LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world.
We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.
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.
Join our team and discover how your work can impact patients' lives around the world!
Some of the Perks our LabConnectors Love:
- We truly live our values: People First, Quality Focused, Customer Centered, Technology Driven and Accountability Always
- The opportunity to make a meaningful impact on a passionate and growing team
- Strong communication and collaboration within a smaller sized team
- Access to tools and resources that empower you to excel in your role
In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication.
We are proud to be an Equal Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic.
LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with the General Data Protection Regulation (GDPR). For this job posting, all hiring decisions are made with meaningful human involvement and consideration. In this context, no applicant is subject to a decision based solely on automated processing within the meaning of Article 22 of the GDPR.
To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/
If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect - please email [email protected] or call +1 (423) 722-3155.
Skills Required
- Bachelor’s or master’s degree
- Four to six years of experience as a Quality Assurance leader or relevant experience
- Proven quality and regulatory experience
- Leadership or supervisory experience
- Strong planning, problem-solving, organizational, and time-management skills
- Proficiency in Microsoft Word, Microsoft Excel, and database software
- Fluency in German and English
- Experience in clinical trials and a clinical laboratory environment with GCP or GxP focus
- Third European language
- Research Quality Association Cert-GCP or Cert-GCLP certification, or European Society for Quality Certified Quality Auditor certification
What We Do
LabConnect is a global central laboratory and clinical-trial solutions partner. It provides routine and esoteric laboratory testing, clinical-trial kit building, sample management and tracking, biostorage, scientific support, consulting, data management, and embedded resourcing. The company serves pharmaceutical and biotechnology companies, clinical research organizations, and other sponsors, helping accelerate medicine development by integrating sample-related activities across the study lifecycle from planning through execution.
