Chief Commercial Officer leading commercial organization and global growth for premium sim racing technology. Expanding into new markets and drives revenue growth while advocating a human - centric culture.
About the role
- Maintaining quality oversight for Contract Manufacturing Organizations supporting GE HealthCare. Develop and sustain relationships with CMO partners to ensure compliance with quality and regulatory requirements.
Responsibilities
- Complete supplier qualification activities for prospective Contract Manufacturing Operations.
- Manage contracted colleagues hired to support outsourcing projects.
- Maintain quality oversight for a number of Contract Manufacturing Operations.
- Act as a single point of contact for all quality related activities at Contract Manufacturer.
- Manage all critical quality related issues (deviations, complaints, regulatory non-compliances etc)
- Assure Corrective and Preventive Action plans are developed and executed appropriately.
- Develop and maintain Quality Agreements between GE Healthcare and Contract Manufacturers.
- Responsible for the coordination and completion of audits, participating in and/or leading audits.
- Ensure Change Controls, initiated by supplier or by GE Healthcare are managed appropriately.
- Assist in Health Authority inspection preparations and providing support throughout as required.
- Track and trend key quality indicators / metrics to monitor supplier and QMS performance.
- Assure suppliers comply with all GE Healthcare QMS, procedures and regulatory requirements.
- Develop positive relationships with all internal partners, i.e. Sites, Sourcing, Supply Chain etc.
- Provide quality support for New Product Introductions and transfers project activities.
- Interact with Suppliers, Sites and Sourcing to drive improvements to minimize costs of quality.
- All other duties as assigned by manager.
Requirements
- Bachelors Degree in Science discipline (or non-technical degree with significant experience in manufacturing, engineering or equivalent knowledge or experience or quality assurance experience, or an Associate’s Degree with major manufacturing, engineering, or quality assurance experience)
- Effective problem-solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
- Proficiency with Microsoft Excel spreadsheet development and analysis.
- An ability to travel (up to 30%)
- Quality Site Head and/or eligibility to act as a Qualified Person
- Ability to effectively communicate within all levels of the organization
- Demonstrated collaboration, negotiation & conflict resolution skills.
- Excellent oral communication & report-writing skills in both.
- Ability to work within a matrix organization across different cultures
- Experience managing Contract Manufacturing operations (Active Pharmaceutical Ingredients, Finished Product), Contract Laboratories, GDP Service Providers
- Experience performing release activities for Pharmaceutical Products would also be desirable.
Benefits
- Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.
- Our salary and benefits are everything you’d expect from an organization with global strength and scale.
- You’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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