Quality Compliance Manager (vervuld)

Vervuld

Functie omschrijving Quality Compliance Manager (vervuld)

The Compliance Manager will have the objective of maintaining high quality standards for the product manufacturing process and compliance with all applicable regulatory requirements. In addition this position is responsible for the absence of significant quality issues and regulatory compliance actions by government agencies.

This individual will lead and manage site audit readiness activities to ensure inspection readiness at all time, including:
• Prepare and host external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, J&J Corporate Audits for site. Responsible for effective regulatory agency inspections.
• Audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME’s, etc.).
• Assess the risk and applicability of audit observations from other J&J facilities to determine impact to the site
• Schedule and manage mock inspections as part of External Inspection Readiness activities.
• Provide timely information to support the inspection process, including those that maybe taking place at other sites / locations.
• Provide daily inspection communications regarding potential non-conformities.
• Prepare responses to external inspection or other regulatory notification associated with site.
• Ensure adequate corrective actions for external audit observations related to site, including investigations, monitor and drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure.
The Compliance Manager is responsible for the Internal Audit Program and Management Execution, including:
• Establish and execute an effective internal audit schedule for site. Conduct internal audits.
• Execute against established internal audit procedures.
• Ensure adequate corrective actions for internal audits, including investigations and corrective action plans, drive on-time completion of CAPA plans, perform follow-up with CAPA owners, and perform effectiveness monitoring and closure.
• Drive compliance and improvement in internal audit metrics.
• Ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements.
• Where appropriate, execute program(s) for training and evaluating qualifications of auditors.
The Compliance Manager is also responsible for monitoring the compliance profile of the site and driving proactive improvements, including:
• Support the creation and effective deployment of external regulations and standards, as well as internal J&J Quality System and/or Compliance standards.
• Assure that Quality & Compliance metrics are consistently and accurately captured for subsequent analysis and reporting. Drive compliance to Quality & Compliance metric targets.
• Create reports and communicate performance against metrics to key stakeholders. Highlight/communicate adverse trends in metrics, and take risk based action to remediate.
• Provide routine communication, updates and escalation to site and franchise.
• Organizational management regarding compliance trends and initiatives.
• Proactive identification and alerting of management of quality issues in time to resolve potential adverse effects to the customer, company image/reputation and/or the business.
• Provide input into Site Management Reviews. (e.g., internal audits.)
• Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.

Functie eisen Quality Compliance Manager (vervuld)

Candidate profile

A minimum of a Bachelor’s degree is required, preferably in Science or Engineering.
A minimum of 5 years of related experience in a Medical Device or other regulated industry is required with a minimum of 2 years management/supervisory experience. Experience coordinating compliance and/or quality system activities required.

Experience in Medical Device manufacturing or a related regulated field is required. The ability to interpret compliance regulations and requirements and effectively apply them to the implementation and/or enhancement of quality systems is required. Knowledge of medically regulated plant operations, processes and practices is preferred.

Knowledge of the following regulatory requirements is required: Quality System Regulations (QSRs), Good Manufacturing Practices (GMPs), 21CFR820, ISO 13485, Medical Device Directive (MDD), Canadian Medical Device Regulation (CMDR), Therapeutic Goods Administration (TGA) - Australia, National Health Surveillance Agency, (ANVISA) - Brazil, Ministry of Health, Labor and Welfare (MHLW) - Japan. Experience supporting external audits (such as FDA, Notified Body, or customer audits) is required.

Demonstrated knowledge or application of audit principles, concepts and practices related to a regulated quality system is required. The ability to complete regulatory reports and provide written correspondence to internal and external customers including regulatory bodies is required particularly in English. Knowledge of Microsoft Office (Word, Excel, Outlook, PowerPoint) is required. Experience, training, or certification in Process Excellence/Six Sigma tools and methodologies preferred. Certified Quality Auditor (e.g. Certified Quality Auditor (CQA), Certified Quality Technician (CQT), etc.) is preferred. Project management experience is preferred.

This role will require the ability to work autonomously and lead teams on specific compliance activities including projects and based business tasks, both planned and unplanned with accelerated timelines. Must be a critical thinker, detailed oriented with strong problem solving skills, able to oversee multiple tasks and effectively balance priorities. Must have excellent oral and written communication skills. Must have the ability to handle confidential data. The ability to collaborate effectively with employees of various disciplines and departments is required.

This position may require up to 20% international and domestic travel.

Bedrijfsprofiel

Our client:

Our client is a member of Johnson & Johnson's Family of Companies is located in Leiden, the Netherlands.
The company is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.
On behalf of our client we are currently recruiting for a Quality Compliance Manager.

Arbeidsvoorwaarden

As an employee our client considers you as our most valuable asset. Your career is taken seriously. As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, our client ensures your personal growth.
Our client cares for you and your family now and in the future.

Locatie

Leiden

Contactpersoon

Tjen Schifferstein

Contactpersoon van deze vacature