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 high-risk non-compliance 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 Job-Related Skills:

• High degree of organizational awareness and in-depth 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 setting 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.

📌 407643 Computerised Systems (CS) Senior Manager/Manager (Indiranagar)
🏢 ScaleneWorks
📍 Indiranagar