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Job Description:

Johnson & Johnson Innovative Medicines (IM) is looking for a Manager, External Quality Small Molecules Drug Product.

Work Environment:

At Johnson & Johnson IM, we embrace a hybrid work model that effectively balances the advantages of in-office collaboration with the flexibility of remote work. For this role, you are expected to work on-site for a minimum of 3 days per week. This on-site presence is vital for fostering collaboration and engaging with cross-functional teams, ensuring that quality remains at the forefront of our operations. The remaining days of the week may be reserved for remote work, providing flexibility while allowing for team interaction.

This position can be based in J&J IM site locations Switzerland, Belgium, The Netherlands, Italy, or Ireland.

Our Commitment:

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Position Summary:

In this role, you will play an essential part in maintaining the highest quality and compliance standards for our small molecule products, specifically focusing on Drug Products, produced at external manufacturing sites. You’ll collaborate closely with our External Quality Site Leads and be a champion for quality in everything we do!

Key Responsibilities:

• Account ownership and account management for external manufacturer
• Maintain compliance with applicable company policies and procedures
• Assess current quality systems and recommend improvements to enhance quality and reduce cycle time.
• Monitor trends, identify issues, recommend, and implement appropriate actions.
• Provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.
• Coordinate and provide concurrences on deviations, change controls and CAPAs.
• Participate in audits of External Manufacturers.
• Assist with inspection readiness and regulatory inspections and provides follow up on regulatory commitments of external manufacturer.
• Investigate customer product quality complaints
• Apply cGMP regulations and other international requirements to all aspects of the position.
• Provide Quality oversight
• Interface with other functions (Operations, Planning, Technical Operations, etc) in the support of External Quality.
• Drive continuous improvement mindset and best practices at external manufacturer and within external quality
• Demonstrate site quality head mindset for the account
• Demonstrate ability to operate with minimal supervision and accountability to lead resolution of complex quality and compliance issues
• Lead and contribute to External Quality improvement projects

Minimum Qualification

• Minimally bachelor’s degree in science, Engineering and Technical subjects.
• Advance degree (MS, MBA) is preferred
• A minimum of 5 years of experience in Pharmaceutical or Medical device or Biotech or highly regulated environment is required
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• In depth knowledge of global cGMP requirements and ISO requirements is required
• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

Other requirements:

• Ability to travel up to 25% regionally
• Ensure training is complete timely
• Strong ability to manage problems and urgencies during issue management
• Ability to work virtually connecting with other sites, customers and global functions