position in an exciting company.
* Active member of the R&D Quality and Compliance Clinical
management team
* Lead Clinical Compliance activities and compliance staff in one or
more therapeutic areas. Handle multiple projects and ensure overall
and timely completion of tasks.
* Works closely with compliance staff and clinical study management
teams to provide expert clinical compliance information, manage
identified issues, and support continuous improvement.
* Support deviation identification, reporting, and CAPA development
* Responsible for ensuring the development of audit strategy plan(s)
and ensuring timely execution of plans for programs.
* Oversees GCP routine and complex audits including but not limited
to investigator sites, internal processes, and vendors.
* Represent Regulatory Compliance in Working Groups as appropriate
* Supervise, develop, train and manage internal staff as
appropriate.
* Ensure oversight of contracts auditors.
* Effective compliance reporting to senior management and relevant
quality governance forums
* Leads intra/inter-departmental teams and/or projects that support
continuous improvement of the Quality Management System. Builds
positive support and acts as role model for change.
* May lead/support management of regulatory inspection activities
such as readiness preparation, inspection management, and/or response
management.
* Leads intra or interdepartmental teams of an operational nature
such as preparing the Company for minor changes in regulations,
continuous improvement initiatives.
* Fosters a commitment to quality in individuals and a culture of
quality within the organization.
* BA or BS and Significant relevant experience
* Must have significant GCP audit and compliance experience.
Clinical Quality Assurance/Compliance experience required. Bio-pharma
sponsor or CRO experience required.
* Significant experience with pediatric clinical trials strongly
preferred.
* Recognized as an expert resource on a range of clinical compliance
topics.
* Strong verbal and written communication skills and interpersonal
skills.
* Proficient in Microsoft Office suite. Experience with audit
management/CAPA management programs strongly preferred.
* Excellent organization skills and project management.
* Able to work equally well as part of a team or independently
* Ability to travel approximately **Apply on the website**%
required.
We&#**Apply on the website**;re looking for a candidate to this
position in an exciting company.
* Active member of the R&D Quality and Compliance Clinical
management team
* Lead Clinical Compliance activities and compliance staff in one or
more therapeutic areas. Handle multiple projects and ensure overall
and timely completion of tasks.
* Works closely with compliance staff and clinical study management
teams to provide expert clinical compliance information, manage
identified issues, and support continuous improvement.
* Support deviation identification, reporting, and CAPA development
* Responsible for ensuring the development of audit strategy plan(s)
and ensuring timely execution of plans for programs.
* Oversees GCP routine and complex audits including but not limited
to investigator sites, internal processes, and vendors.
* Represent Regulatory Compliance in Working Groups as appropriate
* Supervise, develop, train and manage internal staff as
appropriate.
* Ensure oversight of contracts auditors.
* Effective compliance reporting to senior management and relevant
quality governance forums
* Leads intra/inter-departmental teams and/or projects that support
continuous improvement of the Quality Management System. Builds
positive support and acts as role model for change.
* May lead/support management of regulatory inspection activities
such as readiness preparation, inspection management, and/or response
management.
* Leads intra or interdepartmental teams of an operational nature
such as preparing the Company for minor changes in regulations,
continuous improvement initiatives.
* Fosters a commitment to quality in individuals and a culture of
quality within the organization.
* BA or BS and Significant relevant experience
* Must have significant GCP audit and compliance experience.
Clinical Quality Assurance/Compliance experience required. Bio-pharma
sponsor or CRO experience required.
* Significant experience with pediatric clinical trials strongly
preferred.
* Recognized as an expert resource on a range of clinical compliance
topics.
* Strong verbal and written communication skills and interpersonal
skills.
* Proficient in Microsoft Office suite. Experience with audit
management/CAPA management programs strongly preferred.
* Excellent organization skills and project management.
* Able to work equally well as part of a team or independently
* Ability to travel approximately **Apply on the website**%
required.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
