Build successful relationships with Life Sciences (LS) client stakeholders to promote confidence in quality and compliance, as well as forward planning.
Provide management and leadership direction for the development and implementation of quality and compliance programs.
Collaborate with other Life Sciences accounts to proactively accumulate, share and reapply all learnings, successes as well as best practices.
Collaborate with Global Life Sciences Quality Vertical for development, revision and implementation of QMS and quality documents.
Responsible for ensuring Lide Sciences facilities teams adhere to the required training and ensuring in compliance to client’s QMS and quality training requirements.
Responsible for ensuring that the work conducted by the Facilities team, and its subcontractors is in full compliance with contractual requirements, client’s SOP’s, GxP, FDA and other regulations.
Able to perform/support internal JLL compliance audits and prepare SOP’s, and training materials for use by the Life Sciences facilities team in the performance of their work.
Guide Life Sciences facilities team in closing recommendations from client’s audit.
Expected to interface with the client’s quality personnel to ensure that all of the clients SOP’s are followed, work performed by the LS facilities team is properly documented for traceability in the framework of GDP.
Sustain quality assurance support and develop a Quality Engineering Maintenance program for a controlled-environment manufacturing and laboratory facility as it relates to the facilities maintenance of this plant. Conduct investigations and drive accountability for all quality events.
Lead programs to create value for client to ensure program deliveries meet or exceed expectations.
Facilitate quality-relevance investigation via structured Root Cause Analysis.
As part of career development, lead Life Sciences accounts as an IFM leader.

Reporting

Manage and report on critical & key performance measurements. Develop and submit periodic site status reports related to the Quality Program.

People Management

Effectively lead and guide a Life Sciences Quality team by clearly communicating expectations, accountabilities and providing performance feedback for continuous improvement.
Ensure Life Sciences Operations team members complete relevant quality and compliance training.
Coach new Life Sciences team members on quality and compliance for their adaptation into specific Life Sciences accounts.
Mentor, develop and train peer and direct report team members.
Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.

Others

Any other quality-relevant duties and tasks assigned.

Minimum Required

Knowledge, Skills & Abilities

Preferred

Education/training

Bachelor degree preferred
Degree in science, technical or relevant discipline
Sound fundamental knowledge in process utilities.
6+ Years of relevant experience preferred with minimum 4+ years in Quality and Compliance discipline in GxP manufacturing or laboratory environment.
Six-Sigma and Root Cause Analysis training is essential.

Skills and knowledge

Background in technical documentation
Work independently and within a team.
Strong mindset of compliance and client-focus.
Communicate effectively with technical, quality assurance and other personnel.
Proficient in Word, Excel and other Microsoft Office Suite programs
Ability to investigate, recognize and diagnose trends and patterns.
Solid understanding of cGMP’s as they relate to the performance of maintenance and repairs to facilities, utilities and equipment utilized for the manufacturing plants and laboratories for drug products.
Experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity.
Support investigations and corrective action plans for appropriate discrepancies.
Investigation of compliance issues as required, collaborating with relevant Compliance Partner(s)
Understanding of FDA regulations including 210 CFR part 210 and 211.
Strong commitment to quality assurance, and a willingness to help develop a quality first culture on the site.
Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems
English communication is essential

Other Abilities

Good oral and written communication skills including the ability to communicate to all levels of management and willing to interface with a diverse customer base including technical and non-technical personnel.

Physical work requirements and work conditions

Familiar with process utilities and GxP environment.

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