Quality Assurance Manager
|Contact Name:||Laurentina Kennedy|
The QA Manager is responsible for supporting the creation, execution, and maintenance of quality management systems (QMS) to ensure adherence to Quality standards and Regulatory requirements for their commercial and development products/projects which encompass Combination Drug-Medical Devices, small and large molecule products.
This position provides strategic and tactical management of Quality activities collaborates with cross-functional team members and or contract manufacturers and external service providers. This position reports to the Quality Director to provide robust and timely Quality and Regulatory support that aligns across functions to execute the plan and accomplish results.
This role gives an opportunity for an individual to further develop their career path by big exposed to many varied QA experiences in a fast moving dynamic environment
Develop an intimate understanding of drug product manufacturing processes and products and apply quality management system procedures to these. This includes batch review and release.
Understand the relationship between regulatory filings and QMS and utilise these in the oversight of compliant Quality activities.
Develop, adapt, optimise change control, deviation, and risk management processes
Carryout detailed and effective root cause analysis and CAPA systems.
Perform Internal or Supplier Quality System Audits, as assigned. Support/host Regulatory or client audits as required.
Provide QA support for projects relating to commercial and investigational medicinal products.
Author and/ or contribute to regulatory annual product reviews.
Partner with internal partners and contract manufacturing and services organisations and other cross-functional groups to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
Review and release of manufacturing and analytical test documentation in support of the release of batches of product for commercial distribution. Coordination of review processes with 3rd party support vendors.
Develop strong technical and business relationships with contract manufacturing and services partners to support addressing supply chain goals, objectives, and process improvements.
Works in close partnership with other cross-functional partners to meet timelines and achieve business results.
Ensure compliance with all laws, regulations, and policies that govern the conduct of the company.
KNOWLEDGE AND SKILL REQUIREMENTS:
Demonstrated skills and experience in the conduct of Quality activities as described above in support of pharmaceutical and/or biotech products or combinations of same.
The initiative, creativity, and the ability to manage change and work effectively in a complex, rapidly changing the environment and feel comfortable in this environment.
Strong communication skills and multi-tasking capabilities
Ability to navigate cross-functionally and strategically leverage relationships to achieve business results
Candidate should have minimum 4-6 years direct pharmaceutical/biotech (or combinations) quality related experience.
Experience of biological products would be an advantage
Start-up or launch experience preferred
Ability to travel required. Anticipated travel: 10-25 %
For further information on this QA Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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