EMEA Quality & Compliance Director – Laboratory Services
Salary: circa £70 – £95,000 + 15% Bonus + Car Allowance + Full Blue-Chip Company Benefits
Your Location: Living in the UK and commutable to an international airport
Do you currently hold the title and responsibility of Quality Director, Director of Quality, QA Director, Head of Quality & Compliance or Head of Regulatory Affairs?
Do you have experience of managing dynamic and diverse Quality & Compliance Teams?
Do you possess Life Sciences Quality & Compliance Leadership expertise having worked in a major Pharmaceutical, CRO, CMO, Biotech, Pharma, Laboratory Services or related field?
Are you tenacious, passionate, ambitious and results driven?
If you answered yes to the above, then this may be the ideal role for you…
The Requirements of the EMEA Quality & Compliance Director:
- To be considered for the EMEA Quality & Compliance Director role you must have a minimum of 8 year’s experience working as a Quality & Compliance Director for a leading Pharmaceutical research/Manufacturing quality organisation
- Ideally you will have experience working with organisations such as: Astra Zeneca Novartis, Pfizer, Roche, GSK or similar
- Educated to bachelor’s degree in Biology, Microbiology, Chemistry, or Engineering; or equivalent related work experience
- Quality auditing experience preferable
- Specialised training or certification in quality assurance audits, preferably FDA or ISO related preferred. Must have appropriate license and/or certification where required by law. Green or Black Belt Six Sigma Certification is preferable
- Experience with Desktop publishing, Microsoft Office Suite and Online Help. Previous experience with SAP, Trackwise, Regulus, and/or CMMS systems
- Well versed with Quality and Compliance management systems within Life Science Environment(s)
- You must have experience working in a compliance led and highly regulated industry
- You must have flexibility to travel both within the UK and to client sites within Europe
- This is a customer facing and commercially focused sourcing position, the successful candidate must be able to positively influence and work with senior level stakeholders
- Excellent interpersonal, writing, editing, analytical and organisational skills
The role of the EMEA Quality & Compliance Director:
- The purpose of this position is to lead the Quality & Compliance Team on large scoped client accounts (may include multiple accounts/clients)
- Assist with Tenders, Bids & RFP’s – attending client meetings as the Quality Lead to win new life science and laboratory accounts
- Assist with the transitioning of accounts once they have been won
- This role may lead corporate QA departments facilitating the company QA and Compliance objectives and how those objectives are cascaded to client accounts
- This role manages the staff that is responsible for the creation, implementation, and routine maintenance, of and/or the client’s Quality Management System (QMS)
- This role is responsible for the delivery of all quality and compliance deliverables for regulated and non-regulated services provided to the client; per the master service agreement, Quality agreement, and any local service level agreements
- Responsible for all contractual agreement aspects (MSA, QA, SLA) where regulated GxP quality and/or quality of service provided is stipulated. Ensures that my client is appropriately staffed to achieve the quality deliverables committed in those contracts
- Evaluates, selects, implements, and actualizes best practices across the client portfolio
- Researches, creates, and aligns quality initiatives with current regulatory bodies requirements as a function of the scope of work provided to the client
- Oversees the staff responsible for the quality & compliance program and/or the client’s compliance program. Attends Quality Forum monthly meetings to provide in-depth explanations for monthly reports and department metrics
- Leads and participates in continuous improvement objects for both the company and the client
- Interfaces, partners, and interacts with the clients’ leadership teams. Appropriately communicates quality and compliance initiatives and/or issues across the functional areas impacted. Responsible for reporting Compliance (among other quality and business metrics) status to the client during review meetings. Appropriately escalates and notifies the company and client management of quality and compliance issues
- Oversees the staff responsible for the inspection readiness program for the site
- Depending on staffing strategy, may have responsibility to lead audits as well as serve as the primary quality representative for my client’s operations during external agency or client audits. Is accountable to the client and/or agency for audit observations and the associated corrective measures
- Oversees the staff responsible for the vendor management program for the site. Ensures GxP compliance and qualification of all regulated service vendors
- Manages the staff(s) assigned to the Quality & Compliance Department (may involve multiple client accounts and staffs)
- Operating in multiple countries on a global scale my client is an industry leading 360-degree laboratory services provided for major multinationals in the Pharmaceutical & Life Sciences sector
- Key examples of these services include: Sourcing & Multi-vender management, Data Advisory, Programme Management and Innovation & Customer Engagement
For more information about the role or to apply send your CV now to firstname.lastname@example.org or call Emma Howarth today on +44 (0) 113 243 3499.
You must have the right to work in the EU.
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