Offer summary

Qualifications:

Honor's Bachelor degree or higher required., 7-9 years of experience in quality auditing within a CRO, pharmaceutical, or biotechnology setting., Strong understanding of compliance, risk management, and research ethics., Certified Auditor (ASQ, ISO, or equivalent) preferred. .

Key responsabilities:

Lead and execute quality and compliance audits to ensure adherence to regulatory standards.

Develop and implement risk-based audit plans to identify compliance issues.

Coordinate clinical site audits and facilitate external audits with regulatory authorities.

Analyze audit findings and oversee corrective action plans to address non-compliance.

Job description

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:

Requirements:

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

Strongly Preferred:

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

Interpersonal Skills:

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

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

PHISHING SCAM WARNING: Alimentiv is aware of the continued increase of phishing scams, leveraging various methods of attack via email, text, voice and social media. Please note that Alimentiv only uses company email addresses, which contain “@alimentiv.com”, to communicate with candidates via email. If you are contacted by someone about an open job at Alimentiv, please verify the domain of the sender’s email address and that they are asking you to apply on this website. If you believe you’ve been a victim of a phishing scam, please contact your local government cyber authority to report.

Required profile