Manager Pharma Compliance
You will be primarily responsible for managing various services related to Computerised System Validation (CSV), Science and Risk Based Validation Approach for Computerised equipment, administration and people management in the CMC, Infrastructure and Regions Compliance Reporting teams. You are expected to have a broader perspective of organisational strategy and good understanding of industry/compliance trends and find innovative ways to leverage the knowledge and support the long term strategy and growth of the department. You will be able to understand the process landscape across and align and standardise the best practices and optimise processes.
Furthermore, you will be responsible to perform daily management and leadership of the team, within the rules and regulations of GBS and in coordination with Global IT in Denmark. We expect you to involve in resource planning and actively participate in various forums that impact the collaborations and success of services strategy e.g. CMC Steering Group, SM Reference Group, Quality Forums, Plan Meetings etc. You will be responsible to drive strong collaboration between System management organisation, QA organisations and Process Office to ensure alignment of compliance needs. We expect you to work closely with management team to set up strategic initiatives in ITSS IN to support the overall ITSS strategy.
Addition to the above, you will be responsible for reviewing progress on key activities, such as strategic IT initiatives, compliance, audit readiness and implement mitigating actions as required and lead the team as WAY role model in all aspects of People Management to achieve quality deliverables and continuous improvements. You will be responsible for handling and preparing budget, follow up for CMC and involve in vendor management, follow up on vendor deliverables, handling escalations, suggestions, contracts and estimations. You will be responsible for managing validation requirements, developing and negotiating supplier contracts, and responsible to ensure validation capabilities and service quality are standardised and uniform across projects delivered. you will be involved in organising trainings from validation SMEs on new developments/learnings.
Below skills are required to have:
• M.Sc. or M.C.A or B.Sc. or similar graduate degree in relevant field (Computer Science, IT Quality)
• 10+ years of people management experience within pharmaceutical or other relevant industry, including hiring, appraising and development responsibility of people
• 10+ years of experience in managing Quality & compliance deliverables in service level based setup
• 10+ years of experience with IT system management and/or IT project related work, i.e. development, operation and maintenance of IT systems
• Strong interpersonal, analytical, global communication and collaboration skills
• Ability to represent relations with users and external stakeholders
• Knowledge of and experience with regulatory requirements (e.g. GMP, 21 CFR Part 11), self-driven to ensure that the IT systems will pass inspections from the authorities without problems
• Quality mind-set and should be able to advice/challenge decisions in the interest of quality
• Should be up to date expert knowledge of anticipated regulations from the authorities and codes/standards within the IT disciplines
• Strong understanding of industry trends and technology to be leveraged to improve processes and support value addition
• Foster innovation and continuous improvement in the department
• Ability to see the ‘big’ picture and accordingly translate into relevant strategy and operations
• Manage stakeholders, upper management as well as teams expectations in terms of quality, delivery and growth
• Lead by example and walk the talk on all aspects of people management – should be inspirational and motivational
• Live the company values and be a role model to employees
• Continuously develop the talents, and all the team members