Manager Post Market Quality Assurance FM
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Under the responsibility of the Quality Director your role will be to act as one of the Site Quality representatives for commercialized AbbVie products and the global supply chain with a dedicated team under your supervision.
In this role you will have the following responsibilities:
Act as the primary quality representative for the global supply chain and make decisions regarding product quality in alignment with various stakeholders (both local and global)
Oversee and implement the global post-market surveillance strategy including the development and analysis of PSURs (Periodic Safety Update Reports) and the management of PMCF (Post Market Clinical Follow-up) in order to anticipate risks identify areas for improvement and guide organizational decisions
Oversee and implement the global complaint management strategy and review of market signals by strengthening a proactive approach to anticipate and evaluate customer satisfaction
Oversee and implement the supplier quality strategy to select evaluate and develop high-performing partners to meet our objectives of excellence innovation and compliance with standards Be responsible for the implementation and maintenance of the quality systems effectiveness by applying and maintaining quality policies procedures and systems within your scope
Guarantee the coordination of activities related to major quality events ensuring alignment engagement and involvement of global stakeholders in key decisions Manage stability programs integrate and leverage collected data and guide actions to ensure product reliability and durability Lead the implementation of trend reviews issue quality recommendations supporting the vision and mission of AbbVie Quality
Conduct audits monitor KPIs and deploy action plans
Establish and manage the budget for your department
Manage a multidisciplinary quality team. Engage and mobilize your team with a collaborative team-working performance and ownership mindset.
Qualifications :
You have the following strengths to join us:
- Advanced scientific degree (Masters degree or higher required) or pharmacist.
- Minimum of 10 years in quality assurance operations management regulatory affairs operations or technical support in a pharmaceutical environment.
- Knowledge of FDA ISO13485 requirements for medical devices or pharmaceuticals.
- Fluent in English (spoken and written).
- Organizational/management skills and the ability to manage a team
- Strong interpersonal skills for effective communication and teamwork
- Ability to synthesize information and present it
- Analytical and problem-solving skills positive interpersonal skills ability to manage multiple complex tasks simultaneously and act as a leader and team member.
- Solid knowledge in quality assurance/control manufacturing laboratory technical support regulatory affairs and/or validation is required.
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
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
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
