Manager, Continuous Improvement

Brunel

North Fork, CA, USA Remote Job

Nov 18

About this role: Manager, Continuous Improvement
About this role: Manager, Continuous Improvement

Introduction

We’re hiring a top talent Manager, Continuous Improvement, for a Global and innovative pharmaceutical company in Toronto for a one-year contract.

This position will support the Bioprocess Research and Development (BRD) team through leading the application of specialist expertise and influence of strategies in alignment with BRD’s strategies, goals and Designed Knowledge Management systems (DKMs). Administers and maintains relevant supporting systems.

This role requires collaboration with BRD personnel other personnel across the site as well as alignment with key stakeholders globally. Continuous improvement and demonstration of Subject Matter Expertise in their area of expertise is also expected from this position.

Responsibilities

Specialist: Lead application of expertise and influence strategies related to effective deviation management and continuous improvement to help BRD advance its Mission.

Collaborate with R&D SQO, SME’s, platform management and frontline staff, as required.
Participate, contribute or lead QN investigations where BRD is impacted or impacting another area (ARD, IO)
Develop investigation strategy and required collaborators / expertise and manage contributions from other departments (ARD, IO)
Facilitate identification of root cause
Facilitate deviation related CAPA definition and responsible for general oversight and monitoring of QN related CAPAs to assess effectiveness.
Responsible for on-time completion of quality deviation reports and management of deviation review process
Electronically sign off deviations
Representative for investigations during GMP inspections, as required.

Sphere of Influence/Impact: Collaborate/coordinate work across BRD and site. Liaise across global teams.

Define and implement process to triage BRD deviations based upon risk and impact
Identify recurrent issues or themes and work across BRD, site and globally (as relevant) to identify and develop process improvement plans to remediate quality risks and drive continuous improvement.
Review non-CMP platform deviation reports to ensure best practices applied and transversal understanding of BRD deviations.
Promote site practices or current best practices where appropriate (e.g. use of appropriate deviation report templates)
Provide weekly quality metric reports to enable BRD teams to proactively manage quality performance
Lead the execution and completion of DKMs for projects and non-project work.
Facilitate collaborative problem solving within BRD to achieve continuous improvement and risk reduction leading to improved performance and DKM achievement.

Requirements
Requirements

Requirements

Holds a Bachelor of Science degree with some experience or a Master of Science degree
6 years of relevant industry experience would be an asset
Solid knowledge and demonstrated aptitude of current Quality Notification processes, systems and requirements.
A broad understanding of BRD production process, ARD processes/systems and the Quality Operations processes/systems.
Strong knowledge and understanding of GMPs are critical as the position requires interaction with GMP areas such as BRD production and stability program, QO and ARD analytical testing labs as well as the R&D SQO team.
Proficient in following software: Outlook, PowerPoint, Word, Excel and Visio. Specialized software: SAP, Qlikview, QeDoc, ReD and R&D Trackwise for CCRs and CAPA. Supplementary: ProCal, Rapid Pharma, Master.
Effective communication skills are required; this individual is required to communicate clearly & concisely at all levels.
Analytical problem-solving skills are required, this individual will be required to use root cause analysis techniques to determine the cause of problems.
Creative problem-solving skills are required, this individual will be required to work with people at all levels during troubleshooting sessions
Strong facilitation and conflict resolution skills are required to help manage team dynamics and influence people that this individual has no authority over.
Effective time management skills to recognize and attend to appropriate priorities.
Good presentation skills and ability to publish metrics/reports.
Demonstrate leadership and possess initiative and ability to lead or drive processes or projects to completion.
Flexible, creative and resourceful to accommodate various work schedules of investigation stakeholders while keeping on track for closure dates.

Benefits
Benefits

What We Offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About Brunel
About Brunel

About Us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

How to apply
Do you have questions?

If you have questions or would like to discuss the details of this role, please contact Quynh Vo quoting publication number:
PUB329505

Account manager

Quynh Vo
Brunel Canada - Calgary
q.vo@brunel.net

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