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Posted : Thursday, October 05, 2023 10:18 AM
*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 Job Type: Full-time Pay: $130,000.
00 - $170,000.
00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Health insurance * Life insurance * Paid time off * Vision insurance Schedule: * Monday to Friday Education: * Bachelor's (Required) Experience: * Quality and Compliance: 8 years (Required) Willingness to travel: * 50% (Required) Work Location: Remote
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 Job Type: Full-time Pay: $130,000.
00 - $170,000.
00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Health insurance * Life insurance * Paid time off * Vision insurance Schedule: * Monday to Friday Education: * Bachelor's (Required) Experience: * Quality and Compliance: 8 years (Required) Willingness to travel: * 50% (Required) Work Location: Remote
• Phone : NA
• Location : Remote
• Post ID: 9132485827
