Senior Manager, Bio-Tox Analytical QA
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
We are currently hiring a Senior Manager Bio-Tox Analytical QA to join our team for a 23-month contract. The Senior Manager Bio-Tox Analytical QA is responsible for developing and overseeing a robust Quality Assurance strategy focused on the transfer of New Product Introduction (NPI) QC methods to manufacturing sites and Third-Party Laboratories. This role supports the Test Method Gate Review process reference standard and critical reagent controls and ensures the quality perspective is built into product development early. Covering mAbs ADCs Neurotoxins Gene Therapy and emerging biological entities across Immunology Oncology Neuroscience Eyecare and Aesthetics this position acts as a quality technical lead supporting strategic research compliance and collaboration across multidisciplinary teams.
Responsibilities:
- Review and approve Drug Substance and Drug Product specifications for Biologics Neurotoxins and Gene Therapy products.
- Support QA/QC business units by delivering program strategies managing projects and overseeing unit operations in line with business objectives.
- Provide quality technical leadership in multidisciplinary settings to keep activities on track with timelines and business needs.
- Support and execute development manufacturing and customer-centric plans.
- Develop negotiate and finalise project timelines and cost estimates to fulfil business and customer requirements.
- Apply advanced scientific expertise to manage and support complex multi-disciplinary projects.
- Use advanced technical writing skills to develop protocols and reports for product registration and business needs.
- Oversee processes and procedures to ensure product quality and regulatory compliance.
- Establish and enforce quality system procedures interfacing across development operations quality compliance and regulatory functions.
Qualifications :
- Bachelors degree in Chemistry Pharmacy Biology or a related scientific/technical field (required).
- Minimum 5 years experience in quality assurance operations regulatory or relevant area with at least 2 years in management.
- Familiarity with product/process requirements customer regulations (internal and external) and QA systems and GxP compliance for device biologics and pharmaceutical products.
- Strong influencing motivational and relationship-building skills across all staff levels.
- Effective at making operational/business decisions independently.
- Excellent written and oral communication skills and proficiency in English.
- Strategic thinker with enterprise-wide vision for compliance and business needs.
- Strong negotiation and collaboration skills with the ability to anticipate needs and manage matrix teams.
- Advanced computer skills particularly in enterprise systems such as SolTraqs Attache and Attache Pro.
This role can be performed from one of our sites in Ireland or near one of our sites.
The internal grade may vary depending on international location.
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
- Continuous Integration
- Quality Assurance
- FDA Regulations
- Root cause Analysis
- TFS
- Food Processing
- ICH Q10
- Jira
- Software Testing
- Quality Management
- Selenium
- Github
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
