QA Auditor III

Description

The company is hiring experienced GCP QA Auditors at Level III and above for a GCP Quality Assurance Auditor III or Manager role, to strengthen its clinical auditing work through regulatory compliance and quality standards.

The role is in an office setting, on a standard Monday to Friday schedule.

A competitive sign-on bonus may be considered for qualified candidates.

Candidates must be based in Spain, the UK or France and hold the legal right to work there. The role is remote from one of these countries.

Responsibilities

• Conduct or lead client, internal and GCP audits and regulatory inspections when senior management asks.
• Carry out directed audits of sites, facilities, vendors and sub-contractors.
• Advise project teams and external clients on GCP.
• Lead process audits, and join more complex system audits as a co-auditor.
• Run other QA audits and activities, such as database audits, clinical study report audits, sample results table reviews and process improvement work.
• Act as the go-to expert for operational departments on audit and quality assurance matters.
• Prepare and present audit findings and related information to departments, internal operations teams and clients.
• Travel across EMEA is required, roughly 12 to 15 trips a year, or 1 to 2 a month on average.
• Essential experience: GCP auditing and investigator site audits.

Requirements

• A bachelor's degree or equivalent, plus a relevant formal academic or vocational qualification.
• Previous QA experience that gives you the knowledge, skills and abilities the role needs, ideally 3+ years.
• In some cases, a mix of education, training and directly related experience may be accepted in place of a standard requirement.
• Thorough knowledge of GxP and the relevant regional research regulations and guidelines.
• A proven record of leading project-based or internal GxP audits and vendor audits to the standard management expects.
• Excellent spoken and written communication.
• Strong problem solving, risk assessment and impact analysis skills.
• Solid experience in root cause analysis.
• Above-average negotiation and conflict management skills.
• Ability to stay flexible, juggle several tasks at once and set priorities when demands compete.
• A valid driver's licence, and the ability to get and keep a corporate credit card with a credit line large enough for business travel.

Conditions

The work takes place in an office, laboratory or clinical setting.

You may be exposed to biological fluids and potentially infectious organisms, as well as electrical office equipment.

Personal protective equipment, such as eyewear, garments and gloves, is required.

You will need to stay upright or stationary for 6 to 8 hours a day.

Repetitive, quick hand and finger movements with both hands.

Frequent movement, occasional crouching and stooping, and frequent bending and twisting of the upper body and neck.

Lifting and carrying of light to moderate loads, including luggage and a laptop, up to 15 to 20 lbs.

Use of a range of in-house and off-the-shelf software.

Clear speaking and writing, and active listening to spoken information and ideas.

Frequent contact with varied groups to share or gather information.

Handling a wide, unpredictable mix of changing tasks, under stress, while multi-tasking.

Regular, consistent attendance is expected.

The company is an equal opportunity employer.

Benefits

• Join a global team that values collaboration and growth, where your contributions make a visible difference.