Regional Director – CQV

Job title:

Regional Director – CQV

Company

Integrated Project Services

Job description

Job Description:Job DescriptionAt IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking to hire a CQV Regional Manager to lead our Canadian team in our Vaughn, Ontario office.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 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.What You’ll Do

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

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, a related discipline, or an equivalent technical degree.
• 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, 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.).
• 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.).

Preferred Qualifications

• Experience with Risk-Based Approach to Commissioning and Qualification.

Safety

• This position will have up to 50% travel to the site, or as required by the assigned project or sales opportunities.
• You may be assigned to a client site for an extended time.
• Overnight travel or staying in the city of the Client’s location is possible depending on the assignment.
• Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
• You will visit Client sites and will be required to adhere to stated safety rules.
• This position is a safety-sensitive position.

The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other “non-administrative” areas.
About UsIPS, 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.SpecialtiesProcess 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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Expected salary

Location

Vaughan, ON

Job date

Sun, 13 Oct 2024 01:46:14 GMT

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