Qa manager - united kingdom, cambridge, cambridgeshire

the role

are you a qa manager, who loves building innovative systems, looking for a move into technology? we've got a great risk based quality management implementation consultant (data manager) role. this is a remote position but our client's offices are in cambridge.

we are looking for a dynamic and motivated qa manager who will report directly to the ceo and work closely in partnership with the operations, finance and technology functions. we need someone with the experience to run the qa function without handholding, but who is also able to work

collaboratively with functional leads as and when needed.

the three main pillars of the role are as follows:

1. ongoing management and improvement of existing qms

2. supporting readiness for iso 27001 and latterly the ongoing maintenance and periodic re-certification

3. managing internal and external audits

the qa manager will ideally have experience of working for a clinical technology led business and understand the demands on qa from a gcp and isms perspective.

characteristics

minimum of five years of relevant experience

self-motivated and willing to take ownership and accountability

able to work alone but to collaborate and communicate effectively with peers from the leadership and management teams as needed

good understanding of gcp and information security management in a software as a service (saas) environment

the key functions performed by the qa manager will include, but may not be limited to the following areas:

management and oversight of the quality management system and associated documents

plan and deliver internal audit schedule

support through completion of the iso 27001 certification program and ongoing maintenance and re-certification

agree with senior leadership team (slt) and report on quality metrics for the organization

coordinate and contribute to client audits

coordinate and contribute to regulatory inspections

specify quality and regulatory requirements relating to suppliers

coordinate vendor qualification and oversight

advise and consult the slt, product development and operations personnel on regulatory requirements

be aware of, and share information regarding, evolving regulatory requirements

formally review business processes and outsourced functions with regard to regulatory compliance

determine, recommend and review in-house quality procedures, standards and specifications

management and oversight of corrective and preventative action (capa) process act as a regulatory advisor on computer system validation and compliance (csv&c) and gcpspecifically, and applicable regulations generally

act as qa reviewer on tri product validation and change controls

assess customer quality requirements and ensure that they are met

ensure that company processes comply with standards at both national and international level

work with operational staff to establish processes, procedures, systems and standards

direct objectives to optimise product and service quality

work with management to determine functional training needs

More jobs