Job Description
Descripción de la empresa
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Descripción del empleo
Support the global team responsible for processing complaints and inquiries from internal and external customers regarding medical devices and related complaints, such as those from sales agents, sales representatives, manufacturing sites, commercial teams, hospitals, or physicians. Additionally, provide leadership to the analyst team to ensure compliance with regulatory requirements throughout the process as well as effective team performance. Furthermore, the role includes ensuring compliance with corporate procedures, product quality, customer satisfaction, and maintaining the quality system while also overseeing the profitability of the process.
MAJOR RESPONSIBILITIES
- Provide daily direction to the local team of analysts responsible for processing complaints. Maintain a forward-looking perspective to anticipate trends.
- Manage the implementation of policies, procedures, and new product launches that impact the complaint processing department.
- Provide support as a complaint processing expert in internal and external audits.
- Ensure complaint records meet corresponding requirements and that the team stays up-to-date with current obligations.
- Lead internal controls to ensure required performance compliance for the team.
- Provide support as needed in other functional areas of PMQA, such as Intake or reporting.
- Act as executor of quality activities such as CAPAs (Corrective and Preventive Actions), internal audits, change controls, or procedures.
- Ensure the development of direct reports through tools provided by the organization.
- Prepare and present data related to product complaints.
- Ensure continuous improvement related to error control in data integrity through good documentation practices.
Requisitos
A university bachelor’s degree in technological, engineering, or scientific fields such as chemistry, pharmacy, biology, or microbiology.
- Advanced knowledge of English, at least B2 level according to the European framework.
- At least 3 years of work experience in a regulated medical device industry (GMPs) and quality, holding a technical or professional position.
- At least 1 year of experience supervising staff.
- Experience in project execution.
- Technical knowledge of regulations/standards: FDA 21 CFR part 803, 820, EU MDR, ISO 13485:2016 (preferred)
Información adicional
At AbbVie, we are committed to cultivating a workplace culture that promotes inclusion, diversity, and personal growth. We recognize that our collective success is based on the individual well-being of our employees, which is why we have designed a benefits package that considers every aspect of their lives.
- Enhanced Health and Wellness Coverage: Our administrative staff enjoys comprehensive medical and dental insurance, ensuring peace of mind for you and your loved ones.
- Extended Vacation: We believe in the balance between work and personal life for our administrative team. That’s why we offer additional vacation days, beyond legal requirements.
- Flexible Hybrid Work Model: For eligible positions within our administrative staff, we have adopted a hybrid work scheme allowing the convenience of working from home two days a week.
- Life Insurance: Secure your family’s future with our life insurance policy.
- Employee Assistance Program (EAP): Access professional support with our comprehensive EAP, offering psychological, legal, and financial counseling.
- On-Site Health Services: Benefit from the convenience of having a company doctor and physical therapy services, demonstrating our commitment to your health and well-being.
- Community and Social Engagement: Make a difference with a paid volunteer day, allowing you to contribute to the community during company working hours.
- Special Leave Benefits: Celebrate your life achievements with extra leave days for marriage and enjoy your birthday with a day off.
- Employee Stock Purchase Plan: Participate in our company’s success by purchasing shares at a special price exclusive to employees.
- Transportation and Meals subsidized.
- Solidary Association: Join a community focused on mutual help and enjoy the benefits that come with being a member.
AbbVie es un empleador que ofrece igualdad de oportunidades y se compromete a operar con integridad, impulsar la innovación, transformar vidas y servir a nuestra comunidad. Empleador que ofrece igualdad de oportunidades, veteranos y discapacitados.
