Associate Director, Audit Management - REMOTE job in Dallas, USA

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First Name*

Last Name*

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Job type: Permanent

Discipline: Analyst, Auditing, Finance

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a remote Associate Director, Audit Management for an innovative biotech company.

Must be eligible to work in the US.

Job Responsibilities:

Ensuring audit objectives and scope are risk based in alignment with the audit strategy
Coordinate and oversee audits performed by contracted auditors. This involves scheduling audits, selecting resources, reviewing reports, etc.
Ensure audit documentation is completed according to procedures and established timelines
Act as a liaison to internal stakeholders through all phases of the audit
Ensure that newly identified risks are considered for the audit strategy
Support development of a robust CAPA (Corrective and Preventative Action) Plan and approve the CAPA plan
Track CAPA and effectiveness checks to completion
Manage direct reports and/or relationships with audit vendors
Responsibility for audits within a particular therapeutic area, type (i.e. vendor or clinical site), and/or expertise (i.e. GxP area, digital, etc.)
Monitor and analyze trends in audit observations
Execution of the audit (remote or on site) when the audit is not contracted
Coordinate/manage/support health authority inspections
Lead audit management continuous improvement efforts
Travel up to 10%

Skills and Requirements:

Academic degree/ Life Sciences degree preferred, Master degree desired
Excellent English skills (written and verbal) to interact with auditees and stakeholders
Comprehensive knowledge of ICH GCP and GVP guidelines and other international GxP regulations as appropriate
Critical thinking skills and understanding of Quality by Design (QbD)
Proven interpersonal skills including good negotiating skills
Very good understanding of Clinical Development activities and the applicable regulations
Expertise in one or more technical aspects, for example: investigator site audits, vendor audits, PV audits, lab audits, IT audits, etc.
Experience managing people and/or projects
Comprehensive audit skills within a GxP discipline
6 years experience in clinical/PV auditing and/or years of work experience in a clinical research and/or related QA environment preferred

If you are having difficulty in applying or if you have any questions, please contact Christina Chung at +(1) 857-233-9215 or c.chung@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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