We are seeking a highly skilled and motivated Audit Lead with a passion for the Pharmaceutical & Biologics Industry. As a key member of our team, you will be responsible for ensuring compliance with quality assurance standards for all audits, as well as leveraging your communication skills to help build our brand & culture. Apotech’s Audit portfolio is already robust and so we are looking for someone to set up an internal team to move our capability to the next stage!
Role and Responsibilities
- Plan, execute, and manage audits for Biotech, Pharmaceutical, and Medical Device clients, ensuring compliance with applicable regulatory requirements, guidelines, and industry best practices.
- Develop comprehensive audit plans, including scope, objectives, timelines, and resource requirements.
- Manage and implement yearly annual audit plans with the clients
- Conduct on-site and remote audits of clinical trial sites, contract research organizations (CROs), and other relevant stakeholders.
- Support the sales team in preparing tailor-made commercial proposals.
- Collaborate with cross-functional teams, including Clinical Operations, Quality Assurance, Regulatory Affairs, and Project Management, to ensure timely resolution of audit findings.
- Identify deficiencies and areas for improvement and provide recommendations for corrective and preventive actions (CAPAs).
- Contribute to the development and improvement of audit processes, tools, and templates
- Take part in the wider company marketing plan, by preparing professional articles and posts to share your audit knowledge
Required skills and qualifications
- Several years of experience in GCP auditing within the life sciences industry, preferably in a consultancy or CRO environment.
- Strong attention to detail and ability to work independently, while also collaborating with cross-functional teams.
- Excellent verbal and written communication skills, with the ability to effectively communicate complex information to diverse audiences.
- Proficiency in using audit management tools and software.
- Experiences in other GxP areas would be a plus.
- A second language would be an asset.
WHY JOIN US?
- Offices in London, and Paris & future offices in Switzerland & the USA with the opportunity for international development
- Yearly companywide holiday & also workshops with the opportunity to work from the Paris office
- 4-day working week : trial on going up to July 2023
- A flexible working environment in which we work hybrid from the trendy London Borough office (less than a 10-minute walk from London Bridge) and remote-based in which we will support with setting you up your home office
- A fast-growing start-up in the early stages of growth that gives you endless opportunities to grow rapidly with the business
- Endless opportunity for career development, no red tape or barriers for people who work hard to get where they want to be
- The people! A family feel working environment in which everyone wants to work hard, as well as be supportive and have fun
- Generous Wellness & Fitness Allowance as well as a free office gym that can be used