Manager (Audits & Inspections)

Employer
Hobson Prior
Location
England, Oxfordshire, Oxford
Salary
£60000 - £70000 per annum
Closing date
23 Sep 2020

View more

Discipline
Quality, Auditor
Hours
Full Time
Contract Type
Permanent
You need to sign in or create an account to save a job.

Hobson Prior are working with a world-wide biopharmaceutical company who are currently recruiting for a Manager (Audits & Inspections) to join them on a permanent basis in Oxford. As the Manager you will lead and participate in various types of GCP/GLP compliance audits for the organisation's development programs.

Job Responsibilities:

  • Conduct/support GCP/GLP compliance audits of clinical investigator sites, service providers and internal system/process audits in accordance with the annual audit plan to determine compliance status and identify compliance risks.
  • Co-operate with clinical compliance leads to identify audit needs and follow up post-audit activities to ensure appropriate implementation of CAPA and monitoring successful completion of action items.
  • Prepare audit reports and communicate audit findings to audit stakeholders as well as R&D Quality Management ensuring understanding of observations.
  • Assist in managing and training external auditors ensuring compliance with the organisation's auditing standards and procedures.
  • Provide pertinent data to support quality and compliance metrics and trending.
  • You will assist in the planning of clinical quality audit programs.
  • Develop and maintain study specific audit plans and audit certificates.
  • Participate in strategic planning of organizational activities, as required.
  • Support inspection management lead to maintain R&D inspection readiness at times.
  • Partake in regulatory agency inspection activities pertinent to R&D.

Key Skills:

  • Ability to manage multiple priorities simultaneously and work efficiently in a fast-paced culture.
  • Strong and clear understanding of Good Clinical Practices.
  • Strong knowledge of applicable global regulatory requirements.
  • Must be disciplined, detail orientated and excel in personal time management.

Requirements:

  • Bachelor's Degree in business or Life sciences is required, advance degree is preferred.
  • Industry certification in Quality Assurance is preferred but not required.
  • You will have a minimum of 5 years pharmaceutical or biotechnology industry experience in performing audits and participating in regulatory inspections.
  • GCP audit experience is required, GVP and GLP experience is valuable but is not essential.
  • Knowledge/understanding of the perspectives of regulatory agencies.
  • Domestic and international travel is required.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Contact Us
  • Wellington Gate
  • 7-9 Church Rd
  • TN1 1HT
  • GB
  • 01892 612 612
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert