Senior Director, Quality, External Manufacturing Dublin pharma
With a management team that includes unique world class expertise in their clinical field, our client is a young exciting biopharmaceutical company focused on the discovery of solutions to a number of serious debilitating diseases. Rapid expansion has led to the need to create a key global leadership role in Quality their Dublin office.
Primary Objective/ Purpose of Position:
Responsible for serving as the Quality representative on the External Manufacturing Leadership Team which oversees contract manufacturing operations and development functions and the Supplier Review Board. Responsible in this context for direction/supervision of the QA/QC aspects of commercial, IMP products, and development projects for all aspects of GMP. Reporting to the Senior Vice President of Quality. A member of the Technical Operations team, based in Dublin with team members based in USA and Dublin.
- Actively participate in the External Manufacturing Leadership Team with particular focus on enabling the team to efficiently achieving their business goals while being compliant with the required quality standards.
- Manage relationships with external manufacturers for Quality related activities, including being key company contact person for such relationships.
- Assist with troubleshooting quality issues at external manufacturers or associated with technology transfer, when required.
- Develop & maintain appropriate Quality or Technical agreements with all GMP vendors.
- Manage external manufacturer performance using external SME’s as appropriate.
- Review and report external manufacturer quality metrics including Annual Product Quality Review, APQR review.
- Attend Supplier Review Board and Quality Council meetings and advise corrective actions as appropriate.
- Act as a key SME during regulatory or customer audits of Dublin office activities.
- Participate in Recall/Mock Recall Committee meetings as appropriate.
- Manage a team of Quality professionals including QP’s in the following functions:
- QA Operations
- QA Projects
- QA Commercial Affiliates
- Manage Quality Control function which provides analytical support to both Development projects and commercial products including analytical method qualification & method transfer and product stability.
- Support the GMP vendor qualification programme including initial and ongoing qualification to ensure quality oversight of external manufacturers.
- Carry out other Quality related duties as occasionally requested by the SVP Quality, as required including audits, provision of QA support to key company pre-and post-approval development activities (e.g. Tech Transfers, Life cycle maintenance activities, Integration activities, technical diligence activities).
- Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines.
- Work directly with other key Company departments to ensure compliance and productive working relationships.
- Work directly with other members of the Quality department, as required, to provide support in the management of other GxP activities.
- Integrate, contribute, and/or lead cross-functional project teams as required. Support project schedules as required.
- Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.
- Live the company values.
- Bachelor’s degree in chemistry, biology, pharmacy or a related discipline. An advanced degree in biopharmaceutical science desirable.
- Significant experience (15+years) working in bio/pharmaceutical industry ideally including experience working with contract manufacturing organisations.
- Experience should be in the QA, QC, development, and/or manufacturing areas and include a minimum of 5 years in a senior leadership position within the bio/pharmaceutical industry.
- Experienced with and thorough understanding of regulatory agencies, the global regulatory requirements and associated guidance documents related to Pharmaceutical Quality Systems, GMP, GDP and IMP requirements.
- Experience leading and participating in GMP, GDP and IMP audits, including drug product manufacturing and analytical testing sites.
- Experience in the following desirable:
- Finished product manufacturing, particularly sterile product manufacture and biotechnological processes
- Analytical method development or executing analytical methods
- Process validation and/or IT compliance
Cv to Gerry@rftgroup.ie