Regional CQV Director
4 weeks ago
At IPS, you’ll apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences.
We are actively seeking a Regional CQV Director - APAC to lead our growth efforts based in Singapore . This newly created role reflects IPS' dedication to delivering exceptional solutions while solidifying its position as a global industry leader. You will report to the Managing Director, Matthew Shippey, who was recently appointed and has extensive experience in the pharmaceutical, data center, renewable energy, and manufacturing sectors. His visionary approach and business-oriented mindset have consistently driven exceptional results and we want you to be a part of this new exciting growth journey in Singapore.
In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also lead, mentor, train, and manage a team of compliance staff assigned to the respective regional office. You will support business development activities including sales calls, proposal writing, lead generation, etc. Additionally, you will track staff utilization, coordinate staff assignments to projects, and assist in the identification, recruiting, interviewing, and hiring of compliance staff. Finally, you will maintain client relationships and is responsible for the overall delivery of projects in the assigned region, follow IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements.
Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights
Qualifications & Requirements
Bachelor’s degree in Engineering, or a related discipline or an equivalent technical degree. 15+ years 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, Processes, Computer Systems, 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 APAC /EU /US FDA and international Standards and guidance (ASTM, ICH, ISPE, etc.).
About Us
IPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products. Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industries. With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East.
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.
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