Johnson & Johnson Innovative Medicine · 1 day ago
QC Lab Services Manager
Wilson, NC
Full-time
Onsite
Senior Level
6+ years expJohnson & Johnson is a leader in healthcare innovation, focusing on developing treatments and cures for complex diseases. The QC Lab Services Manager will lead the Quality Control laboratory services, manage lab documentation, and support compliance and quality systems within the organization.
Pharmaceuticals
Responsibilities
Responsible for the Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management and CSV support coordination, among others
Perform budget support as the point of contact for activities related to CAPEX, CIP tracking /reporting and spend tracking and reporting
Support and facilitate the performance management and laboratory planning processes through the laboratory scheduling/planning tools, reporting scorecard metrics and monitoring laboratory indicators
Lead QC project activities to introduce new products, technologies and computer base applications to improve laboratory efficiency and promote culture of Innovation
Connect with the QC Global organization being the point of contact for the different center of excellence for equipment and information technologies
Manage the development of a long-term vision and strategy for these quality systems in close cooperation with the site leadership and translating these strategies into compliant programs and processes in line with regulations and business expectations
Responsible for the site’s Management Review program including the Quality metrics program, to ensure and proactively enhance compliance and business performance of the site
Responsible for hiring, managing, leading, and motivating the Quality Systems team; inclusive of mentoring, training, and development of department employees
Manage the resolution of unexpected complex compliance or quality system issues as they arise
Keep abreast of regulatory changes and industry best practices related to laboratory services and ensure timely implementation of necessary updates
Manage relationships with external regulatory agencies and auditors, supporting inspections and audits, as required
Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset
Support the development of the Quality department budget in line with routine business planning cycles
Qualification
Required
Bachelor's degree in a scientific or engineering discipline
Minimum of 6 years of experience working within the biological and/or pharmaceutical industry
Experience in a Quality leadership role
Analytical equipment qualification experience
Experience working with Quality Control laboratory services support including Lab documentation management, material/supplies purchase, eLims support, laboratory equipment lifecycle management, systems and/or CSV support coordination
Deep understanding and experience in application of global regulatory (FDA, EMA, ICