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.
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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
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$86,500 - $144,000 a year
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.
