At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

Athens, Georgia, United States of America, Beerse, Antwerp, Belgium, Dublin, Ireland, Geel, Antwerp, Belgium, Gurabo, Puerto Rico, United States of America, Horsham, Pennsylvania, United States of America, Huejotzingo, Puebla, Mexico, Latina, Italy, São José dos Campos, São Paulo, Brazil, Titusville, New Jersey, United States of America

Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

The Sr. Manager Lab Operations has responsibility for execution of the lab strategy across the Small Molecules (SM) platform sites. This position will work directly with platform quality leadership, site quality leadership and Innovative Medicine (IM) Q&C Lab Operations to ensure effective delivery of laboratory solutions to SM platform sites. The position will interface across expert functions to ensure reliable and compliant lab processes. Additionally, the position will support lab planning, lead lab CoP and support lab network strategy.

Key Responsibilities:

• Lead SM Lab leads CoP and support lab execution through benchmarking and best practices implementation.
• Support implementation of SM platform network strategy and sourcing decisions.
• Support each Lab in addressing its site and network demands.
• Support testing and operating strategies to maximize the efficiency and effectiveness of the QC operations.
• Develop and deploy cost competitiveness focus and ensure the culture of continuous improvement is strong within the Small Molecule QC network.
• Lead platform implementation of data integrity requirements and serve as SM Quality platform SME.
• Lead overall Quality performance management process execution for the SM Q platform Tier 4 and Lab QPMR.
• Ensure successful and fit for purpose deployment and adoption of digital tools and new technologies within the SM laboratories.
• Partner effectively with DPDS and MSAT to embed quality control in our supply chain processes, such as PAT and data monitoring.
• Work with peers and the other Quality control leaders globally to deploy and embed standardized processes through the laboratories

Other Duties

Other activities as the need arises, for example: participate in strategic projects, process enhancement initiatives, HA inspection support, etc.

Required Minimum Education:

Bachelor’s degree (BS/BA). A focused degree in Life Sciences, Pharmacy, Engineering is desirable.

Required Years of Related Experience:

• Minimum of 12 years of experience, 5 plus years’ experience and proven leadership in a quality control function within a Pharmaceutical, Medical Device and/or OTC Drug Industry environment.
• Strong Quality and Compliance background with a deep understanding of Global cGMP requirements and the systems used to deploy them.
• Strong background in site-based quality with inspection experience.

Required Knowledge, Skills and Abilities:

• Strong background in laboratory operations.
• Subject matter expertise in data integrity.
• Proven experience in operational excellence, process improvement and performance management within laboratories or manufacturing.
• Knowledge of digital transformation, automation and relevant technologies.
• Experience in working in a global environment
• Strong influencing and negotiation skills.
• Excellent written and oral communication skills.
• Strong interpersonal skills, including ability to communicate with individuals and groups at all levels.
• Experience in establishing strong collaborations with other functions within the company.
• Strong decision making and analysis skills.
• Demonstrated conflict and change management skills.
• Sense of Urgency - ability to lead and deliver on multiple projects in a timely manner.
• Systems Thinker – understanding how process / actions interact and influence other areas within a whole.

Percentage Traveled:

Approximately 10-20% global travel

 

 

Required Skills:

 

 

Preferred Skills:

Compliance Management, Corrective and Preventive Action (CAPA), Human-Computer Relationships, Industry Analysis, Organizing, Performance Measurement, Product Testing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Researching, Standard Operating Procedure (SOP), Strategic Thinking, Technical Credibility