Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals on fulfilling the high medical needs of rare disease patients and providing treatment and services to them. Our employees have their background in various fields of research, industry and the academic sphere.
Together with PharmaRelations we are currently recruiting a Director of Quality and Qualified Person for our external manufacturing haemophilia.
Your new role
Sobi is a dynamic and growing company with a high pace of change. We are now looking for two positions as Director of Quality and Qualified Person to join our Quality Operations team. The position is within the Global Quality and Compliance organization and will report to the Head of Quality Operations.
Main areas of responsibility
Proactively handle Quality operations, ensure products are released and in compliance with current regulatory requirements and all quality contractual framework is in place and quality monitoring proactively in place. Fulfill requirements and responsibility for Qualified Person.
- Ensure products, processes, systems and procedures are in compliance with relevant authority requirements (FDA, EMA, ICH etc) and global Sobi procedures
- Lead the design, implementation and development of a proactive Quality organisation with competencies to ensure reliable delivery of competitive products in regulatory and GxP compliance within area of responsibility.
- Establishing and maintaining quality procedures within area of responsibility and ensure implementation in accordance with applicable laws, regulations and guidelines in compliance with Sobi global procedures and processes.
- Responsible for QP release of products within area of responsibility and that delegate QPs are trained within own organisation.
- Within own area, quality responsible for audits and continually monitoring performance
- Responding to and follow-up on Health Authority inspections, handling of recalls etc within area of QA authority
- Overall responsible for competent handling of Quality incidences within area of responsibility and proactively co-ordinate with other Sobi Quality organisations and stakeholders when relevant
- Ensure that Health Authority requirements and –trends with special focus within the areas of quality assurance/compliance are monitored and implemented
- Responsible for development and implementation of the quality strategies, goals and KPI’s within own area
- Responsible for managing the work of own group and ensuring team effort
- Responsible for SHE in own area
- Ensure budget adherence and maintain resource overview and plans.
- Facilitate cooperation with other functions in Sobi
Adding to position as Director of Quality and Qualified Person external manufacturing haemophilia:
Responsible for proactively handling of quality within area of QA authority and continuously safeguard quality and compliance (e.g. FDA and EU) in External Manufacturing and delivery of products so that Sobi will always fulfil official requirements for the manufacture of pharmaceutical products
- Responsible for compliant handling, trending and reporting for Marketing Authorisations held by Sobi
- Owner of quality agreements withs CMO’s
- Establish and maintain proactive QA oversight throughout CMO network related to External Manufacturing activities, hereunder identify, mitigate, manage and communicate risks
- Ensure and build competences for due diligence activities representing Quality and Compliance aspects with a clear perspective on Sobi business system.
Ensure technology transfer and knowledge transfer into efficient quality assurance and production
What you’ll need to succeed
- Minimum 10 years’ experience from pharmaceutical industry within quality, manufacturing, product development and/or regulatory affairs
- Experience from biological or sterile pharmaceutical manufacturing
- Minimum 5-10 years leadership experience
- Strong knowledge of GxP, FDA and EMEA regulations
- Pharmaceutical business understanding
- Experience from working with improving business practices/working procedures
- Understanding of the pharmaceutical market interrelations and implications
- Experienced in working with high impact stakeholders, e.g. authorities, strategic business partners.
- Experience from setting up and working with performance management, KPIs, including the management cycle
- Experience from working in an international organisation and across borders
Master’s degree in pharmacy or other relevant degree (Engineering, Chemistry or alike)
Fulfills requirement for Qualified Person (according to LVFS 2004:7)
Our values (CARE, Collaboration, Accountability, Respect, and Engagement) is the base for our daily work and your professional style should be:
- Strong in leadership and communication
- Proactive mindset and actions
- Strong interpersonal skills
- Good collaboration skills
- Result oriented
- Able to solve complex situations and problems
- Able to handle conflicts and create win-win situations
- Culture awareness and understanding the way of behaviour in different cultures
- Holistic business understanding
- Courage, empathy, trust, motivation
- Fluent in Swedish and English
- Proven written and verbal communication skills, both Swedish and English
What you need to do now
We look forward to receive your application. If you have any questions please contact Recruitment Consultants Eva Bremberg at 08-120 22 76 or firstname.lastname@example.org or Rikard Lundgren at 08-590 745 83 or email@example.com. Please apply through the apply button below.
Appointment of vacant positions at Sobi will take place with consideration of:
- Requirements of the role as it is currently framed as well as an assessment of how the post will develop;
- The competences, experience, personal qualities, and motivators of the candidates;
- The wish for Sobi to secure a well-functioning group with good team dynamics, able to be successful in an international, multi-cultural and cross-border business;
- A wish for all Sobi employees to embrace and align with the company’s CARE values in their day-to-day operations.
Sobi™ is an international specialty healthcare company dedicated to rare diseases. Our mission is to develop and deliver innovative therapies and services to improve the lives of patients. The product portfolio is primary focused on Haemophilia, Inflammation and Genetic diseases. We also market a portfolio of specialty and rare disease products across Europe, the Middle East, North Africa and Russia for partner companies.