PAREXEL Informatics is one of the industry's leading solution providers and we help customers accelerate the drug development process through innovation. Our product portfolio is built on leading-edge technology and is combined with extensive medical and clinical expertise. As the technology business unit of PAREXEL International Corporation, we're able to leverage our massive investment in technology with our parent company's wealth of hands-on clinical expertise.

This role is available due to an internal promotion, so if you are looking for an organisation that invests in you, values your time and expertise then please apply.
It is based in our new modern state of the art office in Nottingham city centre which has excellent transport links and has a great working environment and the feel of an innovative technology company.

Essential Function

The Senior Manager of Software Validation is a member of the RTSM Production leadership team. The Senior Manager is responsible for ensuring the provision of validation support for any new or ongoing studies as well as owning the departmental processes and managing process change within the RTSM function. This would also include development and/or implementation of tools and applications to support the RTSM function. The role is accountable for the creation of consistent validation documentation and the maintenance of a scalable approach to computerized systems validation. This role may be called upon to represent the department in audits.

The Senior Manager reports to the Director of RTSM Production and directly supervises managers and validation engineers within the department.
The manager will work closely with other managers within production as well as with Client Services Managers, Production staff (all levels), and Quality Management and RTSM Development.

This role is mostly line management and giving direction, with little technical responsibilities.

Key Accountabilities:

• Manages software validation daily strategies to ensure quality of software developed and release and ensure its conformance with regulatory requirements related to validation of computerized systems.
• Provides guidance and direction for validation department strategies.
• Manages development and maintenance of test cases, scenarios and test data including traceability to requirements for projects under validation and verification.
• Supports client and regulatory agencies audits as required.
• Writes, reviews and delivers the formal performance review to their staff.
• Undertake the full range of duties relevant to the leadership, management and development of the team to ensure their performance meets and or exceeds both the business and their own personal goals/objectives
• Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
• Participate in formal staff review processes e.g. performance and salary reviews to corporate standards and timescales.
• Deputize for Director of RTSM Production
• Participate in resource forecasting.

Qualifications

Skills:

• Excellent knowledge of software validation and verification techniques and test case development.
• Possesses a solid grasp of the management skills necessary for the management/project leadership of software validation engineers.
• Possesses the ability to comfortably manage multiple concurrent projects.
• Knowledge of the development of test case design and strategy.
• Knowledge of the development of standard operation procedures and validation documentation templates.
• Excellent interpersonal, verbal and written communication skills
• Client focused approach to work
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Willingness to work in a matrix environment and to value the importance of teamwork.

Education:
Degree in appropriate discipline or equivalent work experience

Minimum Work Experience:

• Experience in structured software development life cycle and validation, (preferably including software validation in a regulated industry).
• Experience Managing Validation teams.

In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary + bonus and benefits package including 25 days holiday per year, pension scheme, life assurance, long term disability insurance, a health cash plan and other leading edge benefits that you would expect with a company of this type.

Apply today to begin your journey!