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Director, Quality & Compliance
Andover, MA
Job Description
OVERVIEW
The Quality & Compliance Director, will have a primary function of ensuring that the Account's Quality & Compliance Program is properly implemented, maintained, and continuously improved. The person must have a strong background in quality and regulatory requirements for GxP facilities from an operations, facilities, and maintenance perspective. The role will strive towards regulatory, procedural, and contractual compliance ensuring Audit Readiness status across the account. This Quality & Compliance Director will collaborate with the account's team to ensure effective participation in, and adherence to, quality programs. Together, they will drive towards a higher level of service as well as achieve expected scoring performance metrics, as stipulated in both Client and Third Party Vendor contracts.
In addition, this position is expected to interface with the client's quality unit to ensure that, through established Quality Agreement, all applicable regulations and procedures are followed, and that the work performed by staff is documented and recorded in the proper fashion. This person must have experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity with a solid background understanding of GxP regulations.
The Quality & Compliance Director must also have a strong commitment to quality assurance, and a willingness to help develop a quality first culture across the account. Must be self-motivated, detail oriented, comfortable working in a dynamic team environment with minimal supervision. The person must have good oral and written communication skills including the ability communicate to all levels of management and interface with a diverse customer base including technical and non-technical personnel.
RESPONSIBILITIES:
Develop, implement, support and direct quality programs ensuring that program deliveries meet or exceed expectations
Build successful relationships within account's personnel and other client personnel to promote confidence, forward planning, and best practices
Provide management and leadership for the design, development, implementation and sustainability of the account's quality and compliance programs
Collaborate with account wide team and proactively share and reapply all learnings, successes, and best practices
Provides management/information to JLL third-parties, account staff and service providers as required to ensure that quality assurance expectations and changes to industry regulations are communicated and followed.
Responsible for supporting and managing the account's quality programs (i.e. non-conformance investigations, CAPAs, training compliance, vendor qualifications, third-party quality agreements, external audits, self-assessments, document management, GxP change control, etc.) that ensures that the work conducted by the Facilities team, and its subcontractors, perform the work in full accordance with applicable SOP's, industry regulations, current practices and contractual requirements
Management of the GxP third-party vendors' compliance program (e.g., qualification, agreements, audits, performances, etc.)
Development and review of trend analysis reports related to the facility scope of work
Maintain all infrastructure and compliance documentation for the facility for the purpose of maintaining regulatory compliance with Contractual, Procedural, Federal, State or Local law requirements
Seeks to continuously improve quality processes, systems, and overall client satisfaction
Interface with the client's quality personnel to ensure that all the client's requirements are followed, and that the work performed by the team is documented and recorded in the proper fashion
Develops and submit periodic account status reports related to its Quality Programs
Supervise, mentor, develop and train peers and direct report team members, when applicable
Ensure that JLL's Life Sciences Quality Management System is properly implemented and consistently met, including all ISO 9001:2015 requirements
Actively collaborate with the Life Sciences Quality Council
Any other duties and tasks as deemed necessary
QUALIFICATIONS:
BS degree in science is desired
A minimum of 8 years of experience in quality engineering, facilities design, and production/facility operations or equivalent. Strong related experience in lieu of degree may be acceptable.
Knowledge of Quality Engineering techniques such as Investigations, RCAs, CAPAs, Audit programs, Vendor Qualification, and Quality Management Systems
EIT or PE a plus
PC skills, proficient in all MSOffice applications, in particular Excel, Word, PowerPoint
Working knowledge of Quality Management Software such as TrackWise, MasterControl, Success Factors, Infinity, etc.
Oral and written communication skills including the ability communicate to all levels of management and will interface with a diverse customer base including technical and non-technical personnel
Ability to prepare and analyze technical reports for the purpose of ensuring compliance with regulations, procedures, and contractual responsibilities
Proven record of excellent internal and external customer service experience
Thorough understanding of cGxP's as they relate to the facilities, utilities, equipment, and laboratories supporting manufacturing activities of drug products
JLL Is an Equal Opportunity Employer JLL is committed to developing and maintaining a diverse workforce. JLL strongly believes in equal opportunity extended to all individuals in all aspects of the employment relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination without regard to race, color, religion, belief, creed, age, sex, pregnancy or maternity (including childbirth and related conditions), family responsibility (e.g. child care, elder care), nationality, ethnic or national origin or ancestry, citizenship, marital status, civil partner status, sexual orientation, gender identity or expression, transgender status, veteran’s status, genetic information, trade union membership, social position, political view or status as a qualified individual with a disability, protected leave status or any other protected characteristic in accordance with applicable law. The company also endeavors to make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodations would impose an undue hardship on the operation of our business and ensures that employment decisions are based only on valid job requirements.
