Director, Quality Assurance

TheDirector, Quality Assuranceis responsible for quality operations and regulatory compliance; works through others to achieve organizational quality and compliance goals and works closely together with the international Quality and Regulatory Services department.   

Please note: this role is best suited for candidates local to Cologne.The role is intended to be primarily onsite, with the expectation of working from the office most days. To support work-life balance, we offer flexibility for up to two remote workdays per week, subject to business needs and manager approval.

Essential Duties and Responsibilities  

• Advises & directs EMEA Operations, Quality and Regulatory Services, EMEA Management Team and others on quality matters and regulatory requirements.  
• Provides oversight of quality assurance and quality control activities.  
• Performs vendor audits and provides oversight of thevendor qualification and monitoring program.  
• Coordinates and hosts client audits. 
• Advises Senior Management and operationsregarding regulatory and corporate compliance andsuggest potential avenues for compliance. 
• Creates an annual strategic EMEA Quality Plan.  
• Provides regulatory and compliance risk reviews of contractual negotiations. 
• Provides regulatory guidance to QA and IT staff surrounding configurable systems validation. 
• Provides clear and concise communication of audit outcomes and management review reporting for regulatory and quality consulting advisements. 
• Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating,conducting and documenting gap analyses. 
• Participates in andprovides quality guidance for strategic planning sessions. 
• Interprets quality philosophy to key personnel in EMEA organization. 
• Maintains and expands regulatory knowledge,in particular to the ICH Principles of GCP, General Data Privacy Regulation and International GCPs; provides industry leading compliance guidance and quality assurance consultation to internal and external stakeholders. 
• Soleresponsible for the Document retention and Record management for all regulated documents per ICH E6 R2 in EMEA facilities
• Responsible Person as described in 2013/C 343/01 on Good Distribution Practice of medicinal products for human use. 

Education/Experience 

• Bachelors or Master’s Degree with four to six years of experience as a Quality Assurance leader or relevant experience.  
• Strongly Preferred: Experience in Clinical Trials and a Clinical Laboratory Environment with a focus onGCP,GxP

Required Skills 

• Proven quality/regulatory ability and experience.  
• Prove leadership/supervisory experience 
• Ability to adhere toestablished timelines,processes and procedures.  
• Excellent attention todetails. 
• Strong planning and problem-solving skills. 
• Self-motivation and ability to work well independently, as well as using a collaborative team approach.  
• Ability to adapt to changing environments and requirements.  
• Ability to make quick andwell thought-out decisions.  
• Excellent organization and time management skills, communication, multitasking, interpersonal and listening skills.  
• Strong public speaking skills. 
• Demonstrated business acumen.  
• Proficient in Microsoft Word, Excel, and database software.
• Fluent in German and English, third European Language is a plus. 

Certificates and Licenses 

• Research Quality Association Cert-GCP or Cert-GCLP certified or European Society for Quality (EOQ) Certified Quality Auditor preferred.