Validation and Compliance Manager

Job Description

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented Validation and Compliance Manager to lead the Commissioning, Qualification, and Validation (CQV) Team across the DACH region.

Reporting to the CQV Director for the EMEA region, you will lead the evolution of compliance services as a key element of IPS EMEA's expertise and service offering. You'll also manage the application and improvement of internal quality practices. 

Additional Responsibilities

• Performs cGMP compliance consulting and project-based services.
• Acts as EMEA SME for Compliance services.
• Leads, mentors, trains, and manages a team of European-based compliance staff.
• Supports business development activities.
• Supports the identification, recruiting, interviewing, and hiring of compliance staff.
• Maintains client relationships and is responsible for the overall delivery of assigned projects from a compliance perspective.
• Follows IPS and client standards and requirements, overall good industry practices for CQV services, and regulatory requirements.
• Directly responsible for the successful delivery of compliance projects to IPS’ clients in EMEA and for oversight of project budgets, schedules, deliverables, quality & client satisfaction.
• Maintains contact with respective clients to assure “customer satisfaction.”
• Leads compliance service activities and oversees EMEA activities for compliance consulting, commissioning, and validation.
• Supports IPS Corporate and Divisional business development strategies and activities.
• Develops and maintains “industry presence” and personal network to develop opportunities.
• Works with IPS Quality Manager to develop and apply quality practices for EMEA project deliverables and business practices.
• In conjunction with the Quality Manager, performs project audits to ensure all project goals are being met
• Promotes efficiency in staff utilization.
• Manages and assigns regional resources to meet project requirements in conjunction with other Regional Managers and IPS disciplines to maintain targeted/budgeted utilization.
• Prepares workload forecasts to support staffing management.
• Leads, mentors, trains, and manages a 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 CQV deliverable activities, audits, and other compliance services as required to meet project requirements and personal utilization goals.
• Works with potential new and existing clients to initiate projects following current industry practices.
• Performs strategic and master planning activities to ensure projects are initiated and started “on the right foot.”
• Ensures that IPS Corporate and Divisional directives, programs, and values are implemented and maintained at a Regional Level.
  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/compliance and encourages networking, peer presentations, and involvement of self and staff in networking and educational programs.  
• Actively participates in relevant professional societies and pursues presentation/training opportunities.
• Stays current (training, reading, professional organization involvement) with industry trends and current CQV methodologies.
• Promotes a friendly and efficient work environment, which rewards achievement and recognizes teamwork and champions technical advancement, in support of IPS 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.).
• Provides working knowledge in the delivery of technical projects in these areas.  
• Works in conjunction with EMEA Management Team to recruit new staff members.
  Special projects as assigned.

Qualifications & Requirements

• Bachelor of Science in Engineering or Science, or relevant experience.
• German language proficiency at a minimum B2 level.
• 10+ years of experience in the Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, validation, or QA industries. Experience in the writing and execution of IQ, OQ, and PQ protocols for GMP Utilities, equipment, systems, and software.
• Experience with Cleaning, Process, computer systems, 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 EU and U.S. FDA.
• Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
• Personal skills and traits include:
  • Sense of urgency and responsiveness
  • Team player
  • Able to multitask
  • Effective time management
  • Able to effectively prioritize
  • Excellent interpersonal skills
  • Attention to detail
  • Excellent customer service skills

About Us

IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That’s only possible when we care as much as our clients do.

Specialties

Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.

All qualified applicants will receive consideration for employment at IPS without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.

#LI-KS1

Connect With Us!

If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!