QA Manager (Biotechnology)

Full Job Description

About Us:

Join the multiomic revolution! Over the last 20 years, genomic technologies have enabled significant discoveries that bring the promise of personalized medicine closer than ever before. But after two decades of research, it’s clear that genetic variation only tells part of the story – biology is dynamic and more complex than A,C,T,G. Already, the added information from a multiomic view of biology is yielding important insights into cancer, aging, and neurological disease, and is poised to revolutionize how we understand health and disease beyond canonical variation in DNA.

biomodal is an omics-based life sciences technology and analytics company delivering products that bring the dynamism of our ever-changing biology into focus. Our team is dedicated to developing the most advanced solutions to interrogate and understand the complex interplay of genomics and epigenomics.

We have just launched our first product, the duet multiomics solution +modC solution and are looking to grow and evolve our business accordingly.  This is an incredible opportunity to step into an exciting, early-stage company at the cutting edge of science with exceptional growth and market impact potential. Multiomics is the future – come join the biomodal team!

The Team:

The Operations function is a multi-disciplinary team whose remit is to support biomodal’s ability to scale and drive the efficient production and distribution of its products.  Encompassing Manufacturing, Quality, Logistics and Project Management, the team is a critical part of biomodal’s evolution from a start-up technology company to fully a fledged SME.

The Role:

As part of drive to launch a transformative range of products, based on our novel DNA sequencing technology, biomodal is expanding its Operations function with the appointment of a Quality Assurance Manager.  This is a new role to the business, with an exciting chance for the incumbent to own and continuously improve the eQMS.  Reporting to the Global Head of Operations, this role will focus on ensuring biomodal’s activities meet ISO9001 standards, both internally and with its external manufacturing partners.  Given the nature of its technology, and the potential opportunities in the diagnostics space, a drive towards the ISO13485 standard would also be potentially on the horizon.

This then represents an exciting opportunity to support biomodal in developing a value-add QMS that brings credibility and robustness to our commercial offerings.

Key outputs of this role:

·         Ensure the organization stays compliant with the selected standard.

·         Implementation and maintenance of the QMS.

·         Perform internal Audits and Management reviews.

·         Communication with external parties, such as certification bodies, customers, and regulators.

·         Training and maintaining awareness of the QMS throughout the organization.

The Person:

The ideal candidate for this role will be an experienced Quality professional, who has hands on experience with QMS in the biotechnology, pharmaceutical or diagnostics sector.  They should be comfortable having ownership of a QMS and implementing it across a business to ensure that all parties understand the value that comes with it.  The individual should also have experience working with external suppliers and manufacturing partners and be committed to building strong relationships across biomodal’s supply and logistics chain.

Due to the size of the organisation, this role will still have hands-on QA operational elements, such as document management, internal/external auditing, CAPA and change management projects; but they would be supported in this by the wider Operations function and from key stakeholders in other departments.

Key attributes would be:

·         Very good understanding of Quality principles and standards

·         Knowledge of relevant industry regulations and standards (e.g., ISO, 21 CFR 820, cGMP) and the ability to ensure compliance..

·         Audit and Inspection experience

· Strong verbal and written communication skills

·         Analytical and Problem solving skills

·         Customer focus

This is an exciting and rare opportunity to get involved with a biotechnology business at the ground level and be a driving force in its evolution into a fully-fledged commercial SME.

• Annual bonus scheme
• 10% pension
• 25 days annual leave
• Private medical and life Insurance
• Hybrid working
• Great in-office benefits