Global Commercial Quality Systems Manager
Global Commercial Quality Systems Manager
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Job Description
The Global Commercial Quality Systems Manager is a pivotal role responsible for ensuring quality assurance guidance and support for pharmaceutical products medical devices combination products and biologics. This position oversees the governance of affiliate quality systems providing operational support to ensure compliance and business objectives are met. As a key member of the Quality System Centre of Excellence (CoE) this role leads continuous improvement projects and serves as a global representative for affiliates.
This person can be based in any country where we have an affiliate office.
Responsibilities:
- Develop and implement strategies for quality regulations affecting drug biologics device and combination products across affiliates.
- Act as a critical interface between Operations Quality Systems and Affiliate QA ensuring alignment with local market regulatory requirements and ICHQ9 standards.
- Support affiliate QA teams with standard policies and processes ensuring consistent global execution.
- Evaluate and analyse quality indicators and data proposing improvement opportunities.
- Drive the global Audit Comfortable program in preparation for audits and inspections and support CAPA plans.
- Review compliance assessments to identify and address gaps and implement improvements in affiliate quality systems.
- Lead global project teams focusing on agility and improvement opportunities.
- Provide technical support documentation and training for GxP Quality Systems to affiliates.
- Collaborate with internal and external partners to develop best practices for quality systems.
Qualifications :
- Bachelors Degree in Chemistry Pharmacy Biology Microbiology Engineering or a related technical/scientific field preferred.
- Minimum of 7 years of experience in quality assurance operations or regulatory environments.
- Technical knowledge in Quality Regulatory Process Sciences and Manufacturing Operations.
- Experience in QA auditing and continuous improvement methodologies.
- Strong project management skills and analytical capabilities for complex scenarios.
- Ability to make decisions with minimal direction and lead global project teams.
- Strong communication interpersonal negotiation and influencing skills.
- Proficiency in English and knowledge of QA systems and GMP compliance regulations for devices biologics and pharmaceuticals.
Grades will vary depending on country.
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
Employment Type
Full-time
