Quality Assurance Manager

Quality Assurance Manager

Main Purpose

Responsible for ensuring the robustness and effectiveness of the 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 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.

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