Manager Quality Operations delivering strategic leadership and subject matter expertise within the External Quality team at Johnson & Johnson. Leading team providing support for quality systems and regulatory assurance.
Responsibilities
Provides strategic leadership and subject matter expertise within the External Quality (EQ) team
Manages team providing support in execution of quality system and process troubleshooting
Serves as point of contact and Escalation Lead for coordination of Escalation activities
Optimizes existing transactional support models and evaluates potential expansion of services
Collects stakeholder feedback and develops business cases for additional centralization
Supports in budget activities and represents P&O in EQ Resource Modeling initiative
Coordinates with Account Owners and Platform Leaders to prioritize needs
Requirements
Bachelor’s degree (or equivalent) in a scientific or technical field
A minimum of 6 years working in an FDA regulated environment
A minimum of 3 years’ experience working with pharmaceutical GMPs
Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production
Strong interpersonal and written/oral communication skills
Proficient in applying process excellence tools and methodologies
Excellent analytical skill to identify gaps and root causes of issues.
Other languages than English are a benefit.
Excellent computer proficiency e.g. MS Office, SAP
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