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Manager, QC Lab Services

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Job Description


Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a QC Lab Services Manager based in Titusville or Raritan, New Jersey. This role supports both the Raritan, NJ and Titusville, NJ Stability Lab locations, therefore routine travel between both sites is required.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Supply Group, LLC, is part of the Janssen Pharmaceutical Companies.

The QC Lab Services Manager is responsible for the Quality Control laboratory services support including Lab Documentation Management, Lab Systems and Applications support, Lab Equipment Lifecycle Management and Software Validation support, among others.

This position will also perform budget support as the point of contact for activities related to Capital Expense, Cost Improvement tracking/reporting and spend tracking and reporting. The QC Lab Services Manager is responsible for facilitating the performance management and laboratory planning processes through the laboratory scheduling/planning tools, reporting scorecard metrics and monitoring laboratory indicators.

The QC Lab Services Manager is accountable to manage and assure quality & compliance for all lab services and ensure all regulatory commitments are met.

This position is responsible for carrying out managerial responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training employees, appraising performance, rewarding and disciplining employees, addressing complaints and resolving conflict.

• Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Uphold our Credo values including creating a positive work environment
• Responsible for the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, certificate of analyses for new submissions, electronic laboratory system administration and Computer Software Validation/Software Development Lifecycle changes, laboratory equipment lifecycle management and CSV support coordination among others
• Maintain data integrity standards for all lab systems, applications, equipment, and instrumentation
• Responsible for supporting the performance management and laboratory planning processes through the laboratory scheduling/planning tools, reporting scorecard metrics and monitoring laboratory indicators
• Maintain close relationship with Enterprise Facilities Maintenance personnel
• Lead QC project activities to introduce new technologies and computer based applications to improve laboratory efficiency, reduce cycle time, reduce cost, and promote a culture of innovation.
• Support the equipment lifecycle management team for activities such as equipment purchase, qualification, CSV, troubleshooting, calibration and maintenance.
• Ensure appropriate collaborations with manufacturing sites and stability labs are maintained and stability protocols, studies, and samples are managed accordingly.
• Oversee the activities of the Sample Management Supervisor and team to ensure samples are appropriately placed into the stability program and managed over their lifecycle according to all local procedures and regulatory requirements
• Oversee stability chambers maintenance, qualification, and calibration including being able to provide 24/7 coverage to provide support in the event of a chamber excursion.
• Assess end to end laboratory performance processes, evaluate gaps, identify process improvements, and recommend solutions.
• Interact with Health Authority during inspections in a leading role, demonstrating expert knowledge in all Lab Service areas.
• This position will have ~6-8 direct reports and will be responsible to train, develop, coach and mentor employees from a technical and career development perspective.

Resource Management
• Train, develop, coach and mentor employees from a technical perspective as well as career development perspective
• Lead recruitment and make hiring decisions for open QC positions in the Lab Services space
• Manage performance of the laboratory staff and take disciplinary action, where required
• Establish performance objectives and development goals for employees
• Coordinate the schedules of resources to ensure efficient coverage for all operational needs, where required

Operational Excellence
• Actively participate in the planning and execution of strategies directed to achieve company goals and objectives
• Support network activities to create flexible resource strategies (e.g insource/outsource strategies)
• Support Process Excellence Projects and promote laboratory Yellow, Green, and Black belt certification among QC areas
• Lead projects, programs, committees, and special activities that the company promotes geared toward establishing its strategic goals
• Support in CIPs tracking and reporting and spend tracking and reporting
• Train / mentor employees on J&J project management methodologies (LEAN, J&J Operating System, Flawless Project Execution) to create Operational Excellence SMEs in the network

Capacity Planning and Performance Management
• Work with CPPM and Operational Excellence Lead for the Capex tracking, monitoring and reporting in Instantis
• Perform budget support as the point of contact for activities related to CAPEX, CIP tracking/reporting and spend tracking and reporting
• Ensures the maintenance of the laboratory planning/scheduling through Smart QC
• Assess end to end laboratory performance processes, evaluate gaps, identify processes improvements, and recommend solutions
• Point of contact to coordinate Business Plan data for network Business plan preparation

