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Job Description –

Regional Account Quality and Compliance Lead (EMEA)

OVERVIEW

The EMEA Account Quality & Compliance Lead provides quality oversight and support for work performed across multiple sites for specific client account(s) in the EMEA region, with particular emphasis on cGxP-related scope. The role holder is responsible for ensuring that work conducted by JLL facilities management teams, project teams and subcontractors at client sites across EMEA are performed in accordance with service agreements, quality agreements, JLL and Client procedures, ISO 9001:2015 and cGxP requirements. The role leads the EMEA Quality & Compliance team and activities for the account(s) in scope across the EMEA region. The role reports directly to the regional functional Lead.

ESSENTIAL FUNCTIONS

• Implement and maintain ISO 9001 and cGxP requirements on the account in region.
• Develop, implement and maintain the account Quality Management Plan (QMP), and serve as the account quality subject matter expert (SME) in EMEA.
• Lead/support the implementation and maintenance of the regional and/or site-based Quality Agreement between JLL and the client.
• Ensure regulatory, quality and training compliance on the account, through document reviews, self-assessments, audits, etc.
• Develop and implement Quality, risk and Compliance programs on the account, to ensure sustainability of service quality.
• Prepare and manage quality documentation e.g. SOPs, change control documentation, quality agreements, training materials, investigations, CAPA, etc.
• Lead and support JLL quality related complaints, change controls, deviations, investigations, root cause analysis (RCAs) and CAPAs.
• Perform qualification of cGxP impacting vendors, establish quality agreements, conduct vendor performance reviews and maintain the account approved supplier list (ASL).
• Interface and collaborate with client Quality team to ensure adherence to client procedures, compliant documentation, delivery of reports and address quality-related concerns.
• Represent JLL and act as the single-point-of-contact (SPOC) during client-related internal, external audits and regulatory inspections
• Support the EMEA and global internal audit programs, as well as the Global ISO 9001 certification audits.
• Perform regional account quality reviews, status reports and reports on critical/key quality-related performance measurements.
• Develop and sustain a quality-first culture and identify/implement quality & compliance improvements.
• Strategically lead staff by providing effective and clearly communicating expectations, accountabilities and providing feedback for continuous improvement.
• Mentor, develop, and train account team members and direct reports on quality and compliance matters.
• Collaborate with quality colleagues regionally and globally to share and reapply learnings, successes, and best practices.
• Coordinate and standardise quality practices across the account's EMEA sites to ensure consistency in compliance and performance.
• Support long-term planning initiatives geared toward operational excellence for the account.

ACCOUNT/SITE SPECIFIC REQUIREMENTS

• Travel to various EMEA site locations as required to conduct investigations, on-site quality assessments, audits, training sessions, client meetings.

EDUCATION AND EXPERIENCE

• BSc degree in life science, engineering or equivalent.
• Minimum of five (7) years of experience in quality and/or compliance in engineering, facilities design, and production/facility operations, lab operations or equivalent
• Prior experience working in a GMP environment preferably in pharmaceutical and/or biotechnology.
• Experience leading investigations, change control, root cause analysis (RCAs) and CAPAs in a regulated environment.
• Strong leadership experience and experience interacting at all levels.

KNOWLEDGE, SKILLS, AND ABILITIES

• Strong knowledge and understanding of Quality Management Systems (ISO 9001, ISO 13485) and EMEA cGMP standards and regulations in Pharmaceuticals.
• Ability to communicate effectively in oral and written reports.
• Good customer service skills
• Must be self-motivated, detail oriented, comfortable working in a dynamic team environment with minimal supervision.
• Demonstrated ability to lead, influence with & without authority and partner with people across multiple business areas.
• Capable of writing detailed technical reports.
• Ability to multi-task and respond within deadlines.
• Excellent IT skills and proficient in Microsoft excel, word, outlook, power point and access.

Location:

On-site –Cork, IRL, Dublin, IRL

If this job description resonates with you, we encourage you to apply even if you don’t meet all of the requirements.  We’re interested in getting to know you and what you bring to the table!

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