Quality and Compliance Manager

4 days ago

Cork, Cork, Ireland JLL Full time
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).
  • Support the implementation of a 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 service quality.
  • Prepare and manage quality documentation e.g. SOPs, change control documentation, quality agreements, training materials, investigations, etc.
  • Lead and support JLL quality related complaints, deviations, investigations, root cause analysis (RCAs) and CAPAs.
  • Perform qualification of GxP 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 proper documentation, delivery of reports and address quality-related concerns.
  • Represent JLL and act as the single-point-of-contact (SPOC) during client-related internal or external audits.
  • Support the EMEA and global internal audit programs, as well as the Global ISO 9001 certification audits.
  • Perform account quality reviews and report 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 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, etc.
Education And Experience
  • BSc degree in life science, engineering or equivalent.
  • Minimum of three (3) 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 life sciences environment (e.g. pharmaceutical, medical devices, biotechnology, food, etc.).
  • Experience leading investigations, root cause analysis (RCAs) and CAPAs in a regulated environment.
Knowledge, Skills, And Abilities
  • Knowledge and understanding of Quality Management Systems e.g. FDA, EU & WHO GMP, ISO 9001, ISO 13485, etc.
  • 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 without authority and partner with people across multiple business areas.
  • Capable of writing detailed technical reports.
  • Ability to multi-task and respond within deadlines.
  • Proficient in Word, Excel and other Microsoft Office Suite programs.
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