For our client, a globally leading medical technology company, MintSearch is looking for a Senior Manager Quality Internal Audit, based at the EMEA Headquarters in Amsterdam.
The Senior Manager Quality Internal Audit is a challenging and exciting position for a professional and ambitious candidate who has experience in working in an international business environment, with a fast paced and dynamic atmosphere. You are able to work on your own initiative, set priorities, determined and have a positive can-do attitude.
RESPONSIBILITIES of the Senior Manager Quality Internal Audit
Working in partnership with the ONV Quality organisations audit group located at the manufacturing sites, you will:
- Be responsible for the strategic planning, and management of ONV quality audit program and post-processing of internal audit reports and data.
- Ensure that the audit programme for ONV sites is performed in effective and efficient manner.
- Ensure a dynamic audit process and program such that audits can focus on process and QMS, thus meeting compliance and product quality requirements.
- Ensure that the audit program is performed and addresses the requirements of 21CFR 820, ISO 13485, and other applicable standards to assess and ensure QSR compliance as it relates to manufacturing process and product specifications.
- Manage pre and post audit activities by involving all relevant stakeholders of different functions within ONV Quality teams.
- Identify and communicate to ONV Quality leadership issues that impact product quality, safety or efficacy, regulatory compliance or business continuity which have arisen from an audit.
- Provide RHQ Quality and Operations Management with periodical quality audit performance assessment and KPI’s of each manufacturing site.
- Provide SME input to enable risk to be assessed and as an input to the quality planning process.
QUALIFICATIONS / EXPERIENCE of the Senior Manager Quality Internal Audit
- Bachelor’s degree in Science, Engineering or related subject
- 8+ years relevant quality experience in GMP manufacturing environment in Medical Device/Pharma industry.
- Thorough knowledge of current regulations, pertinent regulatory guidance and industry trends.
- An understanding of the technical aspects of the areas being audited – understand the process, operational terminology etc.
- Experience in quality management systems is essential.
- Must possess strong communication, project management and leadership skills as well as have the ability to manage multiple projects simultaneously.
- Strong interpersonal skills and leadership skills.
- Strong written and oral communication and negotiations skills.
- Highly developed problem solving skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated knowledge of U.S. Food and Drug regulations, as well as of European and international regulatory/industry guidelines/standards, and ability to interpret and apply.
- Some travel required.
- Our client offers a competitive salary package (€ 80.000-€ 95.000 per annum)
- Car allowance, bonus and attractive secondary benefits
- Relocation package
We welcome your application with CV and motivation letter. You can send it to Manuela Willemsen-Lantos at MintSearch via email@example.com. For more information you can also contact us at +31(0)652055672.