Job Description

At IPS, you\xe2\x80\x99ll apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are currently seeking a Regional CQV Director to lead our APAC growth efforts.

Our team of international compliance experts apply practical industry experience and scientific methodologies for risk, audit, remediation, and quality system development to commission, qualify, and validate technically complex projects throughout the world.

The Regional CQV Director will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS\xe2\x80\x99 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.

Key Activities & Responsibilities

• Directly responsible for the successful delivery of compliance projects to IPS\xe2\x80\x99 clients in the designated region.
• Responsible for oversight of project budgets, schedules, deliverables, quality, client satisfaction, etc.
• Maintains contact with respective clients to assure \xe2\x80\x9ccustomer satisfaction\xe2\x80\x9d.
• Leads compliance service activities and oversees region specific activities for compliance consulting, commissioning, and validation.
• Supports business development strategies and activities.
• Includes lead generation follow-up, attending bid meetings, prepare proposals, proposal presentations, etc.
• Develops and maintains \xe2\x80\x9cindustry presence\xe2\x80\x9d and personal network to develop opportunities.
• Works with IPS CQV management team to develop and apply quality practices for all project deliverables and business practices.
• In conjunction with the CQV management team, performs project audits to ensure all project goals are being met and compliance services are offered as a value-added product to IPS\xe2\x80\x99 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 \xe2\x80\x9con the right foot\xe2\x80\x9d.
• 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 encourages networking, peer presentations and involvement of self and staff in networking and educational programs.
• Makes salary and compensation recommendations for regional compliance professionals and reviews performance of local staff.
• Reviews/recommends staffing additions/separations.
• Performs and supports employee performance reviews.
• 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\xe2\x80\x99s technical advancement, which supports our corporate goals.
• Demonstrated / recognized areas of expertise by industry (Sterile, OSD, Biotech, Medical Device), by equipment/systems (lyos, 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 Sr. Director, CQV in recruiting new staff members and promoting IPS to potential hires.

Qualifications & Requirements

• Bachelor\xe2\x80\x99s degree in Engineering, or a related discipline or an equivalent technical degree
• A minimum of 10 years (Manager) to 15 years (Director) of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA. Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software.
• Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes.
• Detailed experience in the discipline of GMP/Validation with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA and international Standards and guidance (ASTM, ICH, ISPE, etc.).

Company Overview

IPS-Integrated Project Services is a global leader in developing innovative and cost effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends and regulatory environment to successfully deliver capital projects and improve operations. For over thirty years, we have applied unique LEAN methodologies throughout the project life cycle, continually finding ways to do things better and more efficiently, delivering higher quality and controlling costs. With the newest acquisition of Linesight, IPS has over 2,700 professionals in 45+ offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East. Linesight specializes in cost, schedule, risk, program, and project management services in various market sectors, including datacenters, life sciences, and high-tech industrial.

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.

Attention Search Firms / Third Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via-email, the Internet or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.

Integrated Project Services