Associate Iii

Vor 6 Tagen


Baar, Schweiz Biogen Vollzeit

**Job Description** About the role**

You provide expertise in Biogen’s Technical Product Complaint function as it pertains to product related customer complaints, ensuring compliance with regulatory standards for the markets in which the company's product are manufactured and distributed. Here you initiate and implement changes and improvements with support from management. You will report to the Manager, Product Complaints.

Location: as per our hybrid policy in Baar, Switzerland.

**What you'll do**

**1. Role in team
- Coordinator of complaints and sample handling**
- Processes incoming cases.

**2. Quality Management system processes**
- Initiates continuous improvement initiative/teams at a local or global level to address issues and resolutions with managerial support.
- Initiates/ support team efforts to simplify the processed to reduce errors and non -added value activities.

**3. Complaint data analysis**
- Performs metric reporting including those related to assigned CMOs, partners, supplier review meetings and audits.
- Communicate data trending, critical cases to impacted groups and manager.

**4. Internal and external stakeholder management**
- Participates in business relationships with internal departments as well as vendors and contractors.
- Deliver external training, develop training content with particular attention to market-specific needs with respect to contractors, Affiliates or Distributors.
- Delivers internal training, develop training content and manage updates for both global and local process requirements.
- Responsible for ensuring Quality/ performance of internal/ external stakeholders against procedures.

**5. Lab and sample investigation**
- Perform sample evaluation as per procedure.
- Support the creation of investigation method.
- Manage internal or external lab under management supervision and ensure processes comply to SOP/ GMP.

**6. Investigation, root cause and corrective/ preventive action**.
- Perform case investigation, monitoring correct CAPA follow up for established root cause.
- Manage sample returns and perform sample evaluation.
- Manage internal and external lab and compliance to established processes.
- Manage the investigation of high criticality cases aligning with relevant groups to identify root case and corrective action.

**Qualifications**
- Bachelor or Master in Life Science or Engineering or equivalent
- GMP knowledge
- Proficient in Word, Excel and Powerpoint.
- minimum 1 year relevant work experience
- Fluent English (written and spoken) is a must

**Additional Information**

**Why Biogen?**

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts