Quality Assurance Manager

LabConnect

Posted on: August 5, 2022

Closing: September 04, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

We're searching for an experienced Quality Assurance Manager who can confidently achieve organizational quality and compliance goals and oversees the Quality and Regulatory Services department for our global central laboratory services client.

Are you looking to make a meaningful impact in your career? This is an exciting opportunity to work for a growing, ethically conscious organization that is revolutionizing central laboratory services for complex trial support.

Work for an organization that truly invests in its people. 

The perfect candidate is a proven practical problem solver who can confidently investigate issues and draw logical conclusions, understand various technical instructions, and mathematical and diagrammatic data representations in both an abstract and concrete manner.

Essential Duties and Other Responsibilities 

  • Advise Operations, Quality and Regulatory Services, EU Management Team and others on quality matters and regulatory requirements.
  • Provide oversight of quality assurance and quality control activities.
  • Perform vendor audits.
  • Provide oversight for the vendor qualification and monitoring program.
  • Coordinate and host client audits.
  • Advise Senior Management and operations regarding regulatory and corporate compliance.
  • Provide 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.
  • Assist Management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting Gap analyses.
  • Participate in and provide quality guidance for strategic planning sessions.
  • Maintain and expands regulatory knowledge, in particular to the ICH Principles of GCP, General Data Privacy Regulation and International GCPs.
  • Provide industry-leading compliance guidance and quality assurance consultation to internal and external stakeholders.

Your Education/Experience

  • Bachelors or Master's Degree; four to six years of relevant experience.
  • Strongly preferred: Experience in Clinical Trials and a Clinical Laboratory Environment focusing on GCP, GxP.
  • Research Quality Association Cert-GCP or Cert-GCLP certified or European Society for Quality (EOQ) Certified Quality Auditor preferred.
  • Fluent in German and English, a third European language is a plus

Required Skills

  • Proven Quality/Regulatory ability and experience.
  • Ability to adhere to established timelines, processes, and procedures.
  • Excellent attention to detail.
  • 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.
  • Public speaking skills.
  • Proficient in Microsoft Word, Excel, and database software.

LabConnect

Posted on: August 5, 2022

Closing: September 04, 2022

Salary($): Undisclosed

Position Type: Full Time

Career Focus: Clinical Trials, Quality

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