Contract, Auditor
Primary stack
Nice to have's
Job description
About the Position
We are currently searching for a skilled professional to join a well-known client’s team as a remote Contract, Auditor. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
Responsibilities
- Execute the annual GCP/GVP audit plan by leading vendor audits and reviewing questionnaires.
- Manage audit issue resolution and maintain the audit observation database, delivering metrics and trend analyses to leadership.
- Oversee GxP vendor lifecycle management, including risk assessments, initial qualification, requalification, and maintenance of the Approved Vendor List.
- Serve as a key QA point of contact for vendor-related audits, performance oversight, and compliance decision-making.
- Provide support during GxP health authority inspections.
- Support development and maintenance of GxP quality documentation, including SOPs, policies, templates, and work instructions.
- Oversee maintenance of clinical site and vendor quality documentation archives.
Requirements
- Minimum five years of experience in GCP/GVP, including both external and internal auditing. GLP/GCLP vendor management experience is a plus.
- Extensive experience with global clinical trial conduct; knowledge and understanding of ICH E6 GCP Guideline, FDA regulations, and EU requirements.
- Previous experience facilitating and/or supporting Regulatory Authority inspections.
- Previous experience in development and oversight of Quality Management Systems.
- Excellent interpersonal skills, personal integrity, professional manner, and the ability to gain respect and develop strong working relationships with cross-functional personnel at all levels.
Education
- Bachelor’s degree in Life Sciences with 10 years in pharmaceutical or biotech drug development. (Advanced degree preferred)
We Offer
- Competitive salary
- Remote work options
- Health coverage, life insurance, disability insurance, and 401k benefits
About the Company
At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Clinical is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Clinical complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].
© Advanced Clinical. This job description was sourced from the employer's public career page. TheJob is not the employer — we index the posting and route candidates to the source. All content rights and hiring decisions belong to the employer.
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences.