Do you have a strong foundation in Quality, gained in a Pharmaceutical or similar life science environment? Are you an experienced Lead Auditor, with IRCA certification and expertise in vendor management? Are you excited about travelling internationally, to countries including South Korea, USA and places around Europe? If so, this new position will be ideal for you.
This a permanent role for a Head of Corporate Audit Compliance, to join a leading vaccine organisation with a presence across a number of countries across Europe and elsewhere. You will lead and develop the Corporate Quality Audit function and team, ensuring effective management of corporate vendor and internal audits and regulatory inspections. You will be accountable for ensuring that risks and solutions are identified and implemented, and company-critical risks are escalated and resolved in a timely way. Your role will encompass all existing and new vendors into the business, and as such will cover the full spectrum of GxP compliance in some instances and further regulations in others.
This will be a varied, exciting role that will make full use of your auditing expertise and your ability to build and nurture strong relationships with 3rd parties. You will work in partnership with existing and potential vendors including Clinical Trial partners, API manufacturers, Packaging businesses, Excipient suppliers, Pharmacovigilance service companies, CTS companies and more. Your auditing activities will cover the whole spectrum of GxP operations, so this will be a fantastic way to make full use of your skills across GMP, GLP, GCP, GDP etc.
If you enjoy travelling and communicating with a variety of people across different organisations, this will be an amazing career opportunity!
This is a permanent role paying an excellent salary (to discuss on application, but within the range of £60k-£80k depending on experience), plus bonus, benefits and travel expenses. You will need to spend time regularly on site (near Brighton, on the South Coast) but your role will be hybrid with a mix of home-based, site-based and travelling abroad.
Reporting to the Corporate Governance Director, you will undertake a broad role that includes:
· Developing the scope of the Corporate Audit Team to incorporate global site auditing, identifying business risks across all sites
· Overseeing all risk-based external and internal audit schedules across GMP, GLP, GCP, GDP etc
· Leading the assignment of internal and external auditors
· Being QA Lead for the Vendor Management programme and ensuring the right training is delivered
· Conducting, reporting and following up Audits and Risk Assessments
· Reviewing and improving current processes, driving a process of continuous improvement
· Building strong relationships with key stakeholders
Full details will be provided on application.
A pioneering Europe-based Biopharmaceutical organisation specialising in the treatment and prevention of life-threatening allergies. The company employs around 300 people across on the South Coast and has an excellent reputation for providing career development opportunities, challenging and engaging work and a fast-paced, modern working environment. They have a strong presence in Germany, Italy and Spain, as well as emerging markets in other countries including USA, Australia, Albania, Macedonia and elsewhere.
The successful candidate will be an ambitious individual with substantial experience in a Lead Auditor role in a QA environment. You will ideally have IRCA Lead Auditor certification, with extensive skills in conducting audits and risk assessments with a variety of external vendors. Whilst experience across GxP would be advantageous, candidates will be considered if you have only worked within GMP/GLP, or only within GCP. The most important thing is that you have excellent relationship-building skills, together with strong awareness of current EU and UK legislation and regulatory guidance.
The company is based on the South Coast in West Sussex (near Brighton), so if you live nearby then this would be a bonus. However, you can work from home, provided you are flexible and can travel internationally.