Quality Assurance Manager
3 days ago
Touchlight is pioneering the Synthetic DNA market.
Touchlight is focussed on the enzymatic synthesis of novel DNA formats. Through the Covid pandemic, this quiet revolution has been propelled into the spotlight with the scale-up and proof of concept of RNA and DNA based vaccines. In addition, the stellar growth in viral and non-viral cell and gene therapy discovery and development has accelerated the need for a better quality, faster and more robust DNA manufacturing technology.
Our Contract Development Manufacturing Organisation (CDMO) and our technology is built on the conviction that DNA is fundamental to the future of medicine.
By moving away from today's restrictive biological approaches, we have made DNA manufacturing simple. Our unique dbDNA™ (or "doggybone" DNA) vector is optimised for use in advanced genetic medicines, being safer and more efficacious than conventional plasmid DNA. The platform, based on enzymatic technology, enables DNA production at unprecedented scale, speed and purity.
We are seeking a senior QA professional from a fast-paced, GMP background, ideally from Biotech or Pharma. You will bring strong leadership skills with proven change management experience, be highly commercial with the ability to engage quickly with internal and external stakeholders.
The Quality Assurance Manager is responsible for the Quality Assurance (QA) department
functions, reporting into and in support of the Head of QA to maintain the compliance with the
EU GMP Part II (ICH Q7) Quality Management System and demonstrating compliance through
Good Manufacturing Practice (GMP) principles.
This is an operational QA role. There will be close working with the Compliance, Validation,
CMC-Development, Production, Continuous Improvement and Commercial Teams to support
on-going project and product needs.
Key systems in Quality Assurance will include Quality Events and Deviations, CAPAs, Root Cause
Analysis, Risk Assessments, Self-inspections, Internal and External Auditing, Batch Review,
Validation and Qualification, Change Control, Training, Data Integrity, Document Control, Complaints and Continuous Improvement initiatives.
You have:
- An expert knowledge of GMP Quality Management Systems
- A minimum of 7 years’ experience working within QA of which at least 2 years within a QA Manager position.
- Requirement to have worked for a CDMO at all stages of product development.
- Knowledge of core QA systems, such as Quality Events, Deviations, CAPA and Change Management
- Knowledge of quality risk management, root cause analysis and FMEA processes
- Working knowledge of regulatory requirements related to GMP .
- Solid experience in participating in client and regulatory audits and supporting other business functions with applying appropriate CAPAs is desirable.
- Experienced in internal auditing.
- Experience using electronic Quality Management Systems.
We Offer:
- A fantastic opportunity to join Touchlight during an exciting growth phase
- An incredible culture, which celebrates creativity and diversity and attracts, nurtures, and rewards talented employees
- An attractive salary and benefits package
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