GPS​ ​Quality​ ​Manager 50% (ro-137)

Status: 
paused
Location: 
4070 Basel
Start Date: 
2018-01-01
End Date: 
2018-12-31
Deadline: 
2017-11-14 10:30
Hours per day: 
4,00
Hours per week: 
20,00
Workload: 
50%
Total Hours: 
1.044
Assignment: 

Background

For our Swiss customer located in Basel we are currently looking for (m/f) a GPS​ ​Quality​ ​Manager 50%

Type of placement: 1 year, external contract with possible long term extension
Company: major Pharma company in Basel area
Salary: level 1-2, please ask us for the exact rate range

(monthly gross salary levels in CHF, level1= 5-10k , level2=10-15k, level3= >15k) 

 

Objectives​ ​and​ ​Scope​ ​of​ ​Position

  • To provide Global Product Strategy (GPS) staff with compliance support to ensure that GPS regulated activities are conducted in accordance to the applicable SOPs, guidelines, policies and relevant Health Authority regulations
  • To provide Quality Management support ensuring that regulated GPS activities are executed efficiently, effectively and in compliance
  • To support the sharing of ‘best practice’ learnings within GPS

 

Summary​ ​of​ ​Main​ ​Responsibilities

 

1. Quality Management

  • Implement Quality Management processes to improve the accuracy and timelines of its output, and to meet established standards (e.g. compliance checks)
  • Develop and maintain GPS quality standards & metrics for key GPS activities
  • Active review of audit reports, propose and monitor action plans (CAPAs), monitor and manage Market Research and Patient Support programs deviations
  • Lead and coordinate supplier quality assessment for regulated processes in GPS
  • Identify opportunities for improvement for GPS regulated processes
  • Audit/Inspection Readiness support for GPS
  • Manage multiple stakeholders interacting with Global Product Strategy on regulated processes 

2. Compliance Management

  • Execute and oversee processes contributing to Safety Regulatory Documents (Periodic Benefit Risk Evaluation Report, Product Risk Management Plans, Development Safety Update Report etc)
  • Play an active role in the preparation and review of Controlled Documents & processes/working guidelines
  • Work proactively as a member of global and regional Compliance & Training networks to maintain and improve consistency across the organization, and sharing of best practices

3. Compliance

  • Is responsible for acting in line with legal, regulatory and company standards and codes of practice (e.g.  Code of Conduct, applicable Roche directives, guidelines and SOPs)
  • Completes all required training modules as a priority
Requirements: 

Professional​ ​and​ ​Technical​ ​Requirements:

  • University degree preferably in life sciences/biology/medicine or other healthcare discipline
  • Certification in Pharmacovigilance education

Professional​ ​Experience​ ​Required

  •  Must​ ​Have​: At least 6 years professional experience in pharmacovigilance, compliance/quality related function in pharmaceutical industry at a local, regional or global level
  • Must​ ​Have​: In-depth knowledge of GVP, Healthcare & Medical compliance, SOPs and regulatory requirements
  • Must​ ​have​: Demonstrated professional experience of at least 3 years in a global organization on improving processes in a regulated environment delivering concrete efficiency gains and simplification
  • Must​ ​Have​: Fluency in written and verbal English language
  • Based on the region close to Basel
  • Master office suite tools (Microsoft, Google Suite)
  • Knowledge on controlled document environments (Touchpoint, Condor etc)
  • Experience in Quality Risk Management or Quality Management is an advantage
  • Strong analytical and decision making skills in a complex, fast paced, and changing environment
  • Experience of resolving complex issues in a matrix organization
Prefered Interview Dates (YYYY-MM-DD): 
2017-11-16