Project Quality Manager

BRINE SA places the customer needs firmly in the centre and offers a speedy and professional solution. We carefully select suitable consultants and IT-specialists on the basis of their qualification. We pay particular attention to their education, business and technical knowledge, professional experience, individual character and not least, personal preferences

We are looking for an individual as PROJECT QUALITY MANAGER

ROLE PURPOSE, MAJOR ACCOUNTABILITIES:

- Maximize the business value of Strategic/Global Programs and Projects (Programs/Projects), ensuring effective alignment of IT compliance requirements with business requirements
- Develop an environment which fosters a high-performance and innovative organization
- Achieve the most efficient execution of Programs/Projects providing highest business value through effective management of IT compliance requirements
- Ensure for Programs/Projects that quality and compliance (Q&C) and information security management resources are available to accomplish program tasks on time, on budget and on quality
- Determine and apply the specifications of the applicable Quality Manuals, eg Corporate IGM Manual, GIS Risk and Compliance Manual, Vendor Manuals, to ensure Programs/Projects continuously meet their specified corporate and regulatory internal and external requirements
- Ensure the operation of the Programs/Projects is in accordance with corporate and regulatory standards including ICE, GxP, Sarbanes-Oxley Act of 2002 (SOX), IT InControl, Information Security (ISEC), IT Security, Data Protection (Data Privacy) and Business Continuity Management (BCM)
- Partner with compliance related key stakeholders and departments in order to align quality related objectives, processes and to achieve common agreement on standards and delivery
- Ensure that risk assessments/reports are produced for Programs/Projects Report quality and compliance project status and issues where help is needed to the Steering Committee
- Contribute to business decisions in the definition and assessment of IT requirements
- Initiate, lead and support Programs/Projects and their delivery in accordance with program goals, time scales and costs in compliance with Pharma methodologies
- Evaluate and recommend an effective and appropriate Programs/Projects quality approach amidst complex landscapes and scenarios
- Develop and maintain the Q&C work breakdown structure in collaboration with the Program/Project manager. Assist with the tracking of the delivery of Programs/Projects against the business and project targets, and realigning targets early
- Conduct, monitor, and support Project Quality Reviews and their results, (eg Project Health Checks and Interim Quality Reports), for Programs/Projects to evaluate if projects and deliverables fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement
- Support the development and delivery of training in Q responsible to ensure mandatory and any other identified Programs/Projects required training and records are produced and stored according to established procedures
- Prepare, review and/or approve Program/Project documentation to ensure consistency with quality standards and quality of deliverables and obtain acceptance
- Coordinate documentation, testing, and Programs/Projects quality management activities to ensure compliance with business and regulatory needs, at least in the following areas: ICE, GxP, SOX, IT InControl, ISEC, IT Security, Data Protection (Data Privacy) and BCM
- Assess Programs/Projects risks (risk assessments), analyze potential mitigation strategies to reduce exposure and deliver guidance and consultancy within Programs/Projects. Ensure any project risks resulting in potential operational risks are identified and reported according procedure

Education:

- Fluent in English - oral and written
- German desirable
- Several years of experience as an IT Quality Manager, preferably in a similar role
- Experience together with a good understanding of processes/strategies/organization in following areas:
- Pharmacompliance in general
- Quality and compliance in the Pharma Global Infrastructure Service (GIS) organization in specific
- Qualification of infrastructure as well as validation of applications/IT systems
- Qualification in GxP
- Knowledge in ISEC and SOX requirements
- Good documentation Practice (GdP)
- Experience with MS Office Tools and MS SharePoint
- Team work in a challenging IT environment
- Ability to work in an international as well as multicultural environment
- Good written and verbal communication skills
- Flexibility and experience in prioritizing tasks
- Ability to deal with variable workload

Duration:

- ASAP
- 6 months
- 100%

Work Location:

-  Basle

Do you possess the skills and experience to be successful in this role?
Are you interested in working autonomously?
Are you interested in a new challenge?

Then please send your CV and Certifications to: Mr. Sascha Harnack