Site Quality Head Xian
Synthes GmbH
Date de publication :
18 octobre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Zuchwil
Essential Job Duties and Responsibilities
Leads and manages the Quality organisation (Quality assurance and Quality Control), all Quality related programs and activities to support the site, the manufacturing and testing operations at Xian. Functions and activities include Quality review and approval functions, Compliance activities, Product Testing and Release activities, etc.
Ensure business, quality and compliance goals are met in full compliance with all J&J, IMSC and government-issued environmental, health, safety, quality and regulatory policies and guidelines.
Principal Responsibilities
- Overall Quality accountable for the Xian site in China. Provides overall leadership and direction to the quality organization, building processes to improve the capabilities of the organization.
- Assures appropriate processes and resources are in place and effective to deliver a sound compliance profile in the Xian site.
- Actively participates as a member of the Site Leadership Team and partners with the Site General Manager.
- Serves as a member of the AP Quality Leadership team, to develop common quality strategies, benchmark best practices internatl and external to J&J.
- Partners with other IMSC Site Quality Heads and Global Quality to ensure harmonization and alignment with IMSC Quality Policies, Guidelines, Programs and Systems.
- Evaluates the functional strengths and developmental areas in the Xian Quality organization and focuses on continuous improvement.
- Assures the development of all subordinate staff to assume varied future opportunities. Partner with other Quality leaders to assure development opportunities are afforded to key talent – includes coaching, mentoring, etc.
- Contributing to the development of business and/or functional strategies, including partnering with the site General Managers and the broader operational organization in developing and executing the operational strategy and creating future opportunities.
- Explore synergies and barriers to supply chain and development interactions. Building processes to assure that appropriate touch points and hands offs are in place to assure overall organizational effectiveness.
- Establishes and maintains global relationships with partnering organizations and local/regional/national regulatory agencies.
- Analyses regulatory authorities ‘ programs and activities in areas relevant to China 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.
- Create the budget and monitors adherence to financial goals and restrictions.
- Fulfil quality head responsibilities to comply with Chinese GMP, EU GMP, Korea GMP and J&J quality policies.
- Responsible for participating in quality management activities such as establishment of the quality systems and effective operations.
Specifically -
- Ensure that the production and testing of each batch of released products are in accordance with the related regulations, the registration requirements and specifications.
- To ensure that all starting materials and packaging materials meet the registration requirements and specifications
- To ensure all necessary testing is carried out
- To approve specifications, sampling instructions, testing methods and other quality management procedures
- To review and approve all quality related changes
- To ensure all significant deviations and out-of-specification results are timely investigated and handled
- To approve and monitor any contract analysis
- To check the maintenance of premises and equipment for the purpose of maintaining a sound operation state
- To ensure the necessary qualifications or validations are done appropriately, and to review and approve validation protocols and reports
- To ensure self-inspection is done
- To assess and approve material suppliers with the support of EQSQ
- To ensure all quality related complaints are timely and properly investigated and handled
- To ensure the implementation of on-going stability study and make the stability data available
- To ensure that the product quality reviews are done
- To ensure that the necessary initial and continuing training of personnel in Quality Control and Quality Assurance is carried out and adapted according to need
- The review and approval of master manufacturing documents, procedures, etc.
- The approval contract manufacturers and monitoring contract manufacturers with EQ together
- The designation and monitoring of storage conditions form materials and products
- The monitoring of compliance with GMP
- Host quality system management review meeting and report the quality performance to the management
- Some responsibilities can be authorized to other qualified people when needed.
Additional Responsibilities/Duties
- Develop the tactical and operational plans for the quality department(s) and ensures that tactical objectives are met in support of strategic targets.
- Responsible for the overall management and effectiveness of the corrective action and preventive action (CAPA) and risk management processes.
- Plan, organize and oversee programs that will ensure the Xian site’s compliance to regulatory standards, including EMA as a business sustainable advantage.
- Provide technical leadership in administration of the Xian Quality Assurance functions supporting manufacturing efforts.
- Establishing “Best Practices” for GMP facilities that will ensure consistency between manufacturing sites.
- Oversees and leads quality investigations and/or internal audits to assess conformance to specifications, company procedures and overall compliance to regulations
- Oversees and ensures proper execution and compliance in complaint handling investigations.
- Ensures troubleshooting and solutions to quality issues through statistical analysis and process excellence tools. Present case studies and metrics to management.
- Overseas the quality review resulting from statistical and data analyses for projects, involving the design, development or validation of new or existing products and processes.
- Leads cross-functional teams and provides subject matter expertise to other departments
- Create customer-focused quality systems that ensure GMP compliance and facilitate business needs.
- Observes and promotes all regulatory requirements as defined per applicable regulations, rules and procedures established by the Company, and notifies any violation or deviation to the immediate supervisor or appropriate authority.
- Assures that all assigned personnel have the appropriate training and qualifications to perform all duties and responsibilities. Complies with own training requirements to perform duties of own job.
- Successfully completes regulatory and job training requirements.
- Understands and responsibly performs duties with attention to quality, safety and environmental matters.
- Implement supply chain quality strategy and combine it with Xi’an site quality target. Deliver budget and cost improvement target
- Support new product introduction projects. Maintain and upgrade corresponding certifications or license
- Develop good EHS system in department and have good execution. No LWDC and other EHS critical finding.