Judge Technical Staffing seeks a Senior Manager Clinical Quality Assurance and Quality Systems for a biotechnology client.
This is a temporary to possible permanent opportunity.
The Senior Manager of Clinical Quality Assurance and Quality Systems is responsible for developing and overseeing administration of clinical quality assurance activities including, but not limited to surveillance (e.g., process, system and record audits) and, review and approval of documents associated with clinical strategy development/deployment and operations (plans, protocols, CRF, CSR, ISE, ISS, etc.).
*The Senior Manager oversees all internal and external audits associated with clinical operations to assure compliance with GCP and corporate policies and procedures.
*The Senior Manager will serve as the primary Quality Assurance interface with internal and external customers and partners involved in the development, execution and surveillance of clinical programs.
* This position will serve as Subject Matter Expert with respect to Clinical Quality Assurance and in this capacity is responsible for providing professional guidance and leadership to ensure policies, processes and procedures comply regulatory and industry best-practices.
*Responsibilities will also include oversight and development of GxP training programs for the company.
*Additionally, there will be responsibilities for developing, deploying and maintaining policies, procedures and guidelines encompassing quality systems supporting Good Manufacturing Practices (GMP) and manufacturing and quality operations as assigned.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Manage Clinical Quality Assurance (CQA) staff (permanent and temporary, when applicable)
• Train CQA staff (permanent and temporary, when applicable).
•Assure that processes, procedures and activities are in compliance with industry standards, GCPs and other current Regulations and Guidances.
• Investigate and resolve compliance problems and questions regarding Regulatory Affairs, Clinical Operations, Drug Safety, Data Management, Biometrics, Risk Management and Medical Affairs.
•Facilitate/organize interdepartmental meetings with Drug Safety, Regulatory Affairs and other departments to maintain awareness of pertinent issues and to provide quality-related perspective while promoting thorough communication across departments as needed.
•Organize and /or chair committees related to CQA/Compliance issues, as needed.
• Develop and maintain policies, Standard Operating Procedures (SOPs) and Work Practices (WPs) in compliance with regulatory and industry standards and policies and procedures.
•Perform internal and external compliance audits (e.g., GxP) in accordance with audit plans, applicable regulations and QA SOPs. Internal audits include, but are not limited to, compliance with policies and procedures, databases, clinical study reports, safety summaries, data, tables, listings and any high level documents (includes but is not limited to Integrated Reports, Protocols, Investigators’ Brochures, Statistical Analysis Plans etc…)
•Prepare and issue detailed audit reports to appropriate personnel outlining compliance issues noted during audits/inspections. Support preparation and deployment of associated CAPA plans as well as follow-up to assess progress and verify effectiveness of such plans.
•Participate in site Regulatory Agency Inspections as business needs dictate in accordance with SOPs
•Assist in the preparation of responses to Regulatory Agency requests when appropriate and conduct quality audits of the data as needed
•Ensure the quality of internal/external documents (Case Report Forms, Document Completion Guidelines, Protocols, etc…) and/or approve the documents in accordance with internal procedures
•Responsible for developing and maintaining training requirements and procedures for GxP operations. This includes ensuring that the training needs of employees are identified, training methods/tools are established and deployed, and training records are maintained.
•Conduct quality system failure investigations as business needs dictate and report to management
•Complete other applicable duties, as business needs dictate a and as directed by Senior Management
EDUCATIONAL REQUIREMENTS (degree, license, certification):
•At a minimum, bachelor’s degree in relevant life science (i.e. Nursing, Biology) is required.
YEARS OF EXPERIENCE:
•At a minimum, 6 years of experience in clinical compliance areas and/or auditing in GXP compliance in the pharmaceutical industry with at least 3 years direct managerial responsibility.
•Work experience as a Clinical Trial Monitor or experience in the regulatory approval process.
•Thorough knowledge of GCP, GMP, 21 CFR Part 11 regulations and ICH guidelines is required.
•Excellent leadership skills with a proven record of leading and motivating a dynamic group of skilled professionals and excellent interpersonal and verbal/written communication skills.
•Good organizational, project management and influencing skills.
•This person must be a collaborative team player with a can-do attitude, the ability to think and implement quickly, and identify creative solutions to complex technical problems.
Please contact:
Deirdre Middleton
1-888-228-7162 x1581
610-667-7700 x1581
dmiddleton@judge.com
