Manager Qc Compliance

vor 8 Stunden

YverdonlesBains, Schweiz Incyte Corporation Vollzeit

**SUMMARY**

The Manager QC Compliance is responsible for ensuring QC processes are compliant to regulatory and Incyte requirements as well as contributing to their continuous improvement based on best industry practices. The activities include (but is not limited to) responsibility for managing the main following processes within QC: deviations, investigations, change controls, data integrity, analytical software audit trail review, periodic review and training. Additional tasks are the management of inspections, audits and regulatory surveillance (performs impact assessment), the reporting of quality processes metrics.

**DUTIES AND RESPONSABILITIES**
- Support the QC team as a manager and as an expert of the compliance aspect for QC
- Manage, investigate and close events and deviations in support of SMEs in QC
- Manage and support the timely and effective completion of deviations, non-conformances, investigations, change controls and CAPAs, periodic reviews
- Drive, monitor and assure delivery of the Data Integrity Plan, including DI risk-analysis assessment and action plan, and periodically report status / progress to leadership team. Support Escalation
- Lead EM and Utilities Committee as a member of QC: update and present the trend analysis, identify any negative trends and propose corrective actions with the support of Manufacturing and Engineering Department and with QA engineering.
- Continuously improve data integrity knowledge base and understanding: detect and mitigate DI risks by working with SMEs, identify training needs and deliver training
- Author, review, approve and maintain life cycle of relevant Standard Operating Procedures, Work Instructions, and all other quality documents related to areas of responsibility, as well as support other areas as required
- Act as a mentor to more junior team members and lead by example to ensure timely activity, and proactively propose problem resolution
- Ensure that the QC team is well trained in a timely manner
- Act within compliance and legal requirements as well as within company guidelines
- Manage health authority inspections, internal and corporate audits, response to observations
- Own the assessment of regulatory and pharmacopoeia updates linked to QC activities
- Contribute positively to a strong culture of proactive quality and continuous improvement, business integrity and ethics
- Is the Quality champion for the QC department, responsible to drive a high level of compliance in the department:
- Monitor and report quality compliance indicators for the QC department
- Chair Quality compliance reviews in the department
- Implement quality compliance initiatives in the department in collaboration with QA and the Bioplant quality champion community
- Coach and support other team members for quality compliance matters (such as deviation and changes management)
- Coordinate the department inspection readiness
- Delegate to: Director Quality Control

**REQUIREMENTS**
- Biotechnology or pharmaceutical MSc degree preferred (e.g. Swiss HES, University, Engineering School) or relevant experience in the biotech industry.
- 10 years’ experience in the biotech, pharmaceutical or chemical environment
- Experience with Quality systems such as Deviation, CAPA, Change control systems required
- Hands-on experience of equipment software qualification
- Demonstrated, solid hands on experience of Quality control - typically 5-10 years
- Experience in troubleshooting, investigation, root cause analysis in a cGMP environment required
- Leadership, ability to build trust and create collaborative environment and relationships
- Ability to work in a fast paced - highly regulated environment.
- Team work oriented mindset
- French (fluent) and English (good level - C1).

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority (if applicable).

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