Risk & Compliance Manager
24 hours ago
By clicking the Apply button I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda s and I further attest that all information I submit in my employment application is true to the best of my knowledge The Future Begins Here At Takeda we are leading digital evolution and global transformation By building innovative solutions and future-ready capabilities we are meeting the need of patients our people and the planet Bengaluru the city which is India s epicentre of Innovation has been selected to be home to Takeda s recently launched Innovation Capability Center We invite you to join our digital transformation journey In this role you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement At Takeda s ICC we Unite in Diversity Takeda is committed to creating an inclusive and collaborative workplace where individuals are recognized for their backgrounds and abilities they bring to our company We are continuously improving our collaborators journey in Takeda and we welcome applications from all qualified candidates Here you will feel welcomed respected and valued as an important contributor to our diverse team The Role Our validation specialists are located at three sites in Bangalore Mexico City and Bratislava The teams are organized in what we call Towers ERP R D Infrastructure etc This role is intended to support the ERP Tower As Risk Compliance Manager you will lead validation activities within the ERP Tower ensuring compliance with regulatory standards and internal quality requirements This role involves managing a team of 10 validation specialists and collaborating across IT QA and business units to deliver robust compliant solutions Key Responsibilities Lead and manage a team of 10 validation specialists within the ERP Tower Oversee validation and qualification of IT systems and infrastructure to ensure compliance with regulatory standards and internal quality requirements Define validation strategies and objectives aligned with business and compliance goals Develop and maintain validation plans protocols and schedules communicate expectations clearly to stakeholders Identify and mitigate risks in validation processes implementing proactive strategies for successful outcomes Coordinate cross-functional teams QA IT engineering business units for timely execution of deliverables Monitor progress and performance providing regular updates and facilitating review meetings Ensure complete and accurate documentation per GxP and industry standards Drive adherence to regulatory guidelines FDA EMA and internal SOPs throughout the lifecycle Promote continuous improvement by evaluating processes and introducing efficiency enhancements Manage resource planning and prioritization in close collaboration with business stakeholders Additional Responsibilities Act as the primary point of contact for ERP validation demands ensuring timely assessment and execution of validation activities for new implementations upgrades and change requests Plan and manage validation projects end-to-end including scope definition timelines resource allocation and stakeholder communication Ensure risk-based validation approach for ERP systems balancing compliance requirements with operational efficiency Collaborate with business process owners and IT teams to align validation deliverables with system functionality and business needs Maintain validation readiness for audits and inspections ensuring documentation and processes meet regulatory expectations Drive standardization of validation practices across ERP systems and related infrastructure globally Support continuous improvement initiatives by introducing automation or digital tools for validation documentation and reporting Provide training and guidance to team members and stakeholders on ERP validation principles and compliance requirements Monitor industry trends and regulatory updates to keep validation strategies current and compliant Qualifications Min 10 years of experience in a similar role Proven ability to develop and execute validation strategies for SAP 4 Hana implementations and rollouts including system upgrades and migrations Experience from leading or coordination cross functional teams e g IT QA Business process owners project managers and vendors Strong experience in SAP ERP modules e g Finance Supply Chain Manufacturing and their integration points Hands-on knowledge of SAP GxP compliance requirements including validation of SAP cloud solutions and related infrastructure Bachelors or Master s degree in a relevant scientific or engineering discipline e g Computer Science Engineering Chemistry Pharmacy or related fields Experience with PMP or Agile or other iterative project management methodologies is a plus Proven experience as an IT Project Manager with a track record of successfully delivering IT projects on time and within budget Strong understanding of project management methodologies and best practices Excellent leadership communication and interpersonal skills Exceptional problem-solving and decision-making abilities Proficiency in project management tools and software Ability to work collaboratively in a cross-functional team environment Strong organizational skills and attention to detail Excellent people management skills with experience working in global multi-cultural organizations Ability to balance compliance efficiency and business needs a risk-based approach Good technical understanding of SAP cloud solutions Benefits It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career Amongst our benefits are Competitive Salary Performance Annual Bonus Flexible work environment including hybrid working Comprehensive Healthcare Insurance Plans for self spouse and children Group Term Life Insurance and Group Accident Insurance programs Employee Assistance Program Broad Variety of learning platforms Diversity Equity and Inclusion Programs Reimbursements - Home Internet Mobile Phone Employee Referral Program Leaves - Paternity Leave 4 Weeks Maternity Leave up to 26 weeks Bereavement Leave 5 calendar days About ICC in Takeda Takeda is leading a digital revolution We re not just transforming our company we re improving the lives of millions of patients who rely on our medicines every day As an organization we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization Li-Hybrid Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time
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