Head Quality Medicine (Burlington, CA, Canada, Ontario)

The Position

Defines, shapes and leads the Regional Operating Unit R(OPU) Medicine Quality Management System (QMS) consistently, based on and in accordance with the global Boehringer Ingelheim Medicine Quality Management System throughout drug development to maximize patient safety, data integrity, fast and efficient market authorizations and maintenance of our licenses.

Formulates and is responsible for goals and objectives for the R/OPU QM in accordance with the given global strategy, vision and goals. Contribute and provide insights for global goals.

Leads the (R)OPU to manage quality and compliance topics in order to ensure quality of our products and compliance with internal and external regulations.

Leads continuous development and evolution of the QMS and proactively identifies risks and mitigation measures for all aspects of the QMS including activities for end-to-end inspection management, corrective / preventive actions, supplier oversight as well as oversight of local regulations.

Responsible for R/OPU QM resource and budget planning

Active membership of the (R)OPU medical leadership team to ensure alignment of Quality topics across functions, consistent implementation of the QMS and regular review of the quality status and risks in the (R)OPU.

This job posting is for an existing vacant position.

Responsibilities

Accountable for shaping the (R)OPU Medicine Quality Management System development, implementation and ongoing maintenance and oversight.

Lead Boehringer Ingelheim  Medicine to meet regulatory requirements through:  Leading and ensuring that quality and compliance standards are understood and proactively embedded within the (R)OPU.

Driving consistent and harmonized implementation and continuous improvement of the QMS within Medicine.

Shaping a feedback culture on all aspects of the QMS including Non compliances, CAPAs, inspection findings and audits in order to address risks and compliance gaps.

Providing data driven insights

Leads and Manages the (R)OPU QM Team and resource needs

Responsible for the organizational structure, appropriate resource and budget planning.

Shapes the professional and disciplinary development of assigned employees, and ensures that they have relevant skills and competencies to fulfill their role through coaching and talent development empowering them to understand the quality and compliance requirements and implications for their business area.

For those QM (R)OPUs with colleagues in Global Quality Medicine role: Ensure alignment with the respective global head to actively support personal development and talent management.

For auditors: Head auditing to uphold auditors’ independence.

Responsible for identifying real and potential risks associated with all aspects of the QMS and proposing and implementing solutions to these fundamental and strategically relevant risks.

Explore & realize innovative opportunities to enhance the QMS

Shapes and provides the framework for Functional Quality (FQAs)Assessments

Leads inspections end to end and including timely responses to findings.

Drives a learning organisation by ensuring all aspects of Services and Solutions are embeded into the organisation

Leads innovation and provides data driven insights to the organization.

Responsible for the R/OPU Quality Management Review

Lead the identification and proactive communication of relevant QMS topics from the (R)OPU via the appropriate communication/escalation channels, in order to ensure global oversight of quality topics and continuously improve the global quality management system for Boehringer Ingelheim Medicine.

As a Quality and Compliance Subject matter expert, contribute to the definition of the strategic goals of other organizationa/functional units and also the QM Global goals.

Lead and foster a Quality Culture to meet current business needs and support future innovation and regulatory changes.

Engage in relevant industry associations / work groups in order to bring in industry best practices in house and contribute to the definition of future industry best practices.

Responsible for technical expertise outside the company as required.

Responsible for Quality and Compliance technical expertise in strategic and cross-organizational specialist topics/projects.

Foster cross functional and divisional quality discussions to identify synergies and optimize the global Boehringer Ingelheim quality management system. This includes interactions with other (R)OPU quality and compliance organizations (e.g. Healthcare compliance, Commercial Quality, etc.).

This position is based in the Burlington, Ontario office located at 5180 South Service Road and is  flexible . Employees in flexible roles are required to be at the office a minimum of 50% of the time each month and must report to the office when requested and required by their Manager/Department.

Requirements

University degree (Master's or comparable degree) in a scientific discipline e.g.  Pharmacology or other life science.

