Quality & Compliance Manager

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OVERVIEW

The Quality and Compliance Manager provides quality support for work performed on a sites(s) for 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 Quality and Compliance Lead.

ESSENTIAL FUNCTIONS

• Support the implementation and maintenance of the JLL ISO 9001 QMS and cGxP requirements.

• Support the implementation and maintenance of the account and site Quality Management Plan (QMP).

• Serve as the quality contact and subject matter expert (SME).

• Support the implementation and maintenance of the Quality Agreement between JLL and the client for region and/or sites in their scope.

• Ensure training compliance for 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 on site.

• Perform qualification of cGxP impacting vendors establish quality agreements conduct vendor quality performance reviews and maintain the approved supplier list (ASL).

• 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) for site issues and 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 site and regional account quality reviews status reports and reports on critical/key quality-related performance measurements.

• Support and champion 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 on site to ensure consistency in compliance and performance.

• Support long-term planning initiatives geared toward operational excellence for the site and account.

ACCOUNT/SITE SPECIFIC REQUIREMENTS

• Site based

EDUCATION AND EXPERIENCE

• 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 or equivalent

• Strong 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 experience interacting at all levels and leading without autonomy.

KNOWLEDGE SKILLS AND ABILITIES

Strong knowledge and understanding of Quality Management Systems (ISO 9001 ISO 13485 and/or GMP) and 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.

• Fluency in German and English (speaking and writing) required

Location:

If this job description resonates with you we encourage you to apply even if you dont meet all of the requirements. Were interested in getting to know you and what you bring to the table!

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