Associate Director of Product Quality
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Job Type | Permanent |
Area | Dublin, Ireland |
Sector | QualityLaboratory/Scientific |
Start Date | |
Advertiser | Mary King |
Job Ref | 1002654 |
Job Views | 438 |
- Description
- Team Horizon is seeking an Associate Director of Product Quality for our client based in Dublin. The Associate Director for Product Quality is responsible for systems and processes associated with finished product including product release and post manufacturing Quality. This position interfaces and collaborates with corporate and other site management in assuring that the company team is fully compliant with HPRA, FDA and corporate standards and is also eligible to act as a QP (Qualified Person). The Associate Director of Product Quality will have the responsibility of supervising a team of QPs, QA Specialists and QA Technicians and will report into the site Quality Director.
Why you should apply:
This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Provide strategic and tactical direction for the QA Post-Production Quality Systems design and maintenance while managing key site quality systems such as Non-Conformances, CAPA, Complaints and Product Quality Reviews.
Assist the QA Compliance group as appropriate for Internal Auditing, Technical Agreements and Site Master File maintenance.
Ensure site compliance with HPRA, U.S. Food and Drug Administration and other regulatory authority regulations, as appropriate while supporting a culture of constant site readiness for site inspections
Support daily activities, ensuring QA personnel execute their work in strict accordance with SOPs, and cGMP guidelines while also serving as a key participant in site regulatory inspections and SLA (Service Level Agreements).
Seek process innovation and continuous process improvement in QA function and provide direction to ensure that specified targets for team are met.
Maintain accountability for own team’s performance metrics ensuring data reports on team’s performance are current, accurate, and distributed according to defined procedures.
Establish a supportive environment, to ensure that staff has the capability to meet performance expectations by providing hands on training, support, and coaching to reports.
Contribute to the continual improvement of QA documentation and ensure that they are current, accurate, and clearly define process and role responsibilities.
Always maintain a knowledge of the Role and Responsibilities of the Qualified Person, for example, familiarisation with literature such as ECA Good Practice Guide for Qualified Persons within the EU.
Ensure each batch certified and its manufacture complies with the provisions of the marketing authorisation including the authorisation required for importation of IMP’s where relevant).
Ensure all necessary checks and tests are adequate and performed correctly.Maintain a register (or equivalent, i.e. SAP) as a record of product batches certified by the QP prior to release.
Prepare and conduct performance appraisals in accordance with Company guidelines while leading department initiatives and projects
What you need to apply:
Bachelor’s Degree or above in Chemistry, Pharmacy or related Science and or post graduate qualification in Pharmaceutical Manufacturing Technology which ensures the eligibility requirements for acting as a Qualified Person as defined in directive 2001/83/EC of the European Parliament.
At least 10 years relevant Pharmaceutical Quality experience and 3-5 years supervisory experience. This experience does not have to be limited to Quality Assurance.
Demonstrated success in managing a team in a pharmaceutical production environment and providing leadership in a technical environment
Experienced and knowledgeable in EU and FDA cGMPs
Experienced in interacting with regulatory authority inspectors
Experience in managing by metrics
Experienced in aligning individuals and teams to business objectives
Exposure to Lean manufacturing concepts