Equipment Lifecycle Management (ELM) & Lab Systems
• Lead QC project activities to introduce new technologies and computer base applications to improve laboratory efficiency, reduce cycle time, reduce cost, and promote culture of Innovation
• Supports the equipment lifecycle management team for activities such as equipment purchase, qualification, CSV, troubleshooting, calibration and maintenance
• Lead the support of laboratory documentation management system
• Lead the support of the One JSC Lab eLIMS Global Center of Excellence

Sample Management
• Well versed in global regulations and guidelines for marketed stability and developmental stability for a variety of dosage forms
• Ensure appropriate collaborations with manufacturing sites & stability labs are maintained and stability protocols, studies, and samples are managed accordingly
• Oversee the activities of the Sample Management Supervisor and Team to ensure samples are appropriately placed into the stability program and managed over their lifecycle according to all local procedures and regulatory requirements
• Oversee stability chambers maintenance, qualification, and calibration including being able to provide 24/7 coverage to provide support in the event of a chamber excursion

Projects / Meetings
• Lead functional and cross-functional team meetings as required
• Participate as a technical resource and departmental representative as it relates to all Lab Services on multi-functional, interdepartmental teams
• Support continuous improvement teams and ensure project execution is carried through to completion
• Connect with the QC Global organization being the point of contact for the different One JSC Lab centers of excellence for equipment and information technologies

Quality & Compliance
• Interact with Health Authority during inspections in a leading role, demonstrating expert knowledge in all Lab Service areas
• Ensure compliance to Janssen Quality global and local procedures, regulatory/HA requirements, and industry standards
• Maintain high level of familiarity with GMPs, CFR Part 11, and current regulatory guidelines related to instrument calibration and computer systems validation (e.g., GAMP 5, USP <1058>, 21 CFR Part 210/211 etc.).
• Maintain lab computer systems in a validated state following established GxP regulations.
• Develop and review laboratory technologies procedures and verify their compliance with internal and external requirements.


Qualifications
• A Bachelors degree required. Degree concentration in a scientific, engineering or related area is preferred. Advanced degree (MBA, MS or PhD) preferred.
• Minimum 8 years total experience working in a regulated quality environment with a minimum of 3 years experience directly leading people required.
• Knowledge and understanding of current regulatory requirements, GMPs, and standards related to laboratory equipment and systems (including USP <1058>, 21 CFR Part 11, and data integrity requirements) and ability to identify/remediate gaps required.
• Experience and/or certification in applying process improvement methodologies (lean, six sigma, design excellence, etc.) required.
• Technical knowledge and understanding of computer system validation (CVS) and application support required.
• Understanding of lab equipment and instrument qualification, preventative maintenance and calibration required.
• Detailed understanding of analytical methods and technologies utilized in stability laboratories and associated validation and transfer requirements preferred.
• Ability to interface with regulatory agencies required.
• Ability to establish and maintain cooperative working relationships with internal and external partners required.
• Experience in a Regulated Quality Environment preferred.
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols required.
• Ability to quickly process complex information and often make critical decisions with limited information required.
• Ability to manage multiple priorities daily while being flexible and responsive to frequently shifting priorities required.
• Ability to independently manage a portfolio of ongoing projects required.
• Advanced skills using Microsoft Office applications (Outlook, Excel, Word, Project and PowerPoint) required.
• Must have the ability to take initiative and work independently where appropriate, effectively manage timelines, organize files under regulatory scrutiny, and work independently.
• Must have strong leadership skills and operate as a leader with global mindset, understanding and appreciation of the global /enterprise context.
• Relationship management, excellent coaching and collaboration skills are required.
• Must be an analytical and strategic thinker with the ability to create integrated sector wide solutions to align with sector and enterprise requirements.
• Influence, shaping solutions, negotiation and consultative skills are required.
• Must be a thought leader experienced in shaping solutions, with strong communication and collaboration/partnership skills.
• Ability to communicate clearly and concisely, both orally and in writing to all levels required.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


IND10


Primary Location
United States-New Jersey-Titusville-
Other Locations
North America-United States-New Jersey-Raritan
Organization
JANSSEN SUPPLY GROUP, LLC (6046)
Job Function
Quality Control
Requisition ID
6874191007