FDA Pharmacovigilance Auditor

Job Description

Are you passionate about quality in the life sciences area? Do you want to work with the most prestigious names in pharma, bio, animal health and similar regulated environments? If you have an eye for detail and want to help assure quality of life, then this is the role for you!

What to expect:

You will be part of a global quality auditing team responsible for assuring quality in the supply chains of our clients in the pharmaceutical, medical device, cosmetics, biologics, and/or animal health industries. Covering your local region, you will work closely with SQA’s operations center to coordinate, prepare, execute, and deliver supplier quality audits based on client audit schedules. You will work with SQA’s world-class production team to align your expert findings to the individual structure and guidelines of each client’s managed audit program.

What you’ll do:

You will be performing quality audits at suppliers to SQA’s clients. Each client has unique program needs to which you will be oriented as part of your on-boarding for each program. You will apply your skills and experience within the parameters of each program to produce the consistent results needed for seamless integration of audit results into each client’s supplier risk management framework.

What you’ll need:

You will need to have expertise in US FDA Pharmacovigilance regulations. You will need experience managing PV agreements with multiple parties and assertiveness dealing with difficult auditees.

As an SQA Quality Auditor, you will have at least four years experience and will be deployed based upon your subject matter expertise relative to the manufacturing environment. You will possess expert knowledge relating to specific commodities and tools. You'll be considered for other audit projects depending on your skill set (e.g., 21CFR 210/211, 21 CFR 820, ICH guidelines, 21 CFR 58, 21 CFR 11).

Strong English speaking, reading and writing skills are necessary and willingness to travel regionally is desired.

Pay Range: 

$1100-1200 USD for a 1 day audit. Includes: Time spent preparing for the audit, traveling, performing the audit, writing the report, and responding to questions from our Content team of editors and the client until the report is finalized. Does not include: Following up on CAPA for any findings or reimbursement for travel expenses - expenses are reimbursed at cost with receipts per SQA travel policy. Note that SQA helps with the preparation of the audit and proofreads all audit reports.