Job Description

IPS is hiring! We are looking for a talented Regional Manager – Qualification & Commissioning to join our growing EMEA Commissioning, Qualification and Validation (CQV) team to be based at our newest EMEA office, located in Dublin, Ireland.

 

Performs cGMP compliance based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Leads, mentors, trains and manages team of compliance staff assigned to the respective regional office. Supports business development activities including sales calls, proposal writing, lead generation, etc. Tracks staff utilization and coordinates staff assignments to projects. Assists in the identification, recruiting, interviewing and hiring of compliance staff. Maintains client relationships and responsible for overall delivery of projects in the assigned region. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements. Acts as working manager and performs consulting and project assignments as required.

 

Job Duties and Responsibilities

  • Directly responsible for the successful delivery of compliance projects to IPS’ clients in the designated region. Responsible for oversight of project budgets, schedules, deliverables, quality, client satisfaction, etc. Maintains contact with respective clients to assure “customer satisfaction.”
  • Leads compliance service activities and oversees region specific activities for compliance consulting, commissioning and validation.
  • Supports IPS Corporate and Divisional business development strategies and activities. Includes lead generation follow-up, attending bid meetings, prepare proposals, proposal presentations, etc. Develops and maintains “industry presence” and personal network to develop opportunities.
  • Works with IPS Quality Manager to develop and apply quality practices for all project deliverables and business practices. In conjunction with the Quality Manager, performs project audits to ensure all project goals are being met and compliance services are offered as a value added product to IPS’ clients.
  • Promotes efficiency in staff utilization. Manages and assigns regional resources to meet  project requirements. Works with other Regional Managers and other IPS disciplines to maintain targeted/budgeted utilization. Tracks staff assignments, makes resource projections and makes necessary adjustments as required. Prepares workload forecasts to support staffing management.
  • Leads, mentors, trains and manages team of compliance staff assigned to the respective regional office.
  • Assists and mentors staff to set performance and career goals. Provides routine feedback and conducts formal time based performance reviews. Implements corrective action plans as required.
  • Generates and performs C/Q/V deliverable activities, audits and other compliance services as required, to meet project requirements and personal billability goals. Works with potential new and existing clients to initiate projects following current industry practices. Performs strategic and master planning activities to assure projects are initiated/started “on the right foot.”
  • Ensures that IPS Corporate and Divisional directives, programs and values are implemented and maintained at a Regional Level.

Additional Job Duties and Skills

  • Leads by example. Deems the respect of upper management, peers and subordinates. Empowers staff to succeed.
  • Supports and deploys technical training programs that assure competency and advancement levels to support corporate goals.
  • Maintains a high level of professionalism in validation and compliance and encourage networking, peer presentations and involvement of self and staff in networking and educational programs.
  • Makes salary and compensation recommendations for company-wide compliance professionals and reviews performance of local staff. Reviews/recommends staffing additions/separations. Performs and supports employee performance reviews.
  • Supports the Divisional Operations Director in setting regional business goals and budgets for each fiscal planning year.
  • Actively participates in relevant professional societies and pursues presentation/training opportunities.
    Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies.
  • Promotes a friendly and efficient work environment, which rewards achievement and recognizes teamwork and champion’s technical advancement, in support of our Corporate goals.
  • Demonstrated/recognized areas of expertise by industry (Sterile, OSD, Biotech, Medical Device), by equipment/systems (lyophilizers, autoclaves, packaging, compression/encapsulation, etc.), or by validation activity (process, cleaning, CSV, methods, etc.). Provide working knowledge in the delivery of technical projects in these areas.
  • Maintain professional conduct and deliver services in a professional and acceptable fashion.
  • Works in conjunction with the Director of Operations in recruiting new staff members and promoting IPS to potential hires.
  • Special projects as assigned.

Qualifications & Requirements

  • Bachelor of Science in Engineering or Science.
  • Extensive experience of Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation or QA projects.
  • Experience in writing and execution of IQ, OQ and PQ protocols for GMP Utilities, Equipment, Systems and Software.
  • Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes is beneficial.
  • General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and GMP regulations within the E.U. and U.S. FDA.
  • Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).

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