Senior Quality Assurance Manager

We are looking to recruit a Senior Quality Management Professional/Quality Assurance Manager. The location is at our newly established premises in Solna.

As Senior Quality Management Professional/Quality Assurance Manager you will join an innovative and growing company developing next generation biopharmaceuticals based on Affibody’s unique proprietary technology platforms: Affibody® molecules and Albumod.

Quality Management/Quality Assurance is a capability that Affibody currently is developing so the holder of this role will be a key player in building up and improving this function within the company. The role holds, together with the CEO, the responsibility for developing, continuously improving, and maintaining the company’s Quality System in alignment with the strategy and objectives and with the regulatory requirements (GxP).

The Quality System covers the whole value chain of the company’s portfolio, and relates to activities that are performed both internally and externally. The person we are looking for has the capacity to prioritize demands and produce high quality results across multiple cross-functional projects.

The role in general

The Senior Quality Management Professional/Quality Assurance Manager reports to the CEO and will develop, manage and continuously improve the Quality System according to the regulatory requirements and the company’s strategy. The role requires both operational and strategic thinking, and your main responsibilities include:

  • Responsible for further development and maintenance of the Quality Management System (QMS)
  • Ensure that all components of the QMS are kept current and that concerned documentation is adequate
  • Develop, implement and maintain a risk management system
  • Maintain up-to-date knowledge in FDA, EEA/EMA, ICH & country specific regulations as far as it applies to quality aspects
  • Oversee planning, implementation, maintenance, tracking and administration of the training program in accordance with the GxP requirements
  • Participate in sourcing of external partner(s) and responsible for respective quality agreements
  • Audit management – vendors and internal audits
  • Keep up to date within the area of Quality Management/Quality Assurance, including new regulations and guidelines

Experience and Qualifications

The right candidate fulfills the following qualifications:

  • Degree in Life Sciences
  • +10 years of quality assurance experience within the Biopharmaceutical industry, including a R&D environment
  • Experience of developing, implementing and managing QMS for development of biopharmaceuticals in a growing environment
  • Advanced knowledge and understanding of GMP and regulatory requirements and implementation with respect to quality practice
  • Experience of working within cross-functional teams
  • Experience of working with contract organizations and service providers
  • Experience of supplier and customer audits
  • Experience of market launch of biopharmaceuticals in different territories
  • Excellent skills in Swedish and English and ability to communicate in a business environment

Personal attributes

To be successful in the role you need to be comfortable working in a dynamic environment in a growing, partially virtual, R&D organization, and in cross-functional teams. You need to be a good communicator (verbal and written), both one to one, and in a larger group, and possess excellent team working skills to establish and maintain good collaboration with different parties.

You need to be motivated, committed, self-managed, flexible and have an open mind. You will also need to have the ability to focus on practical, commonsense and sensible approaches to find effective solutions with a focus on embedding continuous and improving quality- and compliance behaviors.

Process

In this recruitment we are collaborating with Haeger & Carlsson. Please apply through www.haegercarlsson.com. If you have any questions about the role, please contact Gunilla Haeger, +4670-461 93 87, gunilla@haegercarlsson.com or Martin Svensson, +4676-314 05 01, martin@haegercarlsson.com

Affibody in short

Affibody is a Swedish biotech company focused on developing next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.

Upcoming reports Financial calendar

  • Interim Report January to March 2020 (May 15, 2020)
  • Interim Report January to June 2020 (August 21, 2020)
  • Interim Report January to September 2020 (November 13, 2020)
  • Year End Report 2020 (February 2021)