Quality and Compliance Lead

2 weeks ago

Burlington, Canada Boehringer Ingelheim Full time

**Quality and Compliance Lead**
**-**
**235894**

**OUR COMPANY**

**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:

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