Job Title
Director, Drug Quality – OUS & Qualified PersonsRequisition
JR000015678 Director, Drug Quality – OUS & Qualified Persons (Open)Location
College Park, Dublin - IRL006Additional 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.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.
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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 Review meetings minimally on an annual basis to review mutually agreed key performance indicators.
Advise on QMS updates, quality agreement updates and license variations as required.
Shall cooperate in the exchange of information and assistance, as reasonably necessary to effectively respond to inquiries by regulatory authorities regarding the Product(s).
Review responses to regulatory audit findings (related to the MIA) from the other Parties.
QP/Quality Professional must ensure that they are fully up to date with the Regulations/Guidelines, Legal Requirements and can carry out the services of Qualified Person as stated under EU/HPRA Directive/Regulations or Guidelines.
The QP/Quality Professional shall make himself available by phone, e-mail as required in addition to the monthly time agreed on an urgent basis to assist the Company for the duration of this assignment.
Mutually agree notification to the competent authorities of any product identified as or suspected to be falsified.
Notify Parties within one (1) business day if any problems are discovered that may affect Product batches already shipped in order to assure that regulatory reporting guidelines may be met.
Cooperate fully regarding any proposed recall, product withdrawal or field action; and the Parties agree to keep each other advised, and to exchange copies of such documentation as may be required, to assure regulatory compliance and meeting both Parties regulatory obligations.See attached profile
At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence.
We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.
We are Keenova—keen to solve, keen to serve. Learn more at www.keenova.com.