407643 Computerised Systems CS Senior ManagerManager
407643 Computerised Systems CS Senior ManagerManager
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Job Description
Key Responsibilities:
Develop and incorporate effective processes and procedures and may contribute to business processes and procedures.
Assure computer systems meet regulatory requirements and that they conform to regulatory expectations.
May interact with regulators.
Support/Manage routine computer compliance assessments (internal & external)
as well as computer compliance initiatives of demanding high priority including regulatory inspections and highrisk noncompliance issues.
May lead initiatives program or team activities as required.
May be responsible for coaching mentoring training others.
Identify computer related business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
Contribute to or lead the training education guidance and influencing of Client R&D staff on best quality and computer compliance policy and practices.
Assure compliance with computer compliance regulations and expectations and Client related policies and procedures.
Provide computer compliance advice and consultancy to Client project teams and external partners to reduce regulatory risk to Client.
Represent CSQA as a primary business contact.
Identify and mitigate computer compliance risks to Client through effective assessments and/or via providing advice and consultancy to QA and business units regionally and globally.
Liaise with customers to provide computer compliance advice/input.
Proactively identify communicate and monitor business and/or regulatory changes that could impact on quality or compliance within and across departments.
Establish improvement processes as needed or set specific measurable targets and goals linked to Client business needs.
Any other duties relevant to and consistent with the level of responsibility of the job as required by management.
Education Requirements:
Bachelor s degree in a relevant scientific or engineering discipline or equivalent combination of education training and experience. Advanced degree preferred.
Job Related Experience:
Demonstrable knowledge of the regulated pharmaceutical industry and computer compliance regulations and expectations.
Communications are clear concise well structured authentic and easily understood.
Communicates and interacts at most levels both inside and outside of Client.
May influence and negotiate at most levels and may interact with regulators.
Build and maintain effective internal Client business relationships.
Other JobRelated Skills:
High degree of organizational awareness and indepth knowledge of the regulated pharmaceutical industry and computer compliance regulations and expectations
Good understanding of medical/corporate governance principles and demonstrated ability to develop sound solutions for complex problems.
Communicate with clarity impact and passion tailored to the audience.
Ability to make complex ideas simple.
Create an environment where open transparent communication especially providing and receiving feedback is valued and trusted.
Create an environment of empowerment and remove barriers to empowered action.
Effectively utilize internal and external networks to influence key stakeholders.
Ability to understand and integrate diverse opinions and perspectives in setting and delivering business objectives.
Remote Work :
No
Employment Type
Full Time
