Regional Director - CQV

CA-ON-Vaughan

Integrated Project Services, Inc

Req #: 8898
Type: Regular Full-Time
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Integrated Project Services, LLC

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				Overview:

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.

Responsibilities:

At 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:

* 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.

IPS-Integrated Project Services, ULC. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. If you require accommodation during the recruitment process, please contact Ashley Patience-Abgao at apabgao@ipsdb.com and we will work with you to ensure that appropriate arrangements are made.

All interviews are conducted either in person or virtually, with video required.
			
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