : 7-9 Years in Quality auditing function in a contract research organization (CRO), pharmaceutical, biotechnology, or related organization

Understanding compliance and risk management issues relating to clinical research, and strong understanding of research ethics and privacy

Previous experience leading a team is required

Certified Auditor (ASQ, ISO, or equivalent)

Expertise in regulations and standards governing clinical research including ICH GCP, ISO 19011, EMA Guideline on Computerized Systems and Data Integrity in Clinical Trials, etc.

Advanced technical knowledge in global regulations and industry standards as they apply to clinical research, medical devices and pharmaceuticals and in the conduct of clinical study operations

Knowledgeable of medical imaging and clinical research industry regulations and standards

Experience working and collaborating in a cross-functional global team environment

Excellent verbal and written communication skills required to draft and author written documents / reports / presentations

Strong interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback

Ability to plan, organize, prioritize and manage workload independently

Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge

Superior analytical skills focusing on identifying potential compliance issues, investigating root causes, brainstorming and identifying alternatives and assessing the effectiveness of actions

Proven skills in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues

95,500 - $159,000 a year + bonus

Work location and conditions : Home-based, Remote, regular office-hours

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