Vacancy Detail

Technical Quality and Compliance Manager


Region: South Central

Location: Abingdon

Salary: £50000 - £60000

Ref: 04505

Job Type: Permanent

Posted: 29/10/2020

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Technical Quality and Compliance Manager


Role description

Role: Technical Quality and Compliance Manager
Therapy Area: Diagnostics - Infectious Disease & Cardiometabolic
Package: Competitive package based on experience, pension, private health, and additional benefits
Location: Abingdon

This is a great opportunity to join an established world leading healthcare company as a Technical Quality and Compliance Manager.

Role Type: Technical Quality and Compliance Manager

The client is a world leader in rapid diagnostics at the point of care, with a focus on cardio metabolic disease, infectious disease and toxicology. For more than 125 years, they have brought new products and technologies to the world - in nutrition, diagnostics, medical devices and branded generic pharmaceuticals. Employing more than 99,000 people worldwide to help people live not just longer, but better, in the more than 150 countries.

The Technical Quality & Compliance Manager is the go-to subject matter expert for all quality and compliance controls for the IT department around software and hardware development, support and maintenance. In this role you will report to the Director of IT and you will be responsible for identifying, leading, and/or supporting quality, regulatory, and compliance improvement initiatives, projects, and remediation activities at site, cross-site, and Business Unit levels. This position will focus on implementing and maintaining an effective document control process for the Business Unit and deploying Quality System programs to the Toxicology Business Unit.

This position is responsible for ensuring that the IT department practices, policies and processes are performed in accordance with quality, compliance, contractual, security and regulatory requirements. This position will leverage program management experience to drive key compliance initiatives, support and advise teams across the IT department on risk, and work in cross-functional partnership to help ensure those requirements are met. This position can interface with Quality functions, other Business Units, independent 3rd party auditors, partners, vendors, and customers in association with the quality and compliance area. Responsibilities:
This role supports the development, implementation, improvement, and/or effectiveness of the IT Technical Quality and Compliance Systems in compliance with applicable ISO, FDA, and other regulatory agency regulations and standards through implementation of effective Technical Quality System programs
Identify and document validation requirements for commercial IT systems and laboratory software systems (including instrument application software) and interfaces
Development of a master validation plan for commercial IT systems and laboratory software systems and interfaces
Conduct risk analysis, design mitigation plans, and implement necessary controls
Acts as a Subject Matter Expert in Technical Quality System areas such as Document Control, Management Review, Quality Metrics, and Inspection Readiness, while sharing knowledge through best practices and risk mitigation strategies
Works directly with entities in establishing compliant Technical Quality System processes and programs
Leads or assists internal and external audits as assigned
Execution of validation protocols generating reports including validation reports and risk assessments as required
Review and document laboratory requirements, define and implement procedures for instrument and data management / data integrity
Interact with equipment vendors and IT partners to support the development and implementation of data integrity controls
Able to support multiple business priorities and deadlines
Collaborate effectively with individuals and teams within the IT department
Mentor colleagues and team members on technical quality and compliance best practices and controls
Conducts periodic formal training in technical quality and compliance topics for the IT department
Assists in building a technical quality and compliance awareness program for the company
Maintain knowledge in the technical quality and compliance areas
Minimal travel between sites may be required for this position


Qualifications

Bachelors degree in Computer Science, Computer Engineering, Engineering related degree, and/or equivalent work experience Current driving license preferred

Person experience required

Significant practical experience of software development life cycle activities Thorough knowledge and practical application of Quality System Regulations regarding commercial and lab software and IT hardware Knowledge of computerised software validation requirements and procedures for laboratory instrumentation e.g. LC-MS, Immunoassay platforms, software, hardware and instrument qualification Experience of development and implementation of a software validation structure Significant experience in Quality Assurance testing or related industry with exposure to quality practices and quality processes Has an in-depth understanding of quality management systems, testing best practices and data integrity Experience with running a technical quality and compliance program and identifying risk Experience with leading audits by external parties Ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds Prior experience with FDA or related audits Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and best practices and give oral presentations Technical knowledge of enterprise software development is preferred Demonstrated ability to set and meet tight deadlines and function well under pressure Competencies: Ability to work independently or as part of a multidisciplinary team Demonstrate logical thinking and an ability to manage multiple activities / priorities Strong verbal and written communication skills with the ability to influence others Must show strong self-initiative and be comfortable in the role of a team player Must be able to work independently with minimal supervision Ability to work in a dynamic and fast paced environment Strong problem-solving skills Effective organizational and time management skills
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