Quality Systems Manager
About The Position
Responsible for all quality systems in scope from the Global Process Function/Operational process standpoint. Report to the Director of Quality Systems and Compliance. Responsible for initial implementation and validation support, periodic review and operational support to maintain systems in a validated state. Facilitate development, maintenance, and reporting of Quality System metrics to senior leadership on a periodic basis. Facilitate development and implementation of Global SOPs/Standards/Guidelines with respect to Quality Systems Management in-line with Alkermes Quality philosophy, regulations, and industry best practices. Evaluate and lead initiatives on harmonization of Quality Systems management. Facilitate and lead continuous improvement of approach to quality systems and processes by identifying, proposing and implementing systemic changes. Coordinate with other impacted Quality groups and Site Process Owners to gather input/feedback/requirements for quality system improvements. Ensure Quality Systems are validated and maintained in a validated state by developing, reviewing and approving appropriate validation documents in the Global System Owner role per validation procedures. In conjunction with Technical System Owners, Site Process Owners and relevant quality groups, responsible for coordinating and prioritizing requirements from various sites, both for initial implementation and ongoing changes in the operational phase.
Requirements
- Bachelor's degree in Pharmaceutical Science, Biomedical Engineering, or related field and seven years of GxP regulated experience.
- Experience must include seven years quality control/systems/assurance or research at commercial/clinical pharma/healthcare facility.
- Experience must include four years each of the following: US FDA, European regulatory requirements, and ICH Guidelines; GAMP; experience with cloud-based SaaS Quality Systems; and implementing and maintaining cloud-based Quality Systems.
Responsibilities
- Responsible for all quality systems in scope from the Global Process Function/Operational process standpoint.
- Report to the Director of Quality Systems and Compliance.
- Responsible for initial implementation and validation support, periodic review and operational support to maintain systems in a validated state.
- Facilitate development, maintenance, and reporting of Quality System metrics to senior leadership on a periodic basis.
- Facilitate development and implementation of Global SOPs/Standards/Guidelines with respect to Quality Systems Management in-line with Alkermes Quality philosophy, regulations, and industry best practices.
- Evaluate and lead initiatives on harmonization of Quality Systems management.
- Facilitate and lead continuous improvement of approach to quality systems and processes by identifying, proposing and implementing systemic changes.
- Coordinate with other impacted Quality groups and Site Process Owners to gather input/feedback/requirements for quality system improvements.
- Ensure Quality Systems are validated and maintained in a validated state by developing, reviewing and approving appropriate validation documents in the Global System Owner role per validation procedures.
- In conjunction with Technical System Owners, Site Process Owners and relevant quality groups, responsible for coordinating and prioritizing requirements from various sites, both for initial implementation and ongoing changes in the operational phase.
Benefits
- In addition, this position is eligible for an annual performance pay bonus.
- Alkermes offers a competitive benefits package.
- Additional details can be found on our careers website: www.alkermes.com/careers#working-here
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
1,001-5,000 employees
