Head of Quality and Operations

Are you a Head of Quality and Operations looking for a new challenge?
Do you have experience of working in the Pharmaceutical/MedTech industry and love being hands-on? Have you got experience of developing and maintaining a robust QMS that aligns with ISO 9001?

If this sounds like you and you have that QA mindset, where you embed quality in everything you do, then this could be the perfect opportunity for you!
This small organisation is headquartered in Cambridge but have very much adopted the ‘remote first’ way of working (within the UK). They meet up once or twice a month to help information share and collaborate and have a lot of trust in their employees. We have placed a number of people into this organisation and they’ve been continuously growing ever since we’ve partnered with them a couple of years ago.
They’re a small, well-funded company, that support pharmaceutical and medtech companies with risk management solutions.

You will be part of the leadership team and will play a crucial role in ensuring the continued success of this business.

To be successful in this role, you’ll need proven experience in quality management, with a strong understanding of the ISO 9001 standard and GXP regulations as well as experience of managing an ISMS and the ISO 27001:2022 standard. You’ll also need to be up to date with the latest data protection laws and regulations and understand application of QMS in software development processes and validation to CFR21 part 11.
You’ll also be a confident leader, with excellent communication skills, with a Degree in a relevant subject.

You’ll take control of things like:

Developing and maintaining a robust QMS, aligning with ISO9001 and GXP regulations, as well as overseeing and maintaining the ISO27001:2022 ISMS and data projection obligations and certifications
Keep on top of EMA, FDA GXP requirements, with a focus on software development and validation to CFR21 part 11
You will also get stuck into things like planning, resourcing, performance monitoring, etc.
Regularly carry out quality reviews of things such as business processes to ensure they meet the quality standards. And manage, update and implement security measures to protect sensitive information.
Champion quality culture throughout the business and take a lead on all client and regulatory audits.
Maintaining their certified B-Corp status
Allocating resources effectively to support operational/project activities
Developing, updating and implementing operational plans to ensure efficient and effective delivery of their services
You’ll also get stuck into things like driving continuous improvement initiatives across all operational areas and monitoring project performance and helping to identify areas of improvement
You’ll work with the finance team to deliver management reports for the leadership team on all aspects of business performanceSounds interesting? Hit apply, or find me on LinkedIn (Aimee Vincent-Bunn) and we can have a chat