Senior Manager, Quality Control

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:

People Leader

All Job Posting Locations:

Titusville, New Jersey, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Senior Manager, Quality Control, Stability Operations. This position will be located in Titusville, NJ.

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:

The Senior Manager of QC Stability Operations oversees the daily functions of the Small Molecule Pharmaceutical Quality Control stability laboratory.  Key responsibilities include planning, executing testing, analyzing and trending data, reporting findings, managing quality events and ensuring adherence to laboratory and equipment qualification and maintenance. This role also contributes to long-term planning, budgeting, forecasting, objective setting, and strategic business growth within Stability Operations.

The Senior Manager is accountable for maintaining quality and compliance across all laboratory activities, ensuring adherence to regulatory requirements.

Additionally, this position entails managerial responsibilities in alignment with the organization’s policies and applicable laws. Duties encompass interviewing, hiring, training employees, evaluating performance, rewarding and disciplining staff, and addressing complaints and conflicts.

Key Responsibilities:

General

• Ensure a safe work environment that complies with all relevant environmental, health, and safety regulations.
• Uphold Credo values by fostering a positive workplace culture.
• Oversee the development plans for all team members.
• Ensure the Stability Laboratory operates efficiently and effectively.
• Manage long-term planning, budgeting, and forecasting activities.
• Establish and implement SMART objectives for the team.
• Assess team performance in relation to established goals and objectives.
• Support the organization’s inspection readiness initiatives.
• Ensure compliance with regulatory and internal commitments.
• Execute managerial duties in alignment with organizational policies and applicable laws.
• Optimize the management of team resources.
• Stay informed on regulatory guidance and industry standards pertaining to the stability program.

Laboratory Management (60%)

• Oversee stability laboratory operations, including program management, testing, data analysis, and report writing.
• Ensure lean and robust processes comply with applicable cGMPs and IM Supply Chain Global Standards.
• Manage method transfers and oversee commercial, annual, and development stability programs, including testing, trending, reporting, and ensuring appropriate staffing and training.
• Lead quality investigations for OOT/OOS, CAPAs, and quality system metrics within Stability Operations, handling escalations as necessary.
• Serve as a liaison to internal and external partners, facilitating health authority and DEA inspections.
• Conduct budget planning and monitor the organization’s financial status.
• Stay updated on regulatory guidance and industry standards related to stability testing, ensuring laboratory readiness for inspection.
• Report on the status of established quality metrics.
• Ensure facilities and equipment are maintained in optimal condition.
• Maintain necessary site registrations, including FDA and DEA as applicable.

Resource Management (30%)

• Train, develop, coach, and mentor employees in tech