Sr. Director, Site Quality Head, Bern
Vor 4 Tagen
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**Senior Director, Head of Quality, Bern**
The Sr. Director, Head of Quality, Bern leads and manages all aspects of Quality (QA/QC) in support of the Janssen Bern site, and assures compliance with established cGMPs and Janssen Quality requirements. The role defines and implements the appropriate Quality standards for the Bern site and maintains a Quality Management System in compliance with all required regulatory standards and regulations, and Janssen standards, policies and procedures. The role develops and implements long-term strategies, executes the Quality program and ensures a reliable supply of high-quality products to both clinical research and commercial customers through the J&J Supply Chain. The role manages a team of people leaders and technical professionals within QA & QC based on assigned work, direction, coaching and developing capabilities.
**Main responsibilities**
**Site Quality Management**:
- Ensures an effective Quality Management System is in place to achieve Janssen Quality objectives and all regulatory requirements and ICH Q10.
- Provides direction to Quality Assurance and Quality Control to ensure the suitability and effectiveness of the QMS and GMP compliance.
- Determines adequate and appropriate resources to implement and maintain an effective Quality Management System.
- Leads, hosts and participates in Quality Management Review to monitor process performance, product quality and the QMS and advocates for continuous improvement of the quality system; ensures timely mitigation of any unfavourable trends.
- Ensures timely and effective communication and escalation regarding quality issues to the appropriate levels of management.
- Assures the required processes, procedures, systems and resources are in place to ensure a compliant manufacturing, testing and distribution process.
- Provides expertise and guidance in interpreting governmental/health authority regulations, agency guidelines and internal procedures to assure continued compliance.
- Hosts all Bern Health Authority inspections and acts as primary spokesperson for the site during inspections.
- Leads and hosts compliance audits including internal audits and regulatory inspections. Proactively develops and sustains strong relationships with regulatory Health Authorities.
- Analyzes regulatory authorities’ programs and activities in areas relevant to Bern products and advises site and Quality management of potential and actual actions that could adversely affect the business, represent quality exposures, or represent opportunities to be pursued.
- Maintain quality assurance programs and oversight to ensure that all released products are safe, effective and manufactured in compliance with regulatory requirements worldwide throughout their entire lifecycle.
- Defines departmental strategies for the Site Quality Organization, including Quality Assurance, Quality Systems and related support functions in alignment with the site strategy.
- Serves as process owner for Product Quality Review and Management Review processes; defines key performance indicators (KPIs) for the Quality organization to monitor and improve operational performance.
- Ensures the initial and continuing training of department personnel are carried out and adapted according to business needs.
- Authorizes written procedures and other documents, including amendments.
- Approves and monitors suppliers of materials, contract manufacturers and providers of other GMP-related outsourced activities.
**Delegation of Authority**:
- Acts as a deputy for the Qualified Person (Fachtechnisch verantwortliche Person) for Janssen Vaccines, Branch of Cilag International GmbH, according to the requirements of the “Bundesgesetz über Arzneimittel und Medizinprodukte” and the “Verordnung über die Bewilligungen im Arzneimittelbereich” and updated versions of these requirements as applicable.
- Decides on product release and rejection of non-conforming product independent from management, and has the decision authority on site for any product, quality and compliance related matters as a deputy for the Qualified Person (Fachtechnisch verantwortliche Person)
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