Job Summary
The Associate Director - GCP manages and coordinates GCP regulated QA activities.
This individual is responsible for performing domestic and international audits/inspections that ensure compliance with the FDA and other worldwide health authority regulations/guidelines, site SOPs, protocols, and industry standards, as applicable. The Assistant Director GCP acts as a compliance resource to associates and provides recommendations for corrective action and tracks corrective action commitments until closure.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.
Plans and conducts document, internal and external GCP audits of clinical research activities to assess compliance with FDA and ICH GCP, and local regulations, as well as with protocol and company SOPs .Conducts routine reviews of documentation including but not limited to protocols, case report forms, tables and listings, investigator brochures, informed consent forms and clinical study reports.
Audits and evaluates service providers (e.g. clinical investigational sites, CROs, vendors), as appropriate, to assess capabilities and compliance with applicable regulations as well as with company policies and procedures.
Works closely with Clinical Operations staff and Service Providers to identify, evaluate, and recommend solutions to issues identified in the performance of GCP audits.
Prepares clear and concise written reports of audit observations, including an assessment of compliance.
Evaluates responses and corrective and preventive action plans to audit findings for adequacy and timeliness and manage the closeout of all corrective and preventive actions.
Develops and oversees audit plans for each clinical study.
Maintains Quality documentation files, databases and logs. Tracks metrics and trends as well as compliance issues and their resolution.
Assists with GCP training internally and where required externally of investigators and service providers.
Works with the Head of Quality to assure alignment and compliance with Quality Management System, support assessment of compliance and define metrics to determine performance objectives.
Reviews internal and external SOPs. Participates in the development of departmental SOPs, as appropriate.
Acts as a key point of contact for staff, providing information and expert guidance on regulations and procedures related to GxP and Quality to associates.
May be responsible for training and mentoring associates on the Quality team.
Provides support during compliance inspections conducted by external sources (i.e. health authorities).
Education and/or Experience:
Bachelors degree in a scientific or health-related field is required.
Masters degree in a scientific or health- related field is preferred.
Minimum of seven to nine years in the life science industry experience required.
Minimum of five years Quality auditing experience in the biotechnology or pharmaceutical industries required.
Prior supervisory experience preferred.
Qualifications:
Professional expertise and knowledge of local and international GxP regulations required.
Expert knowledge of GCPs, FDA regulations and ICH guidelines is required. Extensive knowledge of EMA requirements desired.
Must be able to interpret and apply GCP regulations and guidances, including 21CFR part 11 requirements.
Maintains professional expertise and knowledge of local and international regulations related to Quality and GCP.
Computer Skills:
Must be proficient in MS Office Suite.
Strong knowledge of and ability to navigate Health Authority Websites (e.g. FDA, EMA, ICH).
Other Skills and Abilities:
Excellent verbal and written, communication and presentation skills.
Excellent organizational skills and attention to detail are essential.
Ability to interact effectively with all levels of associates both internally and externally including investigators and study site personnel.
Ability to review documentation, processes and procedures as it relates to clinical trial activities; to identify issues/problem areas; assess compliance; communicate findings to the clinical teams.
Ability to prioritize and multi-task successfully in a fast paced environment.
Ability to work both independently and in a collaborative team setting.
Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate
Proven ability to manage projects, teams or personnel of significant scope and complexity, while meeting deliverables and timelines.
Demonstrated leadership and project management skills.
This position requires travel; average travel for this position is 15-25% with some variation based upon the demands of the business imperatives. Travel is both domestic and international for the purpose of auditing GCP related activities.
POSITION NOTE: Please login to your Virtual Vocations account to view the company information and application instructions
