Job Description
Our client, a growing blue-chip multinational healthcare company based in Connaught, now seeks a suitably experienced Software Quality Assurance Manager who will provide effective leadership across global businesses, contributing to strategic programs and developing a high performing Software Quality team in a highly regulated environment.
This global role will lead project team members on multiple sites in development, implementation, and maintenance of IT, clinical, manufacturing, quality software. This permanent role represents an attractive opportunity for career progression within site and global teams.
The successful candidate will provide effective leadership and management of Software Quality leads; with responsibility for the development, deployment and maintenance of Software Quality and Validation policies, procedures, and methods in line with company SOPs and external regulatory requirements GXP.
Responsibilities for Software Quality Assurance Manager:
Develops and manages a high-performance Software Quality engineering team with focus on customer needs, compliance, product quality, and risk mitigation.
Demonstrate mastery of the software validation processes at company, e.g., including GSM, Spreadsheet Validation, etc.
SME and advocate for quality philosophies, principles, methods, tools, standards, and regulatory requirements.
Takes a leadership role in developing and implementing initiatives to enhance the Quality management system.
Develop staff on new quality initiatives and lead understanding and rollout of quality initiatives.
Champion continuous improvement with particular focus on Computer System Validation initiatives.
Responsible for the full definition and capability of a software system and for developing new methods and processes from strategy to execution while ensuring that the company’ software systems are defensible for regulatory requirements.
Requirements for Software Quality Assurance Manager:
Bachelors Degree in Science, Engineering or similar technical discipline. Advanced qualifications are desirable.
10+ years industry experience, 5+ years of which in Software Quality Assurance and Validation.
Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11, and SoX for Medical Devices
2+ years Team Lead / Management experience, in people management, people development, etc.
Must have good understanding of quality system requirements and how each quality system element connects.
Experience in working with ‘Agile’ software development and validation methodologies.
Proven stakeholder management experience, internally and externally.
Experience managing projects and project deliverables to completion.
Strong communication & influencing skills, and proven ability to present to leadership team.
Project management and troubleshooting skills.
Creative and innovative thinking skills.
Please phone Larry on +353 1-2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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