QA Team Lead

QA Team Lead 100 % (f/m/d). Visp VS, CH

Bacthera is leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.

For our new site in Visp (VS) we are seeking a proactively, representative and strategic thinking:

QA Team Lead 100 % (f/m/d)

 The QA Team Lead will form a team of QA managers/specialists. He/she implements Quality Assurance capabilities that positively impact the quality strategy of the company. He/she will be accountable for the performance and results of the assigned area. As a QA Team Lead, he/she will be a member of QA Leadership Team.

YOUR PROFILE

  • Master degree or PhD in pharmacy, biotechnology, life science or related field.
  • More than 7 years of experience in the cGMP regulated pharmaceutical industry, preferably in a quality and compliance role in production.
  • Strong background in cGMPs is an asset.
  • Strong leadership skills; very good communication skills and interaction with all kind of interfaces within the organization, customers and with health authorities (Swissmedic, FDA etc.).
  • Strong team orientation.
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
  • Solution-oriented.
  • Sound experience in representing Quality and Compliance in the operational manufacturing environment.

ROLE AND RESPONSIBILITIES

  • Act as Responsible Person (FvP: Fachtechnisch verantwortliche Person) according to the Swiss legislation.
  • Manage all Quality and Compliance related activities.
  • Responsible that all manufacturing processes are executed on qualified equipment and validated processes.
  • Setting up/managing a team of QA managers/specialists. Provides leadership to the team with responsibility for all aspects of human resource management such as qualification, development, coaching and hiring,
  • Support the development of the overall quality strategy for Bacthera.
  • Partner with Operations to ensure alignment of Manufacturing and Support Functions in executing the strategy.
  • Act as SME for Quality/GMP compliance.
  • Trains and supervises staff and works cooperatively with Bacthera leadership to achieve quality and compliance goals.
  • He/she supports continuous improvements programs to establish an effective Quality Management System.
  • Ensure that primary responsibilities of QA are executed in line with corporate requirements, industry best practices and current regulatory requirements (cGMPs).
  • Responsible for resource planning of the assigned team members with regard to the fulfillment of all production orders.
  • Implements the Bacthera culture via openness for change and new ideas, cooperative teamwork and continuous improvement even outside his/her own area of responsibility. Implements a vision as important contributor to the organizations success.
  • Ensures a thorough information exchange from other management levels to his/her team and the other way around through regularly team meetings and escalation of production issues.
  • Ensures and manages the respective interfaces to the Manufacturing teams, QC, Support Functions, Project- and Site Engineering.

 You will be based in Visp, Switzerland. Are you interested to work for an innovative, dynamic and future oriented start-up company? Do you want to help us shape the future of Bacthera’ If yes, then send your full application to Ms. Sandra Gamboni, Head of Human Resources; saga@bacthera.com.