QA Team Lead
5 days left
- Experience Level
Hobson Prior are recruiting for a QA Team Lead for an exciting permanent position at a Biotech organisation in London. Our client is determined to develop possible curative treatments for patients who are living with serious illnesses.
- Accountable to lead, supervise, manage and train the QA Quality System team and continuously improve the local Quality system.
- Provide training & support for Quality relevant systems in UK, NL, USA and Ireland.
- Management and oversight of the document control process from creation to obsoleting including approval, management and archiving.
- Generation, Review and approval of relevant GMP documentation
- Assure compliance to EU and FDA GxP, the organisation's QMS and QA GMP operations, any other applicable regulations/standards
- To act as SME for the Quality Management System and Documentation processes at regulatory and 3rd party audits
- Manage the Quality Council meeting, co-ordinating presentation preparation, fronting the meeting, preparing the minutes and assigning/ tracking the actions.
- Compile quarterly Quality metrics (KPI's) for site.
- Provide KPI data for the Tier 3 meeting.
- Assure compliance to FDA and MHRA regulations and ensure retention of MIA(IMP) and MS Licenses
- Ensure the organisation remains inspection ready.
- Lead "Level 1" meetings for QA team.
- Partake in Tier 2 meetings, representing the QA team and escalating to the QA Director-GMP as required
- Oversight, review and management of Risks, Quality Events including incidents, deviation, investigations, change controls and CAPA ensuring they meet timelines.
- Partake in the self-inspection process.
- Coordinate preparation activities for Regulatory inspections and provide support to regulatory inspections as required by the QA Director-GMP.
- Any other assigned duties.
- Understanding controlled processes.
- Excellent verbal and written communication skills.
- Excellent interpersonal skills with the ability to appropriately challenge others behaviours.
- Pragmatic / common sense approach to quality incidents.
- Proficient in Microsoft Office and experience in database use and eQMS systems.
- Planning/Organizing- prioritises and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules other people and their tasks; develops realistic action plans.
- Excellent interpersonal skills.
- You will have a relevant Science based degree e.g. Chemistry, Biology, Pharmacy.
- Experience in leadership within QA
- Experience of working within a Sterile/ Aseptic GMP manufacturing environment.
- Experience in Competent authority, Regulatory body inspections and audits.
- Prior experience working in a GxP environment including a minimum 6 years' experience in Compliance and Quality Assurance.
- Working knowledge of the principles and guidelines for cGMP as out in UK "Orange Guide", EU "Eudralex Volume 4", U.S. "CFRs" and other relevant regulations/guidelines.
- Working and hands on experience with defining and implementing Quality Management Systems.
- Leadership and Management experience of successfully managing small teams is preferred.
- IT literate, experience managing and operating an electronic QMS.
- Knowledge of GMP with regards to QMS activities.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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