job title gcp qa, therapeutic area lead
job family quality assurance
job category full-time
job classification experienced/established
division global pharmaceutical r and d
relocation assistance none
at abbott, we provide the perspectives and experience necessary to translate science into real solutions for patients in over 130 markets worldwide. the decisions and recommendations made by the incubment will directly imapct future compilance to applicable regulations and guidleines (i.participate in gcp qa opertaions auditing program to assure global compliance of gprd operations (inclduing abbott affiliates) with corporate and divisional policies and procedures and all applicable worlwdide regulations
, as required.
. proivde internal and external training on relevant regulations and quailty systems/processes to aid in the development of uniform standards.
10. lead by example.
1. limits to freedom and individual action by the incumbent are based on the level of expertise and interpersonal skills possessed.
. provide support for regualtory inspections (internal and external), corrective actions, responses and follow-up.drive the concept of risk management and implement a risk management program within gcp qa operations.g. fd 483) and other requests from regulatory authorities.the incumbent is recognized as a resposnible authority on ethical and quailty issues and will require minimal supervision when dealing with division functions. all levels of gprd management,
assignments will involve interacting with gprd clients, and external contract research organizations/laboratories.innovative thinkers who are passionate about the work they do, abbott employees are representative of the diversity of the patients we strive to serve every single day across the globe.
5. partner with the busniess to help create strategies to respond to regulatory deficiencies (e.) and thus the continued success of gprd. corrective action plans,
. function as the primary point of contact for all clients in their therapeutic area of responsibility inclduing: audits, and consulting.drive cliincal development program implementation via roles on the global proejct team, cliincal subteam or other gpt subteams in the designated therapeutic area(s) as needed to proactively avoid, manage or address quailty-related issues.corrective action plans, and consulting,
individual will be the primary point of contact for all clients (domestic and international) in their areas of responsibility for including: audits.analyze and report quality metrics relating to the conduct of clinical studies and affiliate actiivties
. generate.lead to delay or inability of abbott to release or present quality data to regulatory authorities whcih will delay approval and marketing rights of new and/or existing products, ultimately, these activities such as auditing and associated functions can have a significant impact on the quality of the data that can.
. successfully interact with all levels of personnel within the division.through our diverse healthcare businesses, we connect people and potential in ways that no other company can.provides consultation on issue resolution in these areas.
6. provide gprd personnel with training on applicable worldwide regulations which impact clinical development.take initiative and identify new approaches to resolve problems (i.
2. assure that gprd remains in compliance with corporate and divisional policies and procedures and all applicable worldwide regulations.the goal of the depatrment is appropriate protection of all human subjects participating in clinical trails utilizing abbott product.
7. implement risk management as an integral part of abbott\'s approach to gcp compliance.
major duties & responsibilities:
. today, abbott\'s nearly 90, 000 employees are doing work that matters.protocols / amendments, study reports/ summaries, etc, labeling, g. investigator brochures.
. responsible for the implementation, form development, audit report structure and trend report content and design
, development and maintenance of an audit tracking and trending sytsem including proecss mapipng.5-10 yeras in quality assuarnce
. the incumbent must be an effetcive team ledaer. provide exeprt inupt and adivce, guidelines and work instrcutions impatcing clinical trail activities, reivew and apporve quality sytsem docuemnts including sops.enusre all rikss (and impact of thsoe rikss) are commuincated effecitvely to business parnters.
job descrpition department function/objetcive:
thorugh partnreships with gprd, gcp qa operations is responsible for ensruing high quality clinical trials which are perfromed in compliance with worldwide regulatory expecattions.
9. lead crsos-funcitonal project teams to help resolve issues and to drive process improvements.clinical operations or gcp auditing function
, 5-7 years in a compliance.
scope of authority:
this is an experienced level operations position, the incumbent reports to the associate director - gcp qa operations. we believe that diversity drives innovation,
eeo statement:at abbott.high quality clinical studies, documents, and clinical program activities for gprd and affiliates, management of all quality-related activities to deliver consistent.
. drive continual process improvement based on appropriate metrics and key performance indicators (kpis).
skills/experience requirements quality assurance/regulatory affairs:
the job requires knowledge of quality principles, research, and the development of pharmaceuticals and an understanding of the effect of his/her decisions on it.etc, e. gcp, ich.the incumbent is expected to demonstrate decision-making ability with limited management supervision. the incumbent is expected to identify and resolve problems through effective use of technical and interpersonal skills.
. interpret the global regulations and apply quality principles to solve problems in a research and development environment.
8. consult with gpt\'s as an sme for the designated therapeutic area.
4. provide consultation and assistance to both domestic and international gprd personnel on internal and external audit findings, compliance issues, regulatory risks, and process improvement opportunities.
discover a world of opportunities at abbott.)
. independent evaluation of phase i - iv study conduct via routine audit program evaluating the performance of investigators, central investigational review boards, and study management on a global basis, contract research organizations, field monitors, testing laboratories.nursing or pharmacy or equivalent experience; master\'s degree preferred, life science, 7-10 years gxp regulated function
education requirements bachelor\'s degree in physical science.
. participate in independent qa reviews of documents slated for submission to regulatory authorities (e.
this position is accountable to the associate director of gcp qa operations.
. manage cross-functional teams and projects in multiple global locations simultaneously.
significant work activities & conditions continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
percent of travel 0 - 20 %
country united states
site location lake county, abbott is regarded as an employer of choice for our commitment to workplace excellence, il
employer of choice
through numerous local, national and international accolades.risk assessments, capa plans) and mitigate risks, e. translate strategic initiatives into tactical processes in a gcp qa operations environment divided by therapeutic area.our employees are given the tools to succeed, with challenging opportunities and work that makes a difference, lead and grow.
3. participate in internal gcp auditing programs for the designated therapeutic area in the gprd organization.the ultimate product would be regulatory submissions which demonstrate good scientific rationale and interpretation plus inscrutable data integrity.
. successfully translate new regulations into workable processes and train the business on those processes.
. serve as consult for division institutional review board functions and affiliate inquiries on quality related issues.
the individual must be able to:
. appropriate management consultation should be sought when policy decisions are involved having a major impact to the division and/or corporation.
. identify potential compliance gaps