Quality Assurance Manager

Within the QbD group, we are looking for a Quality Assurance Manager who can be assigned to clinical activities.
Functieomschrijving
Main Purpose

Responsible for ensuring the robustness and effectiveness of our Quality Management System (QMS) governing the clinical research activities. This includes:

  • Assuring all systems, processes and their outcomes comply with applicable international and national regulations and guidelines and fulfill clients requirements.
  • Executing internal and vendor audits, participating in client and regulatory inspections, and/or managing the administration and reporting aspects of quality management systems.
  • Serving as quality consultant to the organization, acting as a resource for training activities and policy-making decisions, supporting business leaders in mitigation of risk, and responsible to build relationships between on-site QA services and QA management of designated clients.

Main Responsibilities

· Quality Initiatives:

  • Support the Director Training and QA in establishing a clearly defined QMS that is robust and effective in ensuring regulatory compliance.
  • In collaboration with operational departments, support the development of written procedures (SOPs) that ensure compliance with applicable regulatory requirements and industry standards.
  • Investigate and report on deviations. Ensure effective root cause analysis is performed and adequate CAPA plans are defined and implemented in a timely manner.
  • Identify process improvements opportunities and foster a culture of quality.
  • Lead internal quality focused meetings and/or projects.
  • Can be assigned as QA consultant on client QA projects depending on the required technical expertise and experience.
  • Stay up to date with current trends, knowledge and development and proactively identify opportunities to update and increase knowledge and share with others.
  • Maintain and build a professional network.
  • Attend meetings and conferences, as required.

· Advice & Expertise:

  • Develop training materials and/or deliver training related to quality matters, as assigned, and in collaboration with the Director Training and QA.
  • Provide guidance and support to project teams on the pragmatic interpretation of GxP, SOPs, quality and regulatory requirements.
  • Help develop and maintain quality management related metrics to help us understand how it is performing with respect to quality.

· Auditing:

  • Support the Director Training and QA managing the internal QA audit program.
  • Plan and conduct programmed and contracted audits.
  • Ensure audit reports meet internal/external quality standards and timelines.
  • Support our employees in the follow-up of audit findings and implementation of agreed CAPA plans.
  • Liaise with sponsor auditors and regulatory inspectors on the follow-up of findings and the implementation of agreed CAPA plans.
  • Support the Director Training and QA in the evaluation and trending of audit and inspection findings.

Profiel

Education

Master’s degree in (para-) medical sciences or equivalent by experience.

Experience

  • Minimum 5 to 10 years clinical research experience in a pharmaceutical company, CRO or regulatory body and at least 5 years’ experience in Quality Management;
  • Minimum of 2 years’ auditing experience in GCP.
  • Detailed knowledge of ICH GCP E6 R2, EMA directives 2001/20/EC + Device directive, EMA regulations (device and clinical trials), FDA regulations FDA CFR part 11, 50, 54, 56, 312, 820 and ISO 14155;
  • Proficient in Microsoft Office (Outlook, Word, Excel, and Power Point);
  • Being very knowledgeable about all aspects and phases of clinical research.

Skills and Competences

  • Demonstrate sense of responsibility, integrity, diplomacy and confidentiality.
  • Ability to be flexible and to adapt and work effectively with a variety of situations or individuals.
  • Gives advice, acts as a consultant for complex projects, leads, manages and directs others.
  • Very strong interpersonal skills and the ability to build relationships with stakeholders, including staff, Management Team and external partners;
  • Demonstrated ability to effectively and persuasively communicate verbally and in writing.;
  • Demonstrated proactive approaches to problem-solving with strong decision-making capability;
  • Emotional maturity;
  • Highly resourceful team-player, with the ability to also be extremely effective independently;
  • Sensitive to cultural differences.
  • Fluent in Dutch, French and English.

CONTACT for more information:
Liesbeth Peeters
jobs [at] qbd [dot] eu
03 844 45 01

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