Regional Director - CQV

Overview

Lead regional CQV team, deliver GMP compliance projects, drive business development.

Key Responsibilities

• resource allocation
• quality assurance
• compliance audits
• strategic planning
• technical training
• client relations

Tasks

-Prepare workload forecasts to support staffing management. -Work with potential new and existing clients to initiate projects following current industry practices. -Lead, mentor, train, and manage a team of compliance staff assigned to the respective regional office. -Track staff assignments, make resource projections, and make necessary adjustments as required. -Work with the CQV management team to develop and apply quality practices for all project deliverables and business practices. -Perform strategic and master planning activities to ensure projects are initiated/started “on the right foot”. -Support business development strategies and activities, such as lead generation follow-up, attending bid meetings, preparing proposals, and proposal presentations. -Manage and assign regional resources to meet project requirements. -Generate and perform C/Q/V deliverable activities, audits, and other compliance services as required, to meet project requirements and personal billability goals. -Work with other Regional Managers and other IPS disciplines to maintain targeted/budgeted utilization. -Perform project audits to ensure all project goals are being met and compliance services are offered as a value-added product to IPS clients. -Support and deploy technical training programs that assure competency and advancement levels to support corporate goals. -You will visit Client sites and will be required to adhere to stated safety rules. -Maintain contact with respective clients to assure “customer satisfaction”. -Maintain successful delivery of compliance projects to IPS clients in the designated region. -Lead compliance service activities and oversee region-specific activities for compliance consulting, commissioning, and validation. -Oversee project budgets, schedules, deliverables, quality, client satisfaction, etc. -Promote a friendly and efficient work environment, that rewards achievement, recognizes teamwork, and champions technical advancement. -Promote efficiency in staff utilization.

Requirements

• bachelor's
• risk-based
• validation
• gmp
• 10+ years
• pharma

What You Bring

-This position will have up to 50% travel to the site, or as required by the assigned project or sales opportunities. -Bachelor’s degree in Engineering, a related discipline, or an equivalent technical degree. -Experience with Risk-Based Approach to Commissioning and Qualification. -Overnight travel or staying in the city of the Client’s location is possible depending on the assignment. -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 E.U. and U.S. FDA and international Standards and guidance (ASTM, ICH, ISPE, etc.). -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. -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.).

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Benefits

-Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.

About Ips-Integrated Project Services

-Founded with the vision of delivering exceptional project solutions, the company is a trusted partner in the global construction and engineering sector. -From concept to completion, the company offers comprehensive services across various industries, including industrial, energy, infrastructure, and commercial sectors. -The company has a rich history of delivering large-scale, complex projects, with a focus on high-quality standards, safety, and sustainability. -Specializing in end-to-end project delivery, the company ensures that projects are managed efficiently, from initial planning through to construction and commissioning. -Notable for its ability to handle both small-scale and large-scale ventures, the company is recognized for its expertise in managing projects for major players in energy and industrial markets. -The company's deep technical expertise allows them to bring innovative solutions to life, working across sectors like nuclear, water resources, and heavy civil engineering. -With a solid track record in the design and build of cutting-edge facilities, the company stands out for its dedication to technical excellence and client satisfaction.

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