Description: Our client is currently seeking a Sr. Manager/Associate Director, Clinical Quality Assurance .
- Manage/provide oversight or conduct GCP/GLP/PV (internal, vendor and clinical sites) on site as well as remote audits
- Identify the need for conduct of various audits (including clinical sites, central IRBs, vendors and PV partners, etc.)
- Manage contract auditors in the scheduling process, kick-off meetings with contract auditors and internal functional groups, assist in the drafting of audit agendas, confirmation letters etc. as needed
- Oversee the audit response process for the various audits, regulatory inspections and ensure acceptability of actions to address findings through the CAPA process as applicable
- Work closely with different functional groups to ensure/coordinate appropriate resolution of audit findings, non-compliance issues, investigations, etc. in a timely manner, including review and approval of CAPA plans, as applicable
- Work directly with CROs and other external contractors and collaborators, managing the chain of communication related to GCP compliance
- Perform program specific root cause analysis of compliance issues and provide the appropriate metrics for tracking and trending for the overall QA reporting requirements to functional and senior management
- Draft, and revise company SOPs to assess their adequacy and compliance with industry and regulatory requirements
- Attend cross-functional team meetings, provide guidance to different functional groups (including clinical and PV), based on interpretation of current regulations to ensure best practices including risk-based approach
- Assist in preparation and support of regulatory GCP/GPV inspections, prepare, and conduct Pre-Approval Inspection (PAI) activities as needed
- Escalate issues of critical non-compliance and/or lack of urgency in remediation to senior management via the Quality Board
- Provide QA review of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, Investigator Brochures and other relevant documents
- Provide and/or assist in periodic GCP training to the internal and external company staff as necessary
- Assist in preparing and managing departmental budget.
- At least 8-10 years of direct GCP pharmaceutical/biotechnology experience
- Solid understanding and application of GCP, GLP and ICH E6R2 requirements. Good working knowledge of GPV guidelines
- Ideal candidate will have broad experience in product development, support of clinical operations, field GCP auditing and regulatory inspection support.
- A well organized, self-motivated and independent work style with the ability to initiate and follow through on assignments
- Excellent interpersonal and conflict management skills to assure effective interactions within and across departments
- The ability to simultaneously handle multiple project issues while dealing with time demands, ability to provide a solution-based approach to emerging challenges
- A strong team player is required with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations & business needs
- Proven track-record of leadership & building relationships with both internal & external customers
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
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