CQV Manager

IPS-Integrated Project Services; Frankfurt; On-site; EUR 110,000 - 150,000; Full time

Job summary

IPS is seeking a Validation and Compliance Manager to lead the CQV team across the DACH region. You will report to the CQV Director for the EMEA region and drive compliance services as a core element of IPS EMEA’s offerings.

The role requires extensive experience in pharmaceutical validation and regulatory compliance. You will oversee a European-based staff, ensure successful project delivery within scope and budget, and promote best practices in CQV and regulatory alignment.

Qualifications

• Bachelor of Science in Engineering or Science required.
• German language proficiency at least B2.
• Minimum 10 years in pharma/biotech/medical device design and validation.

Responsibilities

• Lead CQV team across EMEA and ensure project delivery.
• Perform cGMP compliance consulting and audits.
• Develop and apply quality practices with the Quality Manager.
• Mentor and manage compliance staff.
• Support business development activities.

Skills

CQV leadership

GMP compliance

Team management

German language proficiency

Regulatory knowledge

Education

Bachelor of Science in Engineering or Science

Tools

IQ/OQ/PQ protocols

MS Office

Job description

Job Description

IPS is hiring!We are looking foratalentedValidation and Compliance Managerto lead Commissioning, Qualification and Validation (CQV)Team across the DACH region.

Reporting to the CQV Director for the EMEA region, the Validation and Compliance Manager will lead the evolution of compliance services as a key element of IPS EMEA's expertise and service offering. This individual will also manage the application and improvement of internal qualitypractices.

• 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.

Duties and Responsibilities

• 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 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 assure 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 minimum B2 level.
• Minimum of 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 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 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 multi-task
• - 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.