Company Description
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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.
Job Description
We are currently hiring a Quality Systems Manager to join our team in Westport. The Quality Systems Manger is responsible for the processing of all electronic documentation and printing of controlled documents for Batch Records for the Westport site. The DCC and Quality Batch Issuance Department must maintain compliance with local, regulatory and legislative requirements with regards to Safety, Housekeeping, GMP and support and comply with internal environmental health and safety requirements, procedures and policies. It achieves these functions by interaction with QA, EHS, Compliance and regulatory affairs to ensure all internal procedures reflect current requirements.
Responsibilities:
- Management of the Document Control and Quality Batch Issuance Teams.
- Management of SOP, Manufacturing and QA Type Documents onsite.
- Hosting of Team Tier Board.
- Priority Scheduling.
- Collection of metrics for DCC and Quality Batch Issuance Departments.
- Processing of team GTW records.
- Oversight of addition of SOPs to LMS Compliance Wire.
- Approval of DCC related SOPs and internal documentation.
- Co-ordination of file retention activities onsite.
- Site Representation for Global Documentation Projects.
- Co-Ordination of Global Documentation updates for impact to local procedures.
- COE SME for Documentation at the Westport Site.
Qualifications
- 3+ years’ experience in a similar Quality Management role
- Proven leadership and team management experience in a Quality Team
- A relevant tertiary qualification is desirable
- Strong decision-making skills and the ability to work independently
- Excellent team-building skills
- Experience coordinating meetings with both Global and Local Teams
- Proficient in quality management systems
- Outstanding communication and interpersonal skills
- Excellent IT skills
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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
