Manager, QA Validation (Sterile Manufacturing)
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Job Location:
Danbury, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
MannKind is committed to developing and commercializing innovative therapeutic products for patients living with endocrine and orphan lung diseases. We are on a mission to give people control of their health and the freedom to live life.
At MannKind our employees are our number one asset and we foster a tight-knit community where each of us plays a critical role in our collective success. We strive to provide a work environment where diversity of background thought and perspective is valued and respected. Our team is also energized by the companys entrepreneurial spirit that provides an environment in which you can evolve ideas quickly and nimbly.
Our Values serve as the foundation of MannKinds culture. They define who we are how we act and guide our interactions every dayboth with each other and the customers we serve. At MannKind you will work with people who are experts in their fields see challenges as opportunities are tenacious and push boundaries bring creative and solutions-based thinking forward and always believe in winning together.
Position OverviewThe QA Validation Manager manages the validation activities supporting sterile drug product manufacturing and fillfinish operations. This role ensures that validation/qualification program/activities meet regulatory expectations and maintain a state of control across aseptic processing areas. The ideal candidate brings strong technical expertise in validation proven project and people management skills and deep understanding of sterile manufacturing and fillfinish processes. Adheres to quality and safety policies and procedures.
Key Responsibilities
Validation and People Management
- Develop risk-based qualification/validation strategy to support the activities
- Support generation review and approval of validation deliverables such as plans protocols and reports (supporting equipment facility utility computerized systems and processes)
- Supervise validation engineers/specialists (direct or contract) ensuring high technical competency and adherence to cGMP.
Aseptic & FillFinish Support
- Provide QA oversight for validation activities including process validation cleaning validation equipment qualification (IQ/OQ/PQ) utility qualification and computer system validation.
- Oversee validation activities related to aseptic processing sterilization (e.g. autoclaves dry heat ovens) and environmental monitoring systems.
- Evaluate and support qualification of cleanrooms HVAC systems compressed gases WFI and clean steam.
- Participate in aseptic process simulations (media fills) and ensure validation readiness.
- Support validation of formulation processes sterile filtration container closure systems and visual inspection technologies.
- Assess validation impact for changes to equipment components formulations or process parameters.
- Identify opportunities to optimize fillfinish validation strategies while maintaining compliance and product quality.
- Contribute to development and revision of SOPs templates and quality standards related to aseptic processing and fillfinish validation.
Quality Systems and Compliance
- Apply Quality Risk Management (ICH Q9) principles to validation strategies and decisions.
- Support investigations related to validation deviations equipment failures or sterility assurance risks
- Ensure validation activities align with FDA EMA ICH Annex 1 and industry best practices for sterile and fillfinish operations.
- Support regulatory inspections and internal audits serving as the subject matter expert for validation.
Required Qualifications/Skills
- Bachelors or masters degree in engineering Life Sciences or related field.
- 8 years of experience (6 years for masters degree) in validation/QA within a GMP sterile manufacturing or fillfinish environment.
- 3 years of experience in people management (direct or contract)
- Strong understanding of aseptic processing sterilization contamination control fillfinish and packaging operations.
- Working knowledge of validation lifecycle principles risk management and data integrity requirements.
- Familiarity with regulatory expectations including FDA EMA ICH Q7Q10 and EU Annex 1.
- Excellent communication documentation and cross functional collaboration skills.
Preferred Qualifications
- Experience with isolatorbased sterility testing and aseptic filling technologies.
- Experience supporting regulatory inspections (FDA EMA MHRA).
- Lean/Six Sigma or continuous improvement training.
Required Experience:
Manager
About Company
Drawing on the legacy of innovator and humanitarian Alfred E. Mann, our team of passionate scientists, researchers, and professionals develops cutting-edge therapeutic products and technologies that help people take control of their health and live—fully humann.
