Sr Mgr, Post Market Quality
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Job Location:
Heredia - Costa Rica
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Purpose: Individual will lead the Global Complaint team which processes medical device or pharmaceutical combination product complaints and inquiries. Will manage complaints from both the Legacy AbbVie and Legacy Allergan portfolios in a global capacity. Interface with internal and external AbbVie customers such as physicians nurses pharmacists hospital personnel risk managers purchasing agents sales representatives general public manufacturing sites technical support commercial organization and Pharmacovigilance regarding AbbVie product complaints. Responsible for oversight of product complaint documentation investigations and identification of potential adverse events and potentially reportable events. They will also work closely with the PMQA leadership to help set the direction of the organization.
Responsibilities:
- Provide strategic direction and vision for team located around the world which is responsible for complaint processing. Has a future focused perspective to ensure we are staying ahead of trends.
- Influence the global teams to have an aligned and consistent approach with complaint intake handling.
- Oversee global and US complaint processing methods to ensure complaints related to medical devices combination products pharmaceutical and biologics products are appropriately handled and evaluated.
- Assure complaint records meet global requirements and ensure the team is staying up to date on current obligations.
- Author reply letters to customers addressing the results of complaint investigations. Assure complaint records meet global requirements.
- Identification of potentially reportable events and notification to appropriate functional groups. Lead efforts to resolve.
- Ability to create formal documentation that meets GMP standards and can be used for regulatory filings and/or reporting. Examples include: Form 3500A and Med Dev.
- Interface with Third Party Manufacturers health care professionals general public internal customers AbbVie functional areas and regulatory agencies.
- Oversight of management of a project team or participation on a project team involving process improvements new product launches issue resolutions etc.
- Support leadership in strategy development and continuous improvement activities.
Qualifications :
- Bachelors Degree required; preferably in nursing pharmacy medical technology engineering or scientific background (MLT LPN RN).
- 8 years of work experience in a cGMP related industry or in a clinical setting (preferred)
- 4 years of management experience preferred.
- Knowledge of global regulatory requirements for pharmaceutical medical devices and combination products.
- Knowledge of FDA Quality Systems pharmaceutical products and Medical Device Reporting regulations (21 CFR 803 820 and 211) is preferred.
- Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.
- Solid written/verbal communication and organizational skills.
- Knowledge and application of computer systems for word processing and complaint management.
- Ability to work with cross-functional teams and to interact effectively with peers management and customers.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Microsoft Access
- SQL
- Analysis Skills
- Microsoft Powerpoint
- Securities Law
- Data Mining
- Investment Banking
- Market Research
- Microsoft Excel
- Visual Basic
- Bloomberg
- Data Analysis Skills
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
