The Position:

The Quality and Compliance Lead is the Quality and Compliance expert and drives GCP/GPV topics across the organization to proactively manage Quality and Compliance across the drug/device lifecycle.

 

The Role:

Leads the organization to identify and mitigate risks throughout the drug/device lifecycle to ensure patient safety and data integrity.Initiates and manages any quality and compliance topics to continuously improve our Quality Management System.Provides quality and compliance consultancy to enable fast and efficient research and development, market authorizations, and maintain licenses for our portfolio of products within the region.Contributes local insights into the Global Quality Medicine Strategy and executes the strategy at a regional level.Acts locally and thinks globally.

 

Tasks and Responsibilities:

 

Quality Strategy and Governance:

Develop and maintain all aspects of the global Quality Management System and tailor it to the region to comply with local regulatory requirements.Lead with the Head of QM the preparation of Quality Management Review reports and meetings.Actively collaborate in the setup, development, and implementation of quality objectives and Quality plans.Deputize for the Regional Head of QM where applicable.

 

Culture and Organization:

Be a quality & compliance consultant and work collaboratively as a solution-oriented, pragmatic partner to the Medicine functions and other applicable business partners, leading them to understand the quality and compliance requirements and implications for their business area.Assess the impact of Regulatory Intelligence Network (RIN) changes on Quality and Compliance processes and act and escalate topics accordingly.Lead the understanding of Quality Culture by ensuring quality and compliance standards are understood and embedded into processes and practices early (Quality by Design).Actively involve and participate in local/global/regional activities/topics and projects.

 

Processes and Procedures:

Lead the implementation and maintenance of global procedures in a pragmatic, clear, and concise way and ensure adherence to the local regulatory and business requirements. For example, lead the design/creation/retirement of local documents/assets as required.Collaborate with Medicine functions in conducting Regional learning needs analysis (training, qualification).Communicate global changes into the region as required to enable the adoption of new ways of working.Verify the translation of relevant topics as required.Initiate updates of relevant process descriptions and guidelines as needed.

 

Regulatory Inspections:

Lead inspections end-to-end (inspection preparation, conduct, and post-inspection management), representing the company's compliance position to regulatory authorities during inspections and ensuring inspection findings are addressed and responses provided.Ensure any lessons learned are implemented.

 

Audits:

Contribute to audits by inputting into the annual audit planning and ensuring audit findings are appropriately investigated and actions are effectively implemented.Ensure that lessons learned are implemented.Conduct audit activities as lead, co-, or company's responsible auditor provided appropriate qualification is available, upon request (assignment) and under the oversight of the global auditing leadership team.

 

Supplier Management:

Define requirements for services needed by the region in collaboration with Medicine Function.Manage and oversee suppliers effectively within the region, liaising with Global Vendor Compliance Manager stakeholders (e.g., Medicine, Sourcing, Legal, and Commercial Quality) from site qualification to the process end and Non-Compliances/Corrective Action/Preventive Action (CAPA) Management.Perform periodic reviews of region-specific suppliers.

 

The Compliance Manager executes the supplier management tasks and activities (qualification, oversight, and termination activities) for the assigned suppliers in their region, as per global process.

 

Risk and Issue Management:

 

Quality Improvement:

Continuously review and evaluate standards and processes for potential compliance gaps/risks/near misses in accordance with regulatory and legal requirements, e.g., use Functional Quality Assessments to communicate globally and update as required.Provide quality analysis, trending, and optimization capabilities across Medicine Functions.

 

Management of Non-Compliances:

Lead as the subject matter expert (in partnership with the business key stakeholders) in Non-Compliance management and Issue Management processes. Ensure effective triaging, root cause analysis investigation, and CAPA development delivering robust CAPAs.Be a proactive member of the project team and contribute holistic Quality and Compliance input as a Project Quality and Compliance Lead (PQCL) at the project/trial level, provided appropriate qualification is available and under the oversight of global. Requirements:Mandatory:Graduate in Chemistry, Biochemistry, Pharmacy, Engineering (related fields).At least 3 years of experience in Quality Management in the Pharma Industry.GvP & GCP Knowledge and expertise.Regulatory audits management.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.Project management: able to apply project management techniques to lead and deliver local or regional projects.Master's degree preferred or Bachelor's in a life science or other scientific discipline with several years of work experience. Desirable:Risk Management, knowledge management.