Job Description

OUR COMPANY

Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. More than 52,000 employees serve over 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. The Canadian headquarters of Boehringer Ingelheim was established in 1972 in Montreal, Quebec and is now located in Burlington, Ontario. Boehringer Ingelheim employs approximately 500 people across Canada. Learn more at .

THE POSITION

The Quality Medicine - Quality and Compliance Lead (QCL) plays a critical role in the implementation and management of pro-active, fit for purpose Quality Management Systems (QMS) across the company\'s drug/device lifecycle.

This is achieved by providing pragmatic and expert quality and compliance consultancy to enable fast and efficient research and development, market authorizations and to maintain licenses for our portfolio of medicinal products.

The position provides critical assessments of Medicine activities with company procedures, GvP/GCP, ICH guidelines and applicable regulations; identifies and assesses areas of risk; proposes corrective and preventative actions, leads the development and implementation of process improvements.

Responsibilities

Quality Improvement:

• Identify areas for improvement and participate/lead quality improvement projects.
• Leads the development/revision of medical process and procedural documents.

Audit process support:

• Provide expert guidance to auditee, as appropriate, including:

• Responding to observation
• Facilitating the handling of major and critical non-compliances.
• Ensuring action commitments are adhered to, tracked, and followed up.

Regulatory Inspection support:

• Act as the BI point of contact and coordinate the conduct of regulatory authority inspections
• Provide expert guidance relating to optimized inspection readiness and lead inspection preparation activities.
• Ensure inspection findings are appropriately addressed, response provided and adequately followed up.

Compliance expert:

• Provide GxP/Regulatory/Procedural guidance, consultation, coaching, mentoring, including sharing of best practices.
• Partners with stakeholders in the investigations and development of CAPA plans related to non-compliances.
• Proactively identifies significant Quality/Compliance related risks in Medicine Activities and participates in the development of mitigating actions.
• Analyze non-compliance trends and provide periodic updates to management of the country/region.

Quality Management of Medicine Service Providers:

• Participate in the qualification process for new Clinical Research Organizations (CROs)/Service Providers, in collaboration with other functions.
• Ensure Oversight plans are in place to address Quality related risks and the development of mitigating actions.
• Engage business partners in the investigations and development of CAPA plans related to CRO/Service Provider non-compliances.

Requirements

• Master\'s degree preferred or Bachelors in a life science or other scientific discipline with several years of work experience

Knowledge:

• QM processes and functional processes: level of understanding such role can provide appropriate Quality and compliance related advice in relation to the QM processes
• QMS: understanding of the sub-elements of QMS and how they link together such that 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
• R&D understanding: understand overall drug development process and BI specific areas of focus (therapeutic areas) such that role can incorporate these topics whilst delivering accountabilities
• Digital suppliers: understand digital supplier such that 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 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 clearly and concisely with all individuals across BI 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 BI regardless of their position or relationship
• Leadership skills: able to lead Quality and Compliance topics and teams (including matrix or project teams) effectively to deliver the responsibilities effectively
• Data analytics: able to perform simple analyses and interpretation of data in order to enable 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
• Risk management: able to identify and manage risks 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 role delivers its accountabilities including: being pragmatic, solution oriented, collaborative, customer focused, proactive assertive and decisive
• Ability to travel regionally and internationally as needed

WHY BOEHRINGER INGELHEIM?

With us, you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.

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

At Boehringer Ingelheim we embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.

Remote work options (if applicable for this role), will be addressed with candidates who are selected to participate in the interview process.

Want to learn more? Visit

READY TO APPLY?

Visit

Create an Account and log-in to apply on-line.

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

BI 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.

DEADLINE FOR APPLICATIONS
Applications for this position will be accepted until May 31, 2023 (6pm EST)

Not exactly the position you are looking for but have someone else in mind? Share it via the button on the bottom of the page with friends or colleagues who might be interested.

Boehringer Ingelheim