Quality Compliance Manager- GMP Experience Required
Company: Jones Lang LaSalle
Location: Andover
Posted on: January 15, 2021
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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
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