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Director of Quality Systems & Compliance

Become responsible for implementing world class quality system processes and operations in innovative biopharmaceutical company.

 

As Director of Quality Systems & Compliance at Orphazyme, you will be responsible for implementing world class quality system processes and operations to ensure that Orphazyme exceeds the highest level of compliance while monitoring the health of the Quality Management System (QMS) for continuous improvement.

You will assist with building a culture of quality and provide strong leadership and strategic direction of Orphazyme’s QMS to support contract testing and manufacturing clinical and commercial products. You will oversee supplier quality audits, third party and health authority inspections, internal audit program, customer complaint program, document control, records management and training for Orphazyme.

With direct report to Global Head of QA.

Your main tasks are:

  • Implement Orphazyme’s overall QMS and quality manual, policies and procedures and ensure continuous improvement while keeping it current with emerging and changing international regulations, guidance documents and current industry best practices and expectations
  • Provide cross-functional quality leadership and act as a GXP compliance subject matter expert on technical matters involving product examination, testing and disposition, quality investigations, validation, data integrity, and in business matters involving facility and laboratory operations
  • Evaluate business goals, identify improvement opportunities and apply scientific methods, statistics and problem-solving techniques to improve and sustain product quality and process effectiveness in the overall QMS lifecycle
  • Oversee the performance of Orphazyme’s QMS by leading Management review meetings and monitor the state of control and overall quality of Orphazyme’s drug substances and drug products
  • Manage the performance and effectiveness of the quality system programs such as risk management, change management, discrepancy and CAPA management, training, documentation and records management, and data integrity
  • Manage the internal audit and supplier audit programs and third party/regulatory inspection programs for the international organization
  • Provide QA support and manage overall customer complaint program for Orphazyme’s clinical and commercial products and international operations

Your qualifications are 10-15 years of Quality industry experience. You have working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience with hosting and facilitating successful regulatory inspections. You have experience with computerized systems, automation, operations and manufacturing and testing within the biotechnology industry.

Moreover, you have a proven track-record of successful implementing and maintaining quality systems and electronic systems in a pharma organization.

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 are able to  navigate through ambiguity and rapid growth and adapt to change. You have a track record of leading, coaching, and mentoring high-functioning and collaborative teams and 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.

Unique Human Capital A/S
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cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
Vi er over 200 mennesker, der arbejder med viden, kreativitet og teknologi
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