Director QA, Immunology SE and Director QA, Internal Manufacturing

Do you want to bring quality assurance to the next level?

Do you want to make a true difference as a leader within quality assurance?

Then maybe we have the position for you:

On behalf of Sobi, H&P Search & Interim is now recruiting;

Director QA, Immunology SE and

Director QA, Internal Manufacturing 

About the two roles:

Sobi is a dynamic and growing company with a high pace of change. We are now looking for two positions as Director QA to join the Global Quality team. The positions will report to the Head of QA Immunology respectively Head of QA Haematology and be a member of the Quality leadership team for respective department.

The Director of QA Immunology SE will be responsible for quality operations including product release to market for Sobi´s MAH products.

The Director of QA Internal Manufacturing will be responsible for quality operations for internal manufactured products and release of manufactured Drug Substance.

Each role includes budget and personnel responsibility for approx. 10 QA Supplier Managers. The positions are based at the Sobi site, at Strandbergsgatan in central Stockholm.

Key Responsibilities:

  • Ensure products, processes, systems and procedures are in compliance with relevant authority requirements (FDA, EMA, ICH etc) and global Sobi procedures

  • Provide strategic and operational leadership for own team and Global Quality department including resource planning, budget responsibilities and HSE (Health, Safety, and Environment)

  • Responsible for QP release (upon included as QP in Manufacturing License) of products within area of responsibility and that delegate QPs are trained within own organization

  • Director QA Immunolgy SE: Responsible Person duties (upon included as RP in wholesale license) to ensure control of the distribution chain and maintain quality and integrity of Sobi products or partner products

  • Within own area, quality responsible for audits and continually monitoring performance

  • Host and responding incl follow-up on audits and Health Authority inspections, handling of recalls etc. within area of QA authority

  • Responsible for development and implementation of the quality strategies, goals and KPI’s within own area

Qualifications:

  • University degree (at least a M.Sc.) in chemistry, biology, pharmacy or a degree as civil engineer, as well as experience in research, development, manufacturing and distribution of pharmaceuticals > 10 years

  • Competence corresponding to Qualified Person (LVFS 2004:7) and Responsible Person (EC 2013/C 343/01)

  • Understanding and experience from biological drug development and sterile production

  • Understanding and experience from working with technical transfers of DS, DP and FG

  • Documented experience in GMP and GDP and knowledge of FDA and EMA regulations

  • 5-10 years’ experience from leadership and personnel management

  • Very good knowledge of English in speech and writing

  • Experience from other therapeutic areas, other formulations (e.g. tablets) and within the field of medical device is a merit

Personal attributes:

We are looking for an individual with pharmaceutical business understanding and experience from working with improving business practices/working procedures. You have great understanding of the pharmaceutical market interrelations and implications and experience from working with high impact stakeholders, e.g. authorities, strategic business partners.

As a person you possess strong management and leadership skills with the experience and ability to motivate and engage. You are an open-minded team-player with great communication and influencing skills and longtime experience from an international organization and working cross functional. Furthermore, you constantly manage and priorities workload effectively, both for the organisation as well as on a personal level. You are proactive, result-oriented and able to act in a fast-changing environment. You have excellent quantitative and analytical skills, taking on tasks with a systematic approach. You inspire others through your dedication and passion, and you create a culture of ownership and engagement.

About Sobi

At Sobi, we are transforming the lives of people affected by rare diseases. As a specialised international biopharmaceutical company, we provide sustainable access to innovative therapies in the areas of haematology, immunology and specialty care. We bring something rare to rare diseases – a belief in the strength of focus, the power of agility and the potential of the people we are dedicated to serving. The hard work and dedication of our approximately 1300 employees around the globe has been instrumental in our success across Europe, North America, the Middle East, Russia and North Africa, leading to total revenues of SEK 9.1 billion in 2018. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. You can find more information about Sobi at www.sobi.com.