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Compliance Program Manager Usona Institute

Location
Madison, WI

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Job Description
JOB OBJECTIVE:
The Compliance Program Manager is responsible for developing and maintaining a compliance program including strategies and activities in accordance with relevant regulatory and legal guidelines and requirements (CFR 21, GCP, ICH E6 etc). This role will work in collaboration with the Program Lead, Director of Operations, Project Leads and Teams to develop, operationalize, and communicate policies, processes and procedures. The Compliance Program Manager must be detail-oriented and have the ability to identify and mitigate potential risks to the Clinical Research Team and wider organization as appropriate.
ESSENTIAL DUTIES:
1. Holds primary responsibility for the development and management of the Usona quality management systems, including clinical and regulatory Standard Operating Procedure (SOP) and Work Instruction (WI) creation and continuous improvement. Ensures that comprehensive and consistent policies/procedures are established and maintained.
2. Acts as primary administrator of Usona’s electronic quality management system, including document control and employee training.
3. Leads and supports periodic review of documents, revising them as appropriate in collaboration with relevant Project Teams.
4. Ensures that forms and template documents are consistent with relevant SOPs and WIs.
5. Works with Program Lead to develop and implement risk mitigation plans for program projects and activities.
6. Monitors and tracks ongoing Usona SOP compliance and deviations, and develops Corrective and Preventive Actions (CAPAs).
7. Manages employee training and ensures training logs, job descriptions, org charts, and CVs are up-to-date (including GCP and HIPAA training for clinical trials personnel).
8. Acts as point contact for audits within the Clinical Research Team and wider organization.
9. Oversees eTMF compliance (in collaboration with CRO) through periodic reviews.
10. Ensures real time Sponsor inspection readiness, and supports CRO with clinical site inspection readiness.
11. Acts as GCP and clinical operations subject matter expert to provide internal guidance on regulatory and legal requirements.
12. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
OCCASIONAL DUTIES:
1. Performs SOP gap analyses for vendors as appropriate, including CROs.
2. CRO clinical operations team qualification/verification.
3. Collation and write up of historical activities.
4. Performs study protocol working files management (in collaboration with Clinical Trial Associate).
MANDATORY QUALIFICATIONS:
1. Bachelor’s degree, preferably in the life sciences.
2. At least 7 years of clinical compliance, operations and/or quality, preferably in a clinical research setting.
3. Detailed knowledge of relevant regulations, standards, and best practices (CFR 21, GCP, ICH E6 etc.).
4. Ability to think critically and independently and to exercise sound judgment toward the resolution of issues.
5. Independent, self-starter with proven results in problem identification, planning, communication and project
management.
PREFERRED QUALIFICATIONS:
1. Proficiency with Microsoft Word, Excel, and Outlook.
2. Experience developing or managing quality systems.
PHYSICAL REQUIREMENTS:
1. Ability to use computer equipment.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.
The Compliance Program Manager is responsible for developing and maintaining a compliance program including strategies and activities in accordance with relevant regulatory and legal guidelines and requirements (CFR 21, GCP, ICH E6 etc). This role will work in collaboration with the Program Lead, Director of Operations, Project Leads and Teams to develop, operationalize, and communicate policies, processes and procedures. The Compliance Program Manager must be detail-oriented and have the ability to identify and mitigate potential risks to the Clinical Research Team and wider organization as appropriate.
ESSENTIAL DUTIES:
1. Holds primary responsibility for the development and management of the Usona quality management systems, including clinical and regulatory Standard Operating Procedure (SOP) and Work Instruction (WI) creation and continuous improvement. Ensures that comprehensive and consistent policies/procedures are established and maintained.
2. Acts as primary administrator of Usona’s electronic quality management system, including document control and employee training.
3. Leads and supports periodic review of documents, revising them as appropriate in collaboration with relevant Project Teams.
4. Ensures that forms and template documents are consistent with relevant SOPs and WIs.
5. Works with Program Lead to develop and implement risk mitigation plans for program projects and activities.
6. Monitors and tracks ongoing Usona SOP compliance and deviations, and develops Corrective and Preventive Actions (CAPAs).
7. Manages employee training and ensures training logs, job descriptions, org charts, and CVs are up-to-date (including GCP and HIPAA training for clinical trials personnel).
8. Acts as point contact for audits within the Clinical Research Team and wider organization.
9. Oversees eTMF compliance (in collaboration with CRO) through periodic reviews.
10. Ensures real time Sponsor inspection readiness, and supports CRO with clinical site inspection readiness.
11. Acts as GCP and clinical operations subject matter expert to provide internal guidance on regulatory and legal requirements.
12. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
OCCASIONAL DUTIES:
1. Performs SOP gap analyses for vendors as appropriate, including CROs.
2. CRO clinical operations team qualification/verification.
3. Collation and write up of historical activities.
4. Performs study protocol working files management (in collaboration with Clinical Trial Associate).
MANDATORY QUALIFICATIONS:
1. Bachelor’s degree, preferably in the life sciences.
2. At least 7 years of clinical compliance, operations and/or quality, preferably in a clinical research setting.
3. Detailed knowledge of relevant regulations, standards, and best practices (CFR 21, GCP, ICH E6 etc.).
4. Ability to think critically and independently and to exercise sound judgment toward the resolution of issues.
5. Independent, self-starter with proven results in problem identification, planning, communication and project management.
PREFERRED QUALIFICATIONS:
1. Proficiency with Microsoft Word, Excel, and Outlook.
2. Experience developing or managing quality systems.
PHYSICAL REQUIREMENTS:
1. Ability to use computer equipment.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.
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