- Degree in Science, Nursing, or related field.
- Strong knowledge of GCPs, ICH guidelines and FDA regulations related to Clinical Research, and experience in Clinical Quality Assurance.
- Working knowledge of the drug development process, GLPs, and GMPs.
- Knowledge of ISO 27001 helpful.
- Knowledge of 21 CFR Part 11 and computer system validation.
- Computer literate in Microsoft Office, Word, Excel, and Power Point.
- Excellent organizational, communication, writing and time management skills.
- Minimum of five (5) years of clinical research experience in a CRO pharmaceutical, biotech, medical device and other life science industries or equivalent education and experience
- Conducts independent internal quality review of studies performed and ensures the conduct of clinical systems audits are performed per audit plan
- Oversees and advises on the development of Standard Operating Procedures (SOPs), Guidelines and other tools.
- Performs external non-Frontage investigational sites audits (as needed) for compliance with GCPs and ICH guidelines, applicable FDA regulations, SOPs, and the study protocol.
- Hosts regulatory agency inspections/sponsor audits and issues responses to audit report findings after discussion with operations management.
- Works with quality team and management to ensure internal and external audit findings are addressed, deficiencies are corrected, and preventive actions are implemented.
- Leads study conduct investigations and non-conformance issues. Develops, recommends, and monitors Corrective and Preventive Action Plans (CAPAs). Performs effectiveness verification to ensure CAPAs were implemented.
- Tracks and trends audit findings, investigations, assesses compliance risk and escalates to site management appropriately.
- Initiates and manages quality metrics and trending analysis and presents findings to management appropriately.
- Updates department management on new/updated regulations affecting CRC operations and provides training as appropriate to ensure ongoing compliance with current quality and industry regulatory requirements.
- Reviews and approves computer systems validation (CSV) documents (when applicable) to ensure compliance with internal procedures and regulatory requirements.
- Evaluates procedures and processes affecting quality and proposes process improvement initiatives.
- Represents clinical Quality Assurance as a management representative for the development of company policies and procedures.
- Other responsibilities as may be assigned.
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Clinical QA Manager - Secaucus, United States - Frontage Laboratories
Description
Job Description
Job DescriptionClinical QA Manager
Location: Secaucus, NJ
Full-time
Reports to: President, Frontage Clinical Services administratively, James Huang, VP, Corporate QA functionally
Duties: Responsible for the quality management of a Phase I/IIA Clinical Research Center (CRC), Data Management and Biostatistics groups at Frontage Clinical Services, Inc.
Works with the Operations and Management teams to design and implement a robust quality system to comply with GCP regulations and standards.
Independent oversight of the GCP quality systems achieved by performing planned systematic actions to ensure that activities performed comply with applicable laws and regulations, and that study protocols are being followed using approved operating procedures.
Domestic travel may be required.
Report quality and compliance key performance indicators (KPI) to Frontage lab clinical services and corporate management for proactive action and drive continuous improvement.
Qualifications:
Experience:
Specific Responsibilities:
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