Expert in ICH GcP and applicable regulations (10+ years’ experience in clinical trial management and/or in depth knowledge of clinical development process) OR

Expert in ICH GvP and applicable regulations (10+ years’ experience in pharmacovigilance and/or in depth knowledge of pharmacovigilance processes)

Knowledge in applicable company processes, procedures and systems

Significant direct experience with / participation in regulatory authority inspections and interacting with Regulatory authorities

Experience with working within a highly matrix environment / organization

Experience of coaching / developing others and leading teams (8+ years)

Demonstrate experience with design, implementation and / or management of Quality Management Systems or elements thereof

Knowledge:

QM processes and functional processes: level of understanding such that the  role provides appropriate Quality and compliance related advice in relation to the processes

QMS: understanding of the sub-elements of the QMS and how they link together such that the role can fulfil QMS related accountability (see above)

Quality by Design: in depth knowledge of QbD approaches such that role can provide appropriate QbD related advice in relation to QM and functional processes

Boehringer Ingelheim organization & strategy:  understand the  organization and our goals such that   the role can contribute to new strategies, goals or projects from a

Quality and Compliance perspective

R&D understanding: understand the overall drug development process and Boehringer Ingelheim  specific areas of focus (therapeutic areas) such that role can advise on adopting of innovative approaches across clinical development

Digital suppliers: understand digital suppliers such that the role can incorporate these topics whilst delivering accountabilities e.g. provide advice on risks to data integrity through use of specific supplier and suggest ways to mitigate these risks

New technologies: knowledge of specific technologies e.g. data collection technologies and the associated (potential) regulations, such that the role can provide advice in their use within the (R)OPU

External regulations: knowledge of the relevant regulatory requirements for QM and functional processes to be able to assess the risks for non-adherence to external regulations and provide mitigation strategies or how to address issues

Skills:

Communication skills: able to communicate effectively with all individuals across Boehringer Ingelheim  regardless of their position or relationship

Influencing & negotiating skills: able to clearly articulate options and their potential implications and reach an agreement with all individuals across Boehringer Ingelheim  regardless of their position or relationship

Leadership skills: able to lead by delegating and empowering others to lead whilst maintaining overall leadership and oversight

Data analytics: able to perform simple analyses and interpretation of data in order to support decision making and to identify recommendations

Critical thinking: able to draw reliable conclusions in order to make decisions or recommendations

Presentation skills: able to design and deliver effective presentations to achieve the required outcomes needed

Risk management: able to identify and manage risks associated with cross functional projects and Medicine processes effectively

Project management: able to apply project management techniques to lead and deliver local or regional projects

QM Behaviours: able to adopt and incorporate QM expected Behaviours into how the role delivers their accountabilities including:  being pragmatic, solution oriented, collaborative, customer focused and proactive

Ability to travel regionally and internationally as needed

Total rewards

We offer competitive total rewards that includes a generous amount of paid time off (vacation, personal days, contingency paid time off days for Long Term Contract Employees), comprehensive and flexible benefits plan, Defined Contribution Pension Plan with company matching of RRSPs, Employee and Family Assistance Plan, employee and leadership development programs, and programs to support overall health and wellness for employees.

Our total rewards philosophy reflects and recognizes employee contributions to the company.

Visit  https://www.boehringer-ingelheim.com/ca/careers/explore-our-company/benefits-rewards

The salary range for this position is from $161,220 to $211,220. Performance, relevant experience and competency in the role will be a key factor in driving the compensation offered.  In addition, this position is eligible for a variable bonus target opportunity of 20% of the annual base salary.

READY TO APPLY?

Click the "Apply Now" button below to submit your application.

We thank all applicants for their interest in our company.  Please note that only candidates selected for an interview will be contacted.

Boehringer Ingelheim Canada is committed to providing accommodations for people with disabilities to support their participation in all aspects of the recruitment and selection process.  If you require accommodation, we will work with you to meet your needs.

Boehringer Ingelheim Canada does not use artificial intelligence to screen, assess, or select applicants in the recruitment process.

DEADLINE FOR APPLICATIONS

Applications for this position will be accepted until August 11, 2026.

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