Job Description
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
ESSENTIAL FUNCTIONS:
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 and optimise change control, deviation, and risk management processes. Apply these systems to various quality issues as they arise.
Conduct detailed and effective root cause analysis and CAPA systems management.
Perform Internal or Supplier Quality System Audits, as assigned. Support/host Regulatory or client audits as required. stability, labeling reviews, Q Agreement support
Conduct label reviews to support Regulatory filings and manufacturing activities.
Ability to collate stability data from the third party and conduct statistical analysis and interpretation.
Support the company Quality complaint system and conduct complaint investigations and report these.
Provide QA support in 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.
Initiative, creativity, and the ability to manage change and work effectively in a complex, rapidly changing 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
Knowledge of quality standards and regulatory guidelines and requirements relating to pharmaceutical and/or biotech products or combinations of same. An ability to adapt these regulations and standards to real-world scenarios resulting in a successful complaint resolution.
Highly motivated, intelligent individual with strong project management, analytical, problem solving and interpersonal skills
Demonstrate high ethical and professional standards, and demonstrates company values consistent with all customers and business partners
Excellent collaboration skills to optimise the relationship between internal and external partners.
Strong analytical background with strategic thinking capabilities and attention to detail
Self-starter and able to work on their own initiative
Strong inter-personal including the ability to work effectively in a team environment and to build collaborative relationships with peers and with other stakeholders
Ability to communicate effectively with all levels of management both verbally and in writing
Comfortable working in a fast-paced, high-energy, diverse environment
Ability to multi-task, consistently meeting deadlines on multiple projects and activities
Ability to work under tight deadlines and to organize and prioritise tasks
Comfortable working in a startup environment where QMS will expand and grow in support of company growth
SKILLS AND EXPERIENCE:
Product quality experience in the QA management of commercial and investigational medicinal products
Candidate should have minimum 5-7 years direct pharmaceutical/biotech (or combinations) quality related experience.
Experience of biological products would be an advantage, as would experience medical device quality management systems.
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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