Global Quality Systems Manager (m/f/x)

Wörwag Pharma – a medium-sized, internationally active, family-owned pharmaceutical company headquartered in Böblingen near Stuttgart, Germany, which recognized and scientifically proved the importance of biofactors very early on. For more than 50 years, we have been fighting the civilization diseases of our time - preventive, accompanying, healing. Our slogan "Getting closer helping better" is not just a promise to doctors, pharmacists and patients. It is an expression of our colorful corporate culture and our collegial cooperation among our now 1,200 employees worldwide.

Become a part of our team in our headquarter in Böblingen (near Stuttgart) because we are looking for you as a

These tasks await you

• Function as Sub-Team-Lead for the "Deviation and Complaint (DAC)" Subteam with the Global Quality Systems Department, which includes:
  • Functionally coordinating two other Quality Experts within the subteam and organizing their work and priorities
  • Operationally working on and leading the investigation and successful closure of all deviations including OOX events either detected in the headquarter or at our manufacturing sites, legal entities or contract-manufacturing organizations (CMOS) as well as serialization alerts and product-technical complaints received from the market
  • Initiation of adequate corrective/preventive measures (CAPAs) and performing respective effectiveness checks
  • Leading an initiative to reduce any backlog on legacy CAPAs
  • Creating presentations of cases of high significance (e.g. when batch release is impacted or risk to recall imminent) for respective steering bodies (such as product alarm or supply chain committees)
• Function as Primary Process Owner or Deputy thereof for the Processes Deviation, Complaint, Out-of-Specification/Trend Events (OOS/OOT), Serialization Alarm, Root Cause Investigation and CAPA Management, which includes:
  • Authorship or Co-Authorship of the applicable Global SOPs, Working Instructions and Forms
  • Representing these processes in audits and inspections of the Headquarter and associated legal entities
  • Business Ownership of the Quality Event (QE) Module of the electronic Quality Management System (eQMS)
  • Organizing any training required for these processes and the QE system
  • Continuously improving these processes, especially by enhancing efficiency and effectiveness, but also by augmenting them with artificial intelligence
  • Reporting all Key Performance Indicators (KPIs) of these processes as well as their trend assessments in the Quality Management Review
  • Team Member of the Project rolling out the eQMS QE Module to other sites and affiliates
  • Evaluating any IT changes to the eQMS QE module and supporting the creation of respective functional risk assessments or associated system validation tasks
• Support the Head of Global Quality Systems in all activities improving the group quality control capabilities and efficiencies, e.g. by realizing a concept to establish a Center of Analytics Excellence at one of our Manufacturing hubs

What you bring with you

• Advanced Degree (e.g. BSc, MSc, Diploma, State Exam) in a field of natural science (e.g. biology, chemistry, biomedicine, pharmacy, bio/pharma-engineering)
• Prior working experience in Quality Control and/or Quality Assurance of a life science (pharma, consumer goods, medical device, food or biotech) company, most optimally in a senior expert or project leader position
• Strong experience with at least 3 of the following criteria:
  • Root cause analysis techniques and investigation methodologies
  • Risk Assessment methodology such as FMEA
  • Handling records in an electronic Quality Management System
  • Working with a Laboratory Information Management System (LIMS), e.g. based on SAP
  • Deep understanding of pharmaceutical manufacturing and analytical/QC processes

We offer you

• A dynamic, international environment with the opportunity to take on responsibility quickly and extensively, to contribute experience and knowledge and to implement ideas
• Varied challenges, as well as exciting projects with a strong team spirit
• Compensation in line with the market and your performance, as well as additional benefits which can be used flexibly according to your needs, e.g.,   
  • Subsidy for direct insurance
  • Individual compensation options for days off, pension provisions or payout
  • Bonago vouchers for special occasions
  • Support for your general well-being and/or work-life balance
  • Health-promoting measures such as discounted conditions on over-the-counter (OTC) pharmacy products or health days
• Flexible trust working hours as well as the possibility to work mobile up to 75% of your working time 
• Central company headquarters with free parking facilities, good public transport connections as well as mobility allowances
• A wide range of opportunities for personal and professional development
• Regular employee events

We are looking forward to receiving your application!