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Vice President Quality Assurance

  • Externa annonser
  • Remote Lund
  • 2024-11-03

Hemsida Hansa Biopharma

Fullständig jobbeskrivning

Would you like to be part of a global biopharma company?
Hansa Biopharma is a global, commercial-stage biopharmaceutical company, pioneering the development and commercialization of innovative, lifesaving and life altering treatments for patients with rare immunological conditions.

Our broad therapeutic pipeline based on the company’s proprietary IgG-cleaving enzyme technology platform has potential to address serious unmet medical needs in autoimmune diseases, gene therapy, and transplantation.

By empowering our people and working in an agile way we move our projects forward with high speed, efficiency, and scientific excellence. We strive to attract leading talent from around the world, broaden our network of partners and establish a presence in key markets around the world. There are many opportunities for highly qualified, motivated, and passionate team players to join us on our exciting journey.

Hansa Biopharma was founded in 2007, with the corporate headquarters in Lund, Sweden and has operations in other European countries and in the US. The Company has been listed on the Nasdaq First North Growth Market Stockholm from 2007 to 2015 and on the Nasdaq Stockholm since 2015.

Position: Vice President Quality Assurance
The Vice President of Quality Assurance (VP QA) is responsible for leadership and direction of all aspects of the Quality Assurance function, to ensure appropriate level of compliance of the company’s clinical development activities and partly outsourced activities for GMP, GDP, GLP, GCP and GVP with recognized regulations and guidelines.

The VP QA position includes managerial and leadership responsibilities for the QA team, currently consisting of five QA professionals with varying degrees of experience and GxP expertise. This role reports to the CEO and regularly reports quality and compliance status, activities and strategies to the Executive Committee.

Principal Responsibilities

  • Lead, manage and mentor a team of QA professionals with varying degrees of experience and GxP expertise
  • Provide Quality Assurance input and support to help the achievement of the Company’s strategic and other business goals in the form of schedules, quality plans, and budgets
  • Maintain and develop the Hansa Quality Management System to support clinical studies, future product registration and post marketing activities.
  • Provide GxP Quality Assurance oversight of all external vendors’ quality programs, including CROs, central labs, investigator sites, CMOs, and other key partners supporting clinical and commercial programs
  • Responsibility for ensuring compliance across Hansa organisation, including writing, reviewing, and approving quality documents, e.g. SOPs, change controls, deviations, product complaints etc.
  • Develop, execute and maintain appropriate training programs throughout Hansa to meet GxP and ICH requirements

In order to succeed in this position, we believe that you should possess:

1. Master’s degree or a PhD with focus in Pharmaceuticals, Engineering, Life sciences, or another similar technical field

2. Extensive work experience in Pharmaceutical/ Biotech/Biopharma industry

3. Demonstrated experience within QA e.g:

  • solid Quality Management and Compliance record on a global level in the pharmaceutical industry
  • experience with EU and FDA inspections, inspection readiness and follow up
  • experience with gap analysis and risk management
  • strong and demonstrable knowledge of international GxP regulations and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment
  • experience with oversight of outsourced activities
  • extensive experience with regulatory compliance and aligning GCP, GVP, GLP GMP and GDP activities across various internal organisational functions, global affiliates and vendors
  • experience with validation/qualification of computerized system from a QA perspective

4. Documented management experience:

  • successfully participated in management teams & executive boards
  • evidence of being an impactful, and involved
  • demonstrated ability to engage in cross functional interactions, having good collaboration and social skills with different types of subject matter experts and multi-cultural stakeholders.

5. Outstanding written and verbal skills in English

You as a person
As colleagues, we genuinely care about each other. We are friends, empowering one another and appreciating everyone’s unique traits and contributions, and we believe in working together as a team. To foster the best possible organisational match in this role, we hope that you recognise yourself as having the following characteristics:

  • A self-motivated team player with a “can do attitude”, and a sincere desire to continuously develop as a leader
  • Service minded by demonstrating the ability to listen to and understand others and help to find smooth and constructive solutions
  • Excellent communication skills, applying a pedagogical approach, mastering the ability to collaborate with and present to individuals of varying levels of authority, including senior and Executive leadership
  • Leadership skills, demonstrating empathy, personal maturity and creating a supportive environment
  • Social skills with the ability to build trusting relationships, engage in cross functional interactions with different types of subject matter experts and multi-cultural stakeholders
  • Ability to independently solve problems and work with multi-disciplinary project teams.

Personal skills are valued highly and will be given great consideration in the recruitment process.

Our culture and behaviours
Working at Hansa is more than a job for us, and our culture is characterised by pride. Pride in what we do, in the company and in what we have, and will, accomplish for patients around the world. Our culture is supported and enhanced by our behaviours, and above and beyond professional qualifications and experience, we look for the following behaviours in all our future colleagues:

Self-motivated
Doer
Team player

Our people mean everything to us, and so our leaders, in addition to the above, must also be able to evidence the behaviours below:

Brave
Empathetic
Lead-by-example

All these behaviours will be assessed at various stages of the recruitment process.

Hansa is for everyone
At Hansa we aspire to be a truly great place to work. We know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the countries and communities in which we operate and ultimately the patients we exist to serve. Our recruitment policy is simple – hire the best person for the job.

Type of employment
This is a permanent and full-time (40 hours) position.

Hansa Biopharma is based in Lund, Sweden. There is a flexibility to work from home a couple of days per week when possible.

The process
Please apply for the position through the following link. Applications should not be sent through any other platform.

Attach your CV and a cover letter in English only. Unfortunately, we are unable to review applications made in other languages.

The last day for applications is Monday 19 August 2024. We will review applications as they are received and are planning to hold interviews starting w/b 19 August.

For questions regarding the position and process, please contact HR Business Partner, Anna Lindberg, [email protected].

We look forward to receiving your application – join us and make significant contributions to Hansa Biopharma´s research!

Please note: No external recruitment support is required. Only applications received directly will be considered.

  • Externa annonser
  • Remote Lund
  • 2024-11-03

Hemsida Hansa Biopharma

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