Director, Quality Assurance

The Director, Quality Assurance is 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 the vendor qualification and monitoring program.
• Coordinates and hosts client audits.
• Advises Senior Management and operations regarding regulatory and corporate compliance and suggest 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 and provides 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.
• Sole responsible 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 on GCP, GxP

Required Skills

• Proven quality/regulatory ability and experience.
• Prove leadership/supervisory experience
• Ability to adhere to established timelines, processes and procedures.
• Excellent attention to details.
• 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 and well 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.