Director, Drug Quality – OUS & Qualified Persons
Mallinckrodt Pharmaceuticals, College Park, Maryland, us, 20741
**Job Title**Director, Drug Quality – OUS & Qualified Persons**Requisition**JR000015678 Director, Drug Quality – OUS & Qualified Persons (Open)**Location**College Park, Dublin - IRL006**Additional Locations****Job Description Summary**The Director, Drug Quality - OUS will be Quality Director for College Park Manufacturing Dublin, Sanda Manufacturing Japan and Kobe Testing Japan.
The Director, Drug Quality - OUS is responsible for the management of Quality Department at College Park Manufacture Facility and at the Sanda and Kobe sites in Japan. The person will work closely with other functions to ensure the implementation of a QMS and execution to meet all the required Quality, Compliance and Regulatory requirements at each site. The role includes complete signature authority, with responsibility for escalating high risk. The position also acts as a consultant to management regarding compliance issues. The incumbent will coordinate compliance activities / projects with key Mallinckrodt groups. In addition to the site Quality Leads, the QP for Acthar DPI will report to this position.
The Director, Drug Quality - OUS will ensure adequate and competent resources are in place at each location to oversee Manufacturing and Testing and that all personnel are trained to ensure adherence to regulatory and best practice requirements while delivering consistently to internal and external customers. This position plays an important role in the Quality Leadership team in supporting projects for driving improvements and efficiencies across sites.**Job Description**Essential Functions* Quality oversight and leadership for the College Park Manufacturing Ireland, Sanda Manufacturing Japan and Kobe Testing Japan.* Responsible for Inspection readiness including for all Regulatory Inspections including FDA, HPRA and PMDA.* Ensure the facility Quality Objectives and metrics dashboard are aligned with the Global Quality Management Systems and Global Quality Metrics, ensure adherence to metrics.* Leadership and oversight for Quality aspects at the sites.* Member of the Global Quality Leadership team which decides and implements strategy and direction.* Governance and maintenance of the College Park manufacturing facility Quality Management System as defined through the Site Master File, Technical Agreements, SOPs and Eudralex – Vol.4 GMP Guidelines* Oversight and Governance of all Product/Technical Transfer(s) with 3rd parties from a Quality perspective* Authorization and Approval of Change Records, Validations and Qualifications.* Communication with Competent Authorities as and when required.* Approval of 3rd party Technical Agreements on behalf of Mallinckrodt where required* Governance of all external and internal audit programs and plan, executing and following up on supplier site visits due to identified issues, validation/transfer activity or as routine periodic visits.* Responsible for ongoing inspection readiness program to ensure that Quality System(s) are managed and maintained in accordance with ICH Q7, Q10 and all applicable regulations.* Leading preparation and being the front room lead of regulatory inspections as required.* Responsible for maintaining compliance of licenses held by Mallinckrodt pertaining to College Park.* Ensuring knowledge of Quality and Compliance aspects for the products manufactured from Acthar API manufactured at College Park.* Management and development of members of the facility Quality Teams* Support continuous improvement efforts for projects identified at the suppliers or within the plants.* Participate actively on cross-functional operational and process improvement teams.* Seek to identify and execute safety improvements and waste minimization opportunities.* Assist in the application of appropriate quality technology tools to establish and maintain process capability and to resolve process deviations and product failures.* Build and maintain strong cross functional relationships across the site and across other Internal sites.* Responsible for supporting analytical method transfer, ongoing testing and stability program through review of associated documentation.* To ensure customer satisfaction through continuous improvement & RFT.* Prepare, review and approve documentation. SOP's, trending, metrics, training etc.* Ensure that any change controls and any formal investigations are conducted promptly and thoroughly .* Keep up to date with compliance and regulatory guidance* Lead and/or partner for the Annual Product Review process and lead in regulatory audits on QA aspects.* To ensure Key Performance Indicator's are known, promoted and achieved* To ensure Staff are appropriately trained and there is an appropriate level of cross training for activities and responsibilities within the team.* To ensure compliance with all EHSS site procedures.* undefined* Serve as Designated Person (DP) for the Active Substance Registration (ASR):o
Ensuring the conditions of the ASR are maintained by providing recommendations to ensure full compliance is met and maintained.o
