- Provide quality oversight during the transfer of analytical methods.
- Oversee the development, verification, qualification, and validation of analytical methods by reviewing protocols, exceptions, and reports.
- Ensure adherence to FDA, USP, ICH, and internal regulatory policies for analytical method qualification and validation.
- Independently coordinate with internal departments and external CMOs / CTLs to facilitate project execution.
- Apply risk management principles to qualification and remediation efforts.
- Provide regular updates and reports to management on project status.
- Perform other related tasks as assigned.
Education and Skills Requirements :
- Bachelor's degree in a science-related field, with 8-12 years of relevant experience, preferably in biopharmaceutical or pharmaceutical industries.
- Direct experience with analytical method qualification and validation using FDA, USP, and ICH guidance.
- Hands-on experience with method development, qualification, and validation for clinical and commercial in-process and release testing.
- Strong understanding of GMP principles, concepts, and global validation standards.
- Knowledge of biologics / gene therapy processes is desirable.
- Ability to address complex quality issues with innovative and effective solutions.
- Familiarity with industry best practices and current trends in quality validation.
- Excellent verbal, written, and interpersonal communication skills.
Quality Lead / Senior Validation Engineer - 5039
Quality Lead Responsibilities:. Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5. Consults with QISM team members and relevant internal stakeholders to identify / ...
Quality Lead/ Lead Validation Engineer - 5122
Quality Lead Responsibilities:. Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5. Consults with QISM team members and relevant internal stakeholders to identify / ...
Salesforce Quality Engineer/ Test Lead - Global Salesforce
Slalom is seeking a Senior Salesforce Quality Engineer and test lead capable of delivering and leading testing activities on client projects and helping scale our Salesforce quality engineering practice. You will be expected to work directly with internal senior leaders to help build and expand our ...
Validation Lead (Labs) / Lead Validation Engineer/Analyst - 5150
Validation Lead (Laboratory) Analyst Responsibilities:. Independently lead the Client through the Validation Lifecycle required for their identified equipment. Capability to lead a Validation effort, from identification of applicable tests and requirements of an instrument to closure of all testing ...
Quality Lead/ Lead Validation Engineer - 5122
Quality Lead Responsibilities:. Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5. Consults with QISM team members and relevant internal stakeholders to identify / ...
Lead Engineer, Quality Validation
Familiarity with industry best practices and current trends in quality validation. Provide quality oversight during the transfer of analytical methods. Oversee the development, verification, qualification, and validation of analytical methods by reviewing protocols, exceptions, and reports. Ensure a...
Quality Lead / Senior Validation Engineer - 5039
Quality Lead Responsibilities:. Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5. Consults with QISM team members and relevant internal stakeholders to identify / ...
Validation / Lead Reliability Engineer
The Validation / Lead Reliability Engineer will lead and be an intrinsic part of a dynamic, collaborative team that believes deeply in the importance of what we are doing and that we can achieve it. Validation / Lead Reliability Engineer. The position requires significant cross-functional coordinati...
Validation Lead (Labs) / Lead Validation Engineer/Analyst - 5150
Validation Lead (Laboratory) Analyst Responsibilities:. Independently lead the Client through the Validation Lifecycle required for their identified equipment. Capability to lead a Validation effort, from identification of applicable tests and requirements of an instrument to closure of all testing ...
IT QA Lead, Policy
The IT QA Lead is accountable for engaging business users and IT team members throughout the lifecycle of projects and production. Owning all QA estimations as well as capacity versus demand planning in any given release, planning delivery in close conjunction with other Project IT Leads. Minimum of...