Abbott India Limited is a subsidiary of Abbott Laboratories, USA, a global, diversified health care company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company now employs approximately 70,000 people and markets its products in 130 countries worldwide.
Post: GCP QA, Therapeutic Area Lead
Job Description:
DEPARTMENT FUNCTION/OBJECTIVE:
Through partnerships with GPRD, GCP QA Operations is responsible for ensuring high quality clinical trials which are performed in compliance with worldwide regulatory expectations. The ultimate product would be regulatory submissions which demonstrate good scientific rationale and interpretation plus inscrutable data integrity. The goal of the department is appropriate protection of all human subjects participating in clinical trials utilizing Abbott product.
PRIMARY FUNCTION:
1. Management of all quality-related activities to deliver consistent, high quality clinical studies, documents, and clinical program activities for GPRD and affiliates.
2. Assure that GPRD remains in compliance with Corporate and Divisional policies and procedures and all applicable worldwide regulations.
3. Participate in internal GCP auditing programs for the designated therapeutic area in the GPRD organization.
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.
5. Partner with the business to help create strategies to respond to regulatory deficiencies (e.g. FD 483) and other requests from regulatory authorities.
6. Provide GPRD personnel with training on applicable worldwide regulations which impact clinical development.
7. Implement risk management as an integral part of Abbott’s approach to GCP compliance. Ensure all risks (and impact of those risks) are communicated effectively to business partners.
8. Consult with GPT’s as an SME for the designated therapeutic area.
9. Lead cross-functional project teams to help resolve issues and to drive process improvements.
10. Lead by example.
MAJOR DUTIES & RESPONSIBILITIES:
• As required, participate in GCP QA Operations auditing program to assure global compliance of GPRD operations (including Abbott Affiliates) with Corporate and Divisional policies and procedures and all applicable worldwide regulations
• Drive clinical development program implementation via roles on the Global Project Team, Clinical subteam or other GPT subteams in the designated therapeutic area(s) as needed to proactively avoid, manage or address quality-related issues.
• Participate in independent QA reviews of documents slated for submission to regulatory authorities (e.g. Investigator Brochures, Labeling, Protocols / Amendments, Study Reports/ Summaries, etc.)
• Independent evaluation of Phase I – IV study conduct via routine audit program evaluating the performance of investigators, field monitors, Contract Research Organizations, central Investigational Review Boards, testing laboratories, and study management on a global basis.
• Provide support for regulatory inspections (internal and external), corrective actions, responses and follow-up. Provides consultation on issue resolution in these areas.
• Provide internal and external training on relevant regulations and quality systems/processes to aid in the development of uniform standards.
• Serve as consult for Division Institutional Review Board functions and Affiliate inquiries on quality related issues.
• Generate, analyze and report quality metrics relating to the conduct of clinical studies and Affiliate activities
• Provide expert input and advice, review and approve quality system documents including SOPs, guidelines and work instructions impacting clinical trial activities.
• Responsible for the implementation, development and maintenance of an audit tracking and trending system including process mapping, form development, audit report structure and trend report content and design
• Drive the concept of risk management and implement a risk management program within GCP QA Operations.
• Drive continual process improvement based on appropriate metrics and key performance indicators (KPIs).
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PROBLEM SOLVING:
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.
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The individual must be able to:
• Translate strategic initiatives into tactical processes in a GCP QA Operations environment divided by therapeutic area.
• Manage cross-functional teams and projects in multiple global locations simultaneously.
• Function as the primary point of contact for all clients in their therapeutic area of responsibility including: audits, corrective action plans, and consulting.
• Successfully interact with all levels of personnel within the division.
• Interpret the global regulations and apply quality principles to solve problems in a research and development environment.
• Identify potential compliance gaps
• Take initiative and identify new approaches to resolve problems (i.e., risk assessments, CAPA plans) and mitigate risks.
• Successfully translate new regulations into workable processes and train the business on those processes.
ACCOUNTABILITY:
This position is accountable to the Associate Director of GCP QA Operations. The decisions and recommendations made by the incumbent will directly impact future compliance to applicable regulations and guidelines (i.e. GCP, ICH, etc.) and thus the continued success of GPRD. These activities such as auditing and associated functions can have a significant impact on the quality of the data that can, ultimately, lead to delay or inability of Abbott to release or present quality data to regulatory authorities which will delay approval and marketing rights of new and/or existing products.
Individual will be the primary point of contact for all clients (domestic and international) in their areas of responsibility for including: audits, corrective action plans, and consulting.
SCOPE OF AUTHORITY:
This is an experienced level Operations position, the incumbent reports to the Associate Director – GCP QA Operations. The incumbent is expected to identify and resolve problems through effective use of technical and interpersonal skills. The incumbent must be an effective team leader. The incumbent is expected to demonstrate decision-making ability with limited management supervision. The incumbent is recognized as a responsible authority on ethical and quality issues and will require minimal supervision when dealing with division functions. Appropriate management consultation should be sought when policy decisions are involved having a major impact to the division and/or corporation. Limits to freedom and individual action by the incumbent are based on the level of expertise and interpersonal skills possessed.
Assignments will involve interacting with GPRD clients, all levels of GPRD management, and external Contract Research Organizations/Laboratories.
Desired Profile:
Quality Assurance/Regulatory Affairs:
• 5-7 years in a Compliance, Clinical Operations or GCP Auditing Function
• 5-10 years in Quality Assurance
Pharmaceutical Industry:
• 7-10 years GXP regulated function
Bachelor's Degree in physical science, life science, nursing or pharmacy or equivalent experience; Master's Degree preferred.
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Additional Information:
Experience: 5-10 Years
Location: Lake County, IL
Education: B.Pharm, M.Pharm, BS, MS
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA, DRA
Keyword or Job ID: 94867BR
End Date: 10th Sept., 2011
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