Quality Compliance Manager- GMP Experience Required

Company: Jones Lang LaSalle
Location: Andover
Posted on: January 15, 2021

Job Description:

Quality Compliance ManagerJob SummaryManager must possess a strong background in quality assurance requirements for Biotech/Pharmaceutical facility operations and maintenance perspective. This position is responsible for ensuring that the work conducted by the Facilities Operations and Maintenance teams, and its subcontractors perform the work in full accordance and compliance with JLL, client policies and procedures, and FDA cGMP regulations. The Manager role must have a solid understanding of cGMP---s as they relate to the performance of maintenance and repairs to equipment utilized for the manufacturing of drug products and control of workplace environment. Ensure JLL staff and subcontractors are compliant with all client and regulatory training. QC Manager must have a strong commitment to quality assurance, and a willingness to support the quality first culture for JLL Life Sciences accounts. Must be self-motivated, detail oriented and comfortable working in a dynamic team environment with minimal supervision.Essential Duties: Customer Relationships (Client)Ensure client satisfaction with delivery of facility management services and provide a lead role in monitoring and increasing regulatory and statutory compliance.Develop excellent partnership with clients through trust, actions and resultsComply with all GMP and Non-GMP requirements of the Client contracts and meet or exceed key performance indicators. Deliver an exceptional quality of service to the clients, as reflected by client feedback.Ensure training compliance within JLL scope of work.Be an active member of the JLL Life Sciences Quality Council, participate in and lead initiatives, share learnings with the council and share best practices and improvement to the accounts Leadership Management (People)Foster a proactive environment of teamwork, cooperation, excellence of performance and personal success. Act as role model for JLL by behaving consistently with cultural, ethical requirements and participating in company activities.Support individual performance management program, and responsible for personal development planning process. Promote safety culture within portfolio including clients, subcontractors, suppliers and visitors.In collaboration with managers, develop training curriculum for all JLL staff and subcontractor roles within JLL scope of work.Service Delivery (Growth)Primary responsibility is to lead regulatory and quality assurance programs and requirements in a GxP environment by ensuring all facilities services and documentation in full accordance and compliance with JLL, client policies and procedures, and FDA cGMP regulations.Accountable to provide specific quality assurance assistance to the facility management teams as needed or requested.Responsible for executing the JLL Quality Compliance program for cGMP manufacturing facilities such as training verification, facility self-assessment, documentation control, personnel qualification files, vendor/suppliers audits and site programs relating to regulatory or statutory compliance. Reads and understands the applicable Service Level Agreements, helps achieve the Key Performance Indicators and scores favorably on the client satisfaction surveys.Support EHS teams in full compliance with all EHS programs requirements.Responsible to prepare and revise SOP---s, change control documentation, investigations, discrepancies, CAPA---s, GDP---s and training materials used by the facilities maintenance team in the performance of their work and also is accountable to keep updated applicable quality management system or software (Ex. TrackWise) in place.Interface with the client---s SME---s to ensure that applicable client SOP---s are followed, and that the work performed by the team is documented and recorded for accuracy and compliance with all applicable regulations, international standards, and internal procedures.Review, consult, and approve (as authorized) risk analysis performed for facilities operation at site level.Support new hire induction program and validate JLL sub-contractor---s services against contract/service labor agreement. Comply with all GMP and Non-GMP requirements of the client contract and meet or exceed key compliance requirements.Ensure compliance of all regulatory laws and guidelines are met in accordance to their SOP---s by maintaining JLLs practices across all facilities services to meet client and authority having jurisdiction (AHJ) compliance requirements.Lead in the completion of the facilities operations audits and assessments requirements, and full responsible of site audit readiness program.Support Business Continuity Planning activities, and participate as a key team member in responses to emergency situations.Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.Owns program processes and ensures all requirements for facility are met.Execute additional job duties as requests, analysis and reporting.Seeks to continuously improve quality processes, systems and overall client satisfaction.Account Specific Responsibilities:Review GxP Work OrdersKPI Scorecard review and governanceParticipate, prepare, and lead, if applicable, internal and external auditsProvide Quality training as neededCoordinate and manage GxP vendors, including vendor qualification packages, audits, and monitoring service performanceCAPAs creation, review, closeout and lessons learnedAssure ongoing compliance with JLL Quality, Client Quality, and Regulatory requirementsPrepare reports to communicate outcomes of quality activitiesInterpret and implement quality assurance standardsDraft and execute client quality agreementsLead Significant Events/Deviations investigationsReview GxP Change ManagementQualifications: BA/BS in engineering is preferred, or equivalent quality engineering and production/facility operations experience.Have a minimum of four to seven (4) years of regulatory quality and statutory compliance experienceHave a minimum of five (5) years of experience in Pharma, Biotech or similar life science sector that are governed in GMP regulations, systems and processes working in a Quality Assurance role.Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management SystemsProven record of excellent internal and external customer serviceExcellent verbal and written communication skillsAdvanced computer and office software skills is requiredLI-KS5JLL Privacy NoticeJones Lang LaSalle (JLL), together with its subsidiaries and affiliates, is a leading global provider of real estate and investment management services. We take our responsibility to protect the personal information provided to us seriously. Generally the personal information we collect from you are for the purposes of processing in connection with JLL---s recruitment process. We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons. We will then delete it safely and securely.For more information about how JLL processes your personal data, please view our Candidate Privacy Statement.For additional details please see our career site pages for each country.For employees in the United States, please see a fully copy of our Equal Employment Opportunity and Affirmative Action policy here.Jones Lang LaSalle (---JLL---) is an Equal Opportunity Employer and is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process --- including the online application and/or overall selection process --- you may email us at Accommodation.Requesam.jll.com. This email is only to request an accommodation. Please direct any other general recruiting inquiries to our Contact Us page > I want to work for JLL.Full time

Keywords: Jones Lang LaSalle, Boston , Quality Compliance Manager- GMP Experience Required, Executive , Andover, Massachusetts