Ensuring there is a robust and compliant quality management system (QMS) in place and that it is maintained in compliance with GDP requirements.o
Identifying regulatory compliance gaps or improvements within the company’s QMS and making suggestions as to the steps or actions to be taken to ensure gaps are closed and compliance with the conditions of the license are fully met.o
Ensuring that the company’s operations are set up in a way that the quality, safety and efficacy of AS are maintained by ensuring that adequate systems, procedures and controls are in place throughout the supply chain.o
Ensuring that all personnel involved in ASR activities are trained.o
Monitoring status of compliance of all relevant QMS processes as per established management review procedures and reporting/escalating to the company's leadership team when required.o
Ensuring that all quality and GDP related records, as required by the individual elements and procedures of the QMS, are completed, maintained and archived in a secure manner and in compliance with good documentation practices.o
Ensuring that customers and suppliers are approved.o
Ensuring that there are established systems and procedures in place for handling and recording customer complaints efficiently and effectively.o
Communicating with the relevant regulatory bodies as required, with respect to activities as they apply to the ASR.o
Reviewing and maintaining the ASR accuracy in order for it to include and reflect the correct and necessary authorised activities for the company.o
Submitting requests for ASR variations to the local authorities as and when needed.o
Ensuring they have sufficient knowledge on the products the company distributes and of the complexity of the operations related to the distribution of the products.o
Ensuring they are up to date with any changes in the relevant legislations.o
Participating in recall decisions including supporting product recalls.o
Ensuring adequate supervision and co-ordination of any product recall to allow for prompt execution of recall activities.o
Providing any other duties or giving such other advice properly associated with the duties of a DP under the terms of the License.* Serve as Qualified Persons for Acthar Drug Product Intermediate.
+ QP release of Acthar Bulk Drug product Intermediate in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16.
+ QP/Quality Professional will support preparation for HPRA, FDA and other regulatory audits.
+ Review relevant modifications of the Quality Management System (QMS), including new and updated current Good Manufacturing Practices (GDP/cGMP) Procedures, forms, and documentation in accordance with HPRA/FDA standards and requirements.
+ Participate in joint Quality #J-18808-Ljbffr
The Director, Drug Quality - OUS is responsible for the management of Quality Department at College Park Manufacture Facility and at the Sanda and Kobe sites in Japan. The person will work closely with other functions to ensure the implementation of a QMS and execution to meet all the required Quality, Compliance and Regulatory requirements at each site. The role includes complete signature authority, with responsibility for escalating high risk. The position also acts as a consultant to management regarding compliance issues. The incumbent will coordinate compliance activities / projects with key Mallinckrodt groups. In addition to the site Quality Leads, the QP for Acthar DPI will report to this position.
The Director, Drug Quality - OUS will ensure adequate and competent resources are in place at each location to oversee Manufacturing and Testing and that all personnel are trained to ensure adherence to regulatory and best practice requirements while delivering consistently to internal and external customers. This position plays an important role in the Quality Leadership team in supporting projects for driving improvements and efficiencies across sites.**Job Description**Essential Functions* Quality oversight and leadership for the College Park Manufacturing Ireland, Sanda Manufacturing Japan and Kobe Testing Japan.* Responsible for Inspection readiness including for all Regulatory Inspections including FDA, HPRA and PMDA.* Ensure the facility Quality Objectives and metrics dashboard are aligned with the Global Quality Management Systems and Global Quality Metrics, ensure adherence to metrics.* Leadership and oversight for Quality aspects at the sites.* Member of the Global Quality Leadership team which decides and implements strategy and direction.* Governance and maintenance of the College Park manufacturing facility Quality Management System as defined through the Site Master File, Technical Agreements, SOPs and Eudralex – Vol.4 GMP Guidelines* Oversight and Governance of all Product/Technical Transfer(s) with 3rd parties from a Quality perspective* Authorization and Approval of Change Records, Validations and Qualifications.* Communication with Competent Authorities as and when required.