The Quality & Compliance Director, will have a primary function of ensuring that the Account's Quality & Compliance Program is properly implemented, maintained, and continuously improved. The person must have a strong background in quality and regulatory requirements for GxP facilities from an operations, facilities, and maintenance perspective. The role will strive towards regulatory, procedural, and contractual compliance ensuring Audit Readiness status across the account. This Quality & Compliance Director will collaborate with the account's team to ensure effective participation in, and adherence to, quality programs. Together, they will drive towards a higher level of service as well as achieve expected scoring performance metrics, as stipulated in both Client and Third Party Vendor contracts.
In addition, this position is expected to interface with the client's quality unit to ensure that, through established Quality Agreement, all applicable regulations and procedures are followed, and that the work performed by staff is documented and recorded in the proper fashion. This person must have experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity with a solid background understanding of GxP regulations.
The Quality & Compliance Director must also have a strong commitment to quality assurance, and a willingness to help develop a quality first culture across the account. Must be self-motivated, detail oriented, comfortable working in a dynamic team environment with minimal supervision. The person must have good oral and written communication skills including the ability communicate to all levels of management and interface with a diverse customer base including technical and non-technical personnel.
RESPONSIBILITIES:
Develop, implement, support and direct quality programs ensuring that program deliveries meet or exceed expectations
Build successful relationships within account's personnel and other client personnel to promote confidence, forward planning, and best practices
Provide management and leadership for the design, development, implementation and sustainability of the account's quality and compliance programs
Collaborate with account wide team and proactively share and reapply all learnings, successes, and best practices
Provides management/information to JLL third-parties, account staff and service providers as required to ensure that quality assurance expectations and changes to industry regulations are communicated and followed.
Responsible for supporting and managing the account's quality programs (i.e. non-conformance investigations, CAPAs, training compliance, vendor qualifications, third-party quality agreements, external audits, self-assessments, document management, GxP change control, etc.) that ensures that the work conducted by the Facilities team, and its subcontractors, perform the work in full accordance with applicable SOP's, industry regulations, current practices and contractual requirements
Management of the GxP third-party vendors' compliance program (e.g., qualification, agreements, audits, performances, etc.)
Development and review of trend analysis reports related to the facility scope of work
Maintain all infrastructure and compliance documentation for the facility for the purpose of maintaining regulatory compliance with Contractual, Procedural, Federal, State or Local law requirements
Seeks to continuously improve quality processes, systems, and overall client satisfaction
Interface with the client's quality personnel to ensure that all the client's requirements are followed, and that the work performed by the team is documented and recorded in the proper fashion
Develops and submit periodic account status reports related to its Quality Programs
Supervise, mentor, develop and train peers and direct report team members, when applicable
Ensure that JLL's Life Sciences Quality Management System is properly implemented and consistently met, including all ISO 9001:2015 requirements
Actively collaborate with the Life Sciences Quality Council
Any other duties and tasks as deemed necessary
QUALIFICATIONS:
BS degree in science is desired
A minimum of 8 years of experience in quality engineering, facilities design, and production/facility operations or equivalent. Strong related experience in lieu of degree may be acceptable.
Knowledge of Quality Engineering techniques such as Investigations, RCAs, CAPAs, Audit programs, Vendor Qualification, and Quality Management Systems
EIT or PE a plus
PC skills, proficient in all MSOffice applications, in particular Excel, Word, PowerPoint
Working knowledge of Quality Management Software such as TrackWise, MasterControl, Success Factors, Infinity, etc.
Oral and written communication skills including the ability communicate to all levels of management and will interface with a diverse customer base including technical and non-technical personnel
Ability to prepare and analyze technical reports for the purpose of ensuring compliance with regulations, procedures, and contractual responsibilities
Proven record of excellent internal and external customer service experience
Thorough understanding of cGxP's as they relate to the facilities, utilities, equipment, and laboratories supporting manufacturing activities of drug products
JLL Is an Equal Opportunity Employer JLL is committed to developing and maintaining a diverse workforce. JLL strongly believes in equal opportunity extended to all individuals in all aspects of the employment relationship, including recruitment, hiring, training, promotion, transfer, discipline, layoff, recall and termination without regard to race, color, religion, belief, creed, age, sex, pregnancy or maternity (including childbirth and related conditions), family responsibility (e.g. child care, elder care), nationality, ethnic or national origin or ancestry, citizenship, marital status, civil partner status, sexual orientation, gender identity or expression, transgender status, veteran’s status, genetic information, trade union membership, social position, political view or status as a qualified individual with a disability, protected leave status or any other protected characteristic in accordance with applicable law. The company also endeavors to make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodations would impose an undue hardship on the operation of our business and ensures that employment decisions are based only on valid job requirements.
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
8+ years
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