QA Manager Combination Product and Device

Vor 2 Tagen

Basel, Schweiz ITech Consult Vollzeit

**QA Manager Combination Product and Device M/F/d)**

**Project**:
For our customer a big pharmaceutical company in Basel we are looking for QA Manager Combination Product and Device (M/F/d).

**Background**:
The Quality Project Manager position will provide in-depth Device Quality expertise for drug delivery systems (under development or commercial) to ensure compliance with applicable standards and regulations. The position will be a support of the Quality SPOC (single point of contact) for the Device Development and Device Industrialization project team.

**Tasks & Responsibilities**:

- Serve as the Quality SPOC (single point of contact) for allocated Device Development project and ensure all projects follow the applicable design control and risk management procedures
- Collaborate with all QA representatives from other functions to ensure Quality Robustness of the interface between the Drug Product and the Device Component forming the Combination Product
- Create and deploy Risk Management Plan / Report, actively participate up to facilitating FMEAs, define Delivery System specifications accordingly including Drug Product / Component interface, and ensure all necessary release GMP documentation are completed and in place
- Ensure and drive quality resolution for investigations related to the delivery system, and assessment of change controls. Represent department at Quality Review Board and Change Review Board meetings

**Must Haves**:

- BS degree in Life Sciences discipline or mechanical engineering, Graduate degree preferred
- Min. 2 years experience and hands on expertise in device quality or device development
- Understanding of the biotechnology industry and specifically combination products and working in a global environment preferred
- Sound knowledge of cGMPs and relevant international regulatory requirements (QSR; MDR; ISO13485, etc.)
- Well developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in
- Demonstrated problem solving and decision making skills including hands on working experience with tools Six Sigma / DMAIC is preferred
- Very motivated and willing to perform tasks with varying complexity
- Fluent in English, German is a plus

**Role: QA Manager Combination Product and Device (M/F/d)**

**Industrie: Pharma**

**Workplace: Basel (Home Office: max. 2 days per week)**

**Pensum: : 80 - 100%**

**Start : ASAP**

**Duration: unlimited**

**Job Type**: 80-100%

Work Location: On the road

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