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OVERVIEW
The Quality and Compliance Manager (EMEA Sub-Regional lead) provides quality support for work performed across multiple sites or sub-region for a specific client account 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 in their scope are performed in accordance with service agreements, quality agreements, JLL and Client procedures, ISO 9001:2015 and cGxP requirements. The role reports directly to the Regional Account Quality and Compliance Lead.

ESSENTIAL FUNCTIONS

Support the implementation and maintenance of the JLL ISO 9001 QMS and cGxP requirements on the account.
Support the implementation and maintenance of the account Quality Management Plan (QMP).
Serve as the account quality contact and subject matter expert (SME) in the sub-region.
Support the implementation and maintenance of the Quality Agreement between JLL and the client for sub-region and/or sites in their scope.
Ensure training compliance in sub-region or sites in scope, through document reviews, self-assessments, audits, etc.
Support the implement Quality 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 in sub-region or sites in their scope.
Perform qualification of cGxP impacting vendors, establish quality agreements, conduct vendor quality performance reviews and maintain the account approved supplier list (ASL).
Interface and represent JLL with the client FM teams and reporting of regional KPIs on a monthly basis.
Interface and collaborate with client Quality team to ensure alignment, 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 audits (e.g. internal, certification, external audits and regulatory inspections)
Support the EMEA and global internal audit programs, as well as the Global ISO 9001 certification audits.
Support regional account quality reviews, status reports and reports on critical/key quality-related performance measurements.
Support a quality-first culture and identify/implement quality & compliance improvements.
Mentor, develop, and train account team members 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 sites in sub-region to ensure consistency in compliance and performance.
Support long-term planning initiatives geared toward operational excellence for the account.

ACCOUNT/SITE SPECIFIC REQUIREMENTS

Primarily based close to a key client site, with regular travel to various EMEA site locations as scheduled and required e.g. to conduct investigations, on-site quality assessments, support audits, training sessions, client meetings, etc.

EDUCATION AND EXPERIENCE

BSc degree in life science, engineering or equivalent.
Minimum of five (5) years of experience in quality and/or compliance in engineering, facilities management, production, 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.
Experience in supplier management in GxP 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/or GMP) and EMEA cGxP standards and regulations in Pharmaceuticals and/or MedTech.
Ability to communicate effectively in oral and written reports.
Good customer service skills and relationship building 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

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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Quality & Compliance Manager (EMEA Sub-Regional)

Job Description