* Approval of 3rd party Technical Agreements on behalf of Mallinckrodt where required* Governance of all external and internal audit programs and plan, executing and following up on supplier site visits due to identified issues, validation/transfer activity or as routine periodic visits.* Responsible for ongoing inspection readiness program to ensure that Quality System(s) are managed and maintained in accordance with ICH Q7, Q10 and all applicable regulations.* Leading preparation and being the front room lead of regulatory inspections as required.* Responsible for maintaining compliance of licenses held by Mallinckrodt pertaining to College Park.* Ensuring knowledge of Quality and Compliance aspects for the products manufactured from Acthar API manufactured at College Park.* Management and development of members of the facility Quality Teams* Support continuous improvement efforts for projects identified at the suppliers or within the plants.* Participate actively on cross-functional operational and process improvement teams.* Seek to identify and execute safety improvements and waste minimization opportunities.* Assist in the application of appropriate quality technology tools to establish and maintain process capability and to resolve process deviations and product failures.* Build and maintain strong cross functional relationships across the site and across other Internal sites.* Responsible for supporting analytical method transfer, ongoing testing and stability program through review of associated documentation.* To ensure customer satisfaction through continuous improvement & RFT.* Prepare, review and approve documentation. SOP's, trending, metrics, training etc.* Ensure that any change controls and any formal investigations are conducted promptly and thoroughly .* Keep up to date with compliance and regulatory guidance* Lead and/or partner for the Annual Product Review process and lead in regulatory audits on QA aspects.* To ensure Key Performance Indicator's are known, promoted and achieved* To ensure Staff are appropriately trained and there is an appropriate level of cross training for activities and responsibilities within the team.* To ensure compliance with all EHSS site procedures.* undefined* Serve as Designated Person (DP) for the Active Substance Registration (ASR):o
Ensuring the conditions of the ASR are maintained by providing recommendations to ensure full compliance is met and maintained.o
Ensuring there is a robust and compliant quality management system (QMS) in place and that it is maintained in compliance with GDP requirements.o
Identifying regulatory compliance gaps or improvements within the company’s QMS and making suggestions as to the steps or actions to be taken to ensure gaps are closed and compliance with the conditions of the license are fully met.o
Ensuring that the company’s operations are set up in a way that the quality, safety and efficacy of AS are maintained by ensuring that adequate systems, procedures and controls are in place throughout the supply chain.o
Ensuring that all personnel involved in ASR activities are trained.o
Monitoring status of compliance of all relevant QMS processes as per established management review procedures and reporting/escalating to the company's leadership team when required.o
Ensuring that all quality and GDP related records, as required by the individual elements and procedures of the QMS, are completed, maintained and archived in a secure manner and in compliance with good documentation practices.o
Ensuring that customers and suppliers are approved.o
Ensuring that there are established systems and procedures in place for handling and recording customer complaints efficiently and effectively.o
Communicating with the relevant regulatory bodies as required, with respect to activities as they apply to the ASR.o
Reviewing and maintaining the ASR accuracy in order for it to include and reflect the correct and necessary authorised activities for the company.o
Submitting requests for ASR variations to the local authorities as and when needed.o
Ensuring they have sufficient knowledge on the products the company distributes and of the complexity of the operations related to the distribution of the products.o
Ensuring they are up to date with any changes in the relevant legislations.o
Participating in recall decisions including supporting product recalls.o
Ensuring adequate supervision and co-ordination of any product recall to allow for prompt execution of recall activities.o
Providing any other duties or giving such other advice properly associated with the duties of a DP under the terms of the License.* Serve as Qualified Persons for Acthar Drug Product Intermediate.
+ QP release of Acthar Bulk Drug product Intermediate in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements of Annex 16.
+ QP/Quality Professional will support preparation for HPRA, FDA and other regulatory audits.
+ Review relevant modifications of the Quality Management System (QMS), including new and updated current Good Manufacturing Practices (GDP/cGMP) Procedures, forms, and documentation in accordance with HPRA/FDA standards and requirements.
+ Participate in joint Quality #J-18808-Ljbffr