Associate Director, Quality Assurance
About the role
This is a Fully Remote Job
About Our Client:
The organization operates within the biotechnology and pharmaceutical industry, focusing on maintaining and advancing quality assurance and control processes. It addresses the challenges of ensuring compliant, efficient, and scalable quality operations across global teams by leveraging enterprise digital technologies and integrated platforms.
Responsibilities
- Develop and define the multi-year roadmap for quality digital capabilities.
- Prioritize and deliver quality capability improvements through governance.
- Provide business ownership for QA/QC digital systems in partnership with IT.
- Translate complex quality requirements into functional and system requirements.
- Standardize and simplify quality processes enabled by enterprise systems.
- Evaluate and lead adoption of new IT system features relevant to quality.
- Support quality data governance for consistent metrics and reporting.
- Manage release planning and change control for QA/QC systems.
- Ensure inspection-ready documentation for quality-owned capabilities.
- Guide quality users on compliant system and data use.
- Lead reviews of system performance and compliance posture.
- Contribute to validation strategy using quality risk management principles.
- Maintain functional knowledge of relevant quality management systems.
- Cook up with owners of related systems to promote process consistency.
- Facilitate governance forums for quality capability requests.
Requirements
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
- 8+ years in quality or related roles within biotechnology or pharmaceutical industries.
- 5+ years experience with SAP in a quality context, including Quality Management modules.
- 7+ years experience with Veeva Vault Quality or similar QMS technology.
- Knowledge of complementary systems such as ERP, LIMS, MES.
- Strong understanding of GxP quality data domains and use of metrics.
- Experience with Quality Risk Management (ICH Q9).
Pay, Benefits & Schedule
The pay range and compensation package for this role will be determined based on the candidate's experience, skills, and other relevant factors.
Equal Opportunity Statement
Our client is an equal opportunity employer. They celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, or national origin.