Director QA-RA

About Gyros Protein Technologies

Gyros Protein Technologies enables bioanalytical solutions and peptide synthesis that help scientists increase biomolecule performance and productivity in research, drug discovery, pre-clinical and clinical development, and bioprocess applications. Proprietary high-performance nanoliter-scale immunoassay platforms, Gyrolab® xPand and Gyrolab xPlore™, are used by scientists in leading pharmaceutical, biotech, CRO, and CMO companies for bioanalytical applications such as pharmacokinetics/pharmacodynamics, immunogenicity, and quantitating bioprocess-related impurities.

The centre of excellence for the immunoassay business of Gyros Protein Technologies is located in Uppsala. Since November 2019, Gyros Protein Technologies is the Biopharmaceutical Development Division of Mesa Laboratories Inc.

For more information, visit the company's websites at http://www.gyrosproteintechnologies.com and at http://www.mesalabs.com.

Hays Life Science is recruiting a Director for Quality Assurance and Regulatory Affairs to Gyros Protein Technologies in Uppsala. A great opportunity to have a high impact in the life science industry, and the opportunity to work with innovative technologies and a passionate team. The role is based in the Uppsala office, with a global responsibility for Quality Assurance and Regulatory Affairs.





Your new role

As a Director QA-RA, you will play a key role in the company, fully owning the QA and RA functions and responsibilities, such as e.g. the QMS system. The role has a global responsibility for Quality Assurance and Regulatory Affairs. Currently, there are no direct reports in the role, but operational leadership for US-based colleague is part of the responsibilities.

The majority of the role relates to Quality Assurance, while Regulatory Affairs is a new addition to the role. As overall QA representative, you will report on QA matters in executive management team meetings. With regard to Quality Assurance, you will be releasing products or delegating that authority.

Travel to the US is expected, but limited to a few times per year.



What you'll need to succeed

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Experience of working with, and in accordance with, ISO standards
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Experience of working with QMS systems (having implemented and/or owned such system(s))
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Audit experience (internal, external as well as client audits)
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Solid understanding of product development
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Extensive knowledge regarding handling of deviations and
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CAPA processes
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Understanding of Recall mechanisms and procedures
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English and Swedish - full professional proficiency, written and oral



You will find it important to have:

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Leadership experience, 5 years or more
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Skilled in writing and documenting
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Understanding for, and experience of, using KPI measures for follow-up



You will benefit from:

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Experience of having dealt with the FDA, directly or indirectly



As a person, you need to be:

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Grounded and composed
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Coaching leadership style
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Direct and clear communicator, yet flexible and perceptive
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Problem-solver
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Pedagogical, capable of training and educating others
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Moderately social - balances interaction well
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Focused on continuous improvement
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Skilled at leveraging the organization effectively



What you'll get in return

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The opportunity to work with innovative technology and a passionate team with nice and competent colleagues, with quick decision-making paths, and a company culture that is calm and with a high degree of freedom and opportunity to influence
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Personal development and growth opportunities. A company group with an explicit strategy to grow through acquisitions, which provide great development opportunities. Potential for extension of leadership responsibilities.
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A role with a lot of influence - you can truly make a difference
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Competitive salary and benefits package



What you need to do now

In this recruitment, Gyros Protein Technologies is partnering with Hays. If you are interested in the role, don't hesitate to submit your application today as applications will be processed as they come.
For specific questions on the role, please contact Linus Norrbom, linus.norrbom@hays.com.

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.