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Lead Quality improvement initiatives in innovative biopharmaceutical company.
As Director of Quality Assurance Operations at Orphazyme, you will be responsible for providing QA oversight and support of Orphazyme’s product disposition for clinical and commercial products manufactured at contract manufacturing organizations (CMOs) and tested at contract laboratory organizations (CLOs).
You will act as Qualified Person Delegate (QP Delegate) in accordance with EU GMP and manage other Qualified Persons (QPs) to provide final certification/release along with ensuring overall maintenance of company quality management system (QMS) to support release of product for the EU/EEA markets as well as wholesale distribution to the US market.
With direct report to Global Head of QA.
Your main tasks are:
Your qualifications are a minimum of 10-15 years of applied Quality industry experience. You have a minimum of 3-5 years’ experience acting and executing Qualified Person responsibilities and duties as defined in EU directive 2001/83/EC (as amended).
You have working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience with participating in successful regulatory inspections. You have experience with product disposition processes and requirements and cGMP manufacturing and testing within biotechnology industry. You have a proven track-record of success with implementing and maintaining quality systems and electronic systems in a pharma organization.
You have experience with working with CMOs, CLOs, and vendors, and relationship management is preferred. You have the ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment and you are agile and can effectively collaborate in a dynamic, cross-functional matrix environment.
You are a leader who is self-reflective and leads by example and drives the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement. You can navigate through ambiguity and rapid growth and adapt to change. Finally, you have a track-record of leading, coaching, and mentoring high-functioning and collaborative teams and you have the ability to constantly learn and challenge status quo.
You have a Bachelor’s degree in Pharmacy or other scientific disciplines.
You are a person with strong decision-making skills and work towards tight deadlines. You are a team player with experience with global matrixed organizational structure and posses a global mindset. You are confident and self-assured to enable courage in decisions, and you are a skilled and diplomatic communicator who identifies the necessary people to engage at each stage of the project. Moreover, you are highly motivated and interested in being challenged professionally and you have strong interpersonal skills and a proven ability to communicate with many stakeholders. Finally, you have a high level of organizational skills and attention to details.
Orphazyme offers a unique opportunity in a company with an exciting pipeline and a positive and informal environment. Orphazyme is growing rapidly and the rate of change is high and hence the opportunities to contribute and influence are many.
Travelling: 20 days per year.
Domicile: Ole Maaløes Vej 3, DK-2200 Copenhagen N, Denmark or Grafenauweg 8, Zug, CH-6300 Switzerland or 180 North Lasalle Street, Suite 3475, Chicago, Illinois 60601, USA.
For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Consultant Belinda Bramsnæs, Unique Human Capital on M: +45 28 44 28 44. All applications must be in English and are treated confidentially.