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Director of Quality Assurance Operations

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:

  • Execute QP delegate responsibilities, duties, batch certification and disposition for products in the EU as defined in EU Council Directives and Eudralex Volume 4, Annex 16 (market release as technical release is done at CMOs)
  • Manage QPs and review and approve disposition documentation to certify compliance with cGMP and international regulatory requirements and internal policies, procedures and specifications
  • Approve certificates of analysis and certificates of compliance in support of product disposition
  • Manage overall disposition process to ensure on time disposition per approved and defined turn-around times to meet supply and customer requirements and timelines
  • Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, and change controls)
  • Review batch records, testing records and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met and are conducted in accordance with regulatory filings, regulatory requirements and internal policies and procedures
  • Review and approve method, equipment and process validation protocols and reports to ensure compliance with approved acceptance criteria
  • Collaborate with manufacturing and testing contract facility personnel and internal subject matter experts in CMOs, contract research and clinical sites, QA Systems and Compliance, QA Disposition, Supply Chain to support ongoing operational activities and resolve equipment, testing, and process issues in support of product disposition activities
  • Facilitate and coordinate disposition of product for applicable regions and markets with Regulatory Affairs, QPs and Supply Chain
  • Manage activities within approved budget and communicate budget, project requirements and issues to Quality Management

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.

Unique Human Capital A/S
/ /
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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