QA Manager

QA Manager 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, goal-oriented and experienced:

QA Manager 100 %(f/m/d)

 The QA Manager, as a member of the QA Unit, be involved in the commissioning, qualification and process validation of a new manufacturing facility and in the establishment of the quality management system and process, thus ensuring Quality oversight and compliance with national/international requirements and cGMP standards.

YOUR PROFILE

  • Bachelor degree, Master degree or PhD in biotechnology, pharmacy, life science or related field.
  • More than 5 years of experience in the cGMP regulated pharmaceutical industry, preferably in a quality and compliance role in production and CAPEX projects.
  • Strong background cGMP regulations.
  • Expertise in CSV beneficial.
  • 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.
  • Experienced in representing Quality and Compliance in the operational manufacturing environment.
  • General knowledge of manufacturing processes and analytical methods.
  • Auditing and audit hosting experience.
  • Experienced in the interaction with health authorities (Swissmedic, FDA, EMA etc.).
  • Ability to oversee project execution to identify non-compliance from quality standards.
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment.

 ROLE AND RESPONSIBILITIES

  • Is involved in all quality related activities for the manufacturing processes.
  • Responsible for review and approval of documents such as Standard Operating Procedures, Master Manufacturing Batch Records, Deviations Reports, Change Requests, Qualification/Validation Protocols and Reports etc.
  • Ensures all manufacturing related deviations are appropriately investigated and recorded.
  • Directs the investigations of customer product complaints and assures the timely completion of the appropriate documentation.
  • Is responsible to drive CAPA and effectiveness check items to completion and timely closing.
  • Releases or rejects Drug Substance and Drug Product batches on behalf of the Responsible Person.
  • Evaluates product-related changes, assesses relevance to regulatory filings, provides change notifications for endorsement to customers where required and approves the change requests.
  • Ensures an efficient cGMP compliant life cycle management of all products manufactured.
  • Represents QA in project/tech transfer teams for new manufacturing processes.
  • Supports and approves project/product specific risk assessments.
  • Is involved and supports internal and external audits (incl. inspections by health authorities).
  • Has the authority to make quality decisions for the respective projects in internal and external meetings.
  • Identifies emerging QA relevant topics, communicates to the organization and works actively on their development into new or already established Quality and Compliance strategies and/or standards.
  • Supports cGMP training programs to ensure staff is being trained.
  • Trains and mentors junior employees to better accomplish and perform in their duties as quality professionals.
  • Actively supports the Quality culture as a role model.

 

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.