Location: REMOTE 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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According to the US Bureau of Labor Statistics (BLS), employment in computer and information technology occupations is projected to grow 11 percent from 2019 to 2029, much faster than the average for all occupations. These occupations are projected to add about 531,200 new jobs. Demand for these workers will stem from greater emphasis on cloud computing, the collection and storage of big data, and information security.
According to BLS, the median annual wage for computer and information technology occupations was $91,250 in May 2020, which was higher than the median annual wage for all occupations of $41,950.