Quality Assurance 20231-MZ
Manager, QA GCP
This position performs and manages an audit schedule that will assure company clinical studies (Phase I through IV) are compliant with regulatory requirements. This position interacts with QA functional and cross-functional teams, communicates with QA consultants, and has contact with external auditees, e.g., vendors, partners, and affiliates. Duties of this role include supporting all aspects of GCP and GLP regulatory inspections internally at company facilities as well as externally at clinical investigator sites. Additionally, this level collaborates on local and global QA GCP objectives, authors procedural documents, and provides training to clinical study teams on regulatory requirements. This position provides consultation on procedural and study related queries and escalates issues of elevated risk to senior management. The majority of decisions are based on the interpretation of established guidelines, regulations, and company procedural documents which requires problem solving skills. This position will have strategic direction provided and tasks assigned by level IV management. Based on business need, position may carry out tasks of QA GCP-GLP level (I).
Performs and manages all types of audits in the clinical studies audit program. It also includes the auditing schedule of clinical investigator sites (phases I to IV), GCP internal systems.
Verifies, assesses, and tracks CAPA documentation and commitment implementation. Evaluates impact of CAPA implementation when appropriate. Generates requests and reminds relevant parties of follow-ups.
Interprets relevant regulations and applies these to practical Clinical Research and Development programs. Supports intelligence collection, communicates, and presents findings on relevant topics for training.
Supports GCP/GLP regulatory inspections (internal) at company facilities, investigator sites, CROs, and bio-analytical laboratories for US submissions and investigator sites. Prepares, coordinates, and tracks document requests, responses, and supporting documentation during inspections, and verifies implementation of responses after inspections.
Drafts QA policies, procedures, and standards. Tracks and manages the review process of specific global and local QA SOPs and Collaborates with global QA teams in developing and implementing GCP/GLP QA objectives and schedules for audits of investigator sites, CROs, bio-analytical labs, etc. Based on risk considerations, elevates issues to senior management.
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