AbbVie
Ludwigshafen, Germany
Description
PRIMARY JOB FUNCTION:
A robust clinical quality assurance program supports AbbVie fulfilling its responsibilities as a sponsor of clinical trials and achieving its quality objectives in clinical research. The value of quality assurance is demonstrated in confidence in data quality and integrity as well as protection of human research subjects, enabling marketing authorizations and getting important new therapies to patients faster. This is accomplished through proactive consultation with R&D functions involved in clinical development as well as through assessment and audit. This role provides leadership for the AbbVie GCP audit program, advises on GCP compliance matters, and contributes to continuous improvement projects. The Associate Directors leads and develops personnel in the R&D GCP Quality Organization and advances the AbbVie R&D quality management system to ensure effective and sustainable quality support of AbbVie’s dynamic development pipeline.
CORE JOB RESPONSIBILITIES:
- Responsible for compliance with applicable Corporate Policies and procedures;
- Leadership and oversight of the GCP quality assurance program including investigator site audits and internal system audits per assigned areas of responsibility, including leading audits are certain assessment activities;
- Developing and contributing to quality strategies;
- Management oversight of complex programs; Leads goals with cross functional/cross divisional projects;
- Management responsibility to resolve and/or elevate issues as appropriate;
- Providing consultation and direction on complex quality assurance and GCP compliance questions from supported organizations;
- Resolves project team issues with minimal oversight;
- Influence process improvement initiatives;
- Remaining abreast of current health authority expectations and incorporate into quality assurance deliverables;
- Strategic planning to ensure resources are available to support plans;
- Provide support for regulatory Inspections (internal and external), corrective actions, responses and follow-up. Provides consultation on issue resolution in these areas;
- Executing AbbVie quality system processes including those for CAPA, issue escalation, change management, documentation, and personnel qualification;
- Development and support of staff to ensure high skill level and promote growth and development in alignment with departmental and personal growth objectives.
Must be willing and able to travel 25% of the time to domestic and international locations.
POSITION ACCOUNTABILITY/SCOPE:
This position is accountable to the Sr. Director, R&D Clinical and Pharmacovigilance Quality Assurance. The decisions and recommendations made by the individual will directly impact compliance to applicable regulations and guidelines (i.e. GCP, ICH, etc.), and thereby promote the continued success of AbbVie R&D. The activities such as auditing and associated functions can have a significant impact on the quality of the data. Failure to appropriately identify compliance risks can have a significant negative impact on the quality of the data that can, ultimately, lead to delay or inability of AbbVie to release or present quality data to regulatory authorities which can delay approval and marketing authorization of new and/or existing products.
This position directly manages R&D GCP QA staff based in Europe and works with other global team members, many based in the corporate headquarters in North Chicago, Illinois, USA. The Associate Director has frequent interactions with QA management, and cross-functional leadership at all levels. The individual in this role must operate independently with autonomy and limited supervision. This role directly leads R&D GCP QA staff supporting multiple therapeutic areas and responsible for supervision, performance management, and professional development,. The Director provides guidance to all levels of management related to quality and compliance including: audits, corrective action plans, and consulting on compliance matters. The Associate Director leads and contributes to continuous improvement initiatives.
Identifies and resolve issues through effective use of technical and interpersonal skills leveraging applicable quality systems elements. Demonstrates decision-making ability with limited management supervision and is a responsible authority on ethical and quality issues and will require minimal supervision when dealing with other functions.
Qualifications
EDUCATION:
- Bachelor’s degree preferably in a Physical Science, Life Science, Pharmacy, Engineering or equivalent experience required.
- Position Titles or Description of Experience Years:
- 5 years experience in GCP audit (strongly preferred), clinical operations, or clinical compliance functions;
- 5 years experience in pharmaceutical industry;
- 5 years experience as a manager/superisor.
MINIMUM EXPERIENCE/TRAINING REQUIRED:
- Minimum of 10 years total combined experience required.
OTHER REQUIREMENTS
- Thorough, documented understanding/knowledge of international GxP requirements, especially in GCP. Knowledge of the clinical development processes for pharmaceuticals and/or medical devices.
- Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results, as well as to meet or exceed customer expectations.
- Expertise in Quality Management Systems (QMS) and Quality Risk Management (QRM).
- Demonstrated ability in strategic planning and cross functional execution.
- Strong understanding of global Pharma, clinical operations, legal and regulatory environments.
- Experience in preparing/presenting key information to senior level management.
- Personnel management/supervision experience.
- Requires problem solving abilities at both strategic and operational levels. To identify and resolve issues related to quality and compliance with global and local regulations, polices, and procedures. This involves both internal cross-functional problem solving as well as issue resolution between functional areas and external collaborators.