
Senior Quality Leadership Position
2 days ago
Job Opportunity:
The Senior Quality Leadership role is responsible for acting as the primary Quality Person on a manufacturing license.
This position provides scientific, quality, compliance, and patient-centered support to the manufacturing site. Key responsibilities include managing the quality team, supporting daily activities related to technical issues with products and suppliers, and adhering to all applicable GxP standards.
- Serving as the primary Quality Person at the manufacturing site for aseptically manufactured, parenteral products
- Offering advice, guidance, and support to quality professionals based on past experiences and knowledge
- Coaching and mentoring quality colleagues to develop problem-solving, decision-making, and critical-thinking skills
- Evaluating multiple data sources and perspectives to accurately characterize problems and opportunities; solving complex problems with little precedent
- Aligning views and reaching decisions by bringing together stakeholders with divergent views
- Contributing to Product Quality Technical Agreements within the Quality Department as needed
- Supporting inspection readiness, including developing playbooks and reviewing responses to GMP inspections
- Providing technical support for successful outcomes of all regulatory inspections
- Conducting vendor audits and site visits as required
- Overseeing the evaluation of quality and distribution complaints
- Leading projects and improvement efforts, including product launches
About this Role:
This senior leadership position plays a critical role in ensuring the highest quality standards are met across all aspects of the manufacturing process.
Responsibilities:
- Develop and implement quality strategies to improve processes and ensure compliance
- Lead cross-functional teams to resolve quality-related issues and drive continuous improvement
- Collaborate with stakeholders to develop and maintain quality policies and procedures
We Offer:
A competitive compensation package and opportunities for professional growth and development
Requirements:
A bachelor's degree in a relevant field and 10+ years of experience in quality leadership roles
What We're Looking For:
Candidates who possess excellent communication and leadership skills, with a strong background in quality management and compliance
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