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Associate Director, Clinical Quality Assurance

Job Description

Our client is currently looking for a Clinical Quality Assurance Associate Director who will ensure robust quality assurance systems and procedures are in place to cover our client's pre-clinical activities through clinical trial operations. The Clinical Quality Associate Director ensures non-clinical and clinical study execution are compliant with applicable GLP, GCLP, and GCP regulatory requirements. This role ensures regulatory compliance of both internal functions and outsourced activities through oversight of audit activities, utilizing internal and external resources. In this role, the Clinical Quality Associate Director effectively interfaces and collaborates with representatives from Clinical Operations, Biometrics, Clinical Development, Regulatory Affairs, and Preclinical functions.
* Develops/improves quality programs and procedures to promote, facilitate, and ensure compliance with domestic and international regulatory and industry standards and implement risk-based methodologies to improve efficiencies
* Authors and/or reviews and approves Standard Operating Procedures (SOPs)
* Reviews/approves or audits clinical and regulatory documentation and other clinical data to ensure accuracy and data integrity for GCP, GLP and GCLP activities as required
* Evaluates internal systems and external clinical sites and vendors to determine acceptable compliance to applicable regulations and guidelines. Includes but is not limited to: Clinical Investigator Sites, External CROs/Vendors, Laboratories (clinical and non-clinical), and Trial Master Files
* Provides QA support for risk assessment and remediation, and identification and investigation/CAPA of Critical Quality Issues as needed
* Oversees/approves non-clinical and clinical supplier and site audit/assessment schedules and facilitates the selection of contract auditors to support the clinical auditor program, as required and per defined budget
* Participates in or leads internal and vendor audits to ensure patient safety and data integrity
* Develops and delivers training on good clinical practice concepts and specific GCP procedures
* Represents QA at internal clinical trial team meetings
* Supports key quality processes, metrics and indicators to measure trends and improve key quality determinants of GCP and supporting GxP operations
* Effectively communicates progress and issue resolution to appropriate internal/external stakeholders
* Stays up-to-date with current regulatory changes and industry trends and translates new requirements back to the company's policies and procedures
* Facilitate/lead QA activities for GLP/GCP regulatory inspection management
* Promotes a culture of quality and operational excellence through leadership of clinical quality function and partnering with other departments throughout the organization
* Plans resources and manages staff to ensure efficient operations and encourage development of capabilities




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email [email protected] .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 

Job Snapshot

Location US-MD-Gaithersburg
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Pharmaceutical
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Company Overview

Aerotek

We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has become a leader in recruiting and staffing services by building quality relationships that allow us to place quality people in quality jobs. With more than 230 non-franchised offices, Aerotek’s 6,000 internal employees serve more than 300,000 contract employees and 17,000 clients every year. To learn more, visit Aerotek.com. Learn More

Contact Information

US-MD-Gaithersburg
Miranda Gillis
3012504347
Snapshot
Aerotek
Company:
US-MD-Gaithersburg
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Pharmaceutical
Store Type:

Job Description

Our client is currently looking for a Clinical Quality Assurance Associate Director who will ensure robust quality assurance systems and procedures are in place to cover our client's pre-clinical activities through clinical trial operations. The Clinical Quality Associate Director ensures non-clinical and clinical study execution are compliant with applicable GLP, GCLP, and GCP regulatory requirements. This role ensures regulatory compliance of both internal functions and outsourced activities through oversight of audit activities, utilizing internal and external resources. In this role, the Clinical Quality Associate Director effectively interfaces and collaborates with representatives from Clinical Operations, Biometrics, Clinical Development, Regulatory Affairs, and Preclinical functions.
* Develops/improves quality programs and procedures to promote, facilitate, and ensure compliance with domestic and international regulatory and industry standards and implement risk-based methodologies to improve efficiencies
* Authors and/or reviews and approves Standard Operating Procedures (SOPs)
* Reviews/approves or audits clinical and regulatory documentation and other clinical data to ensure accuracy and data integrity for GCP, GLP and GCLP activities as required
* Evaluates internal systems and external clinical sites and vendors to determine acceptable compliance to applicable regulations and guidelines. Includes but is not limited to: Clinical Investigator Sites, External CROs/Vendors, Laboratories (clinical and non-clinical), and Trial Master Files
* Provides QA support for risk assessment and remediation, and identification and investigation/CAPA of Critical Quality Issues as needed
* Oversees/approves non-clinical and clinical supplier and site audit/assessment schedules and facilitates the selection of contract auditors to support the clinical auditor program, as required and per defined budget
* Participates in or leads internal and vendor audits to ensure patient safety and data integrity
* Develops and delivers training on good clinical practice concepts and specific GCP procedures
* Represents QA at internal clinical trial team meetings
* Supports key quality processes, metrics and indicators to measure trends and improve key quality determinants of GCP and supporting GxP operations
* Effectively communicates progress and issue resolution to appropriate internal/external stakeholders
* Stays up-to-date with current regulatory changes and industry trends and translates new requirements back to the company's policies and procedures
* Facilitate/lead QA activities for GLP/GCP regulatory inspection management
* Promotes a culture of quality and operational excellence through leadership of clinical quality function and partnering with other departments throughout the organization
* Plans resources and manages staff to ensure efficient operations and encourage development of capabilities




About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.



The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email [email protected] .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.

Job Requirements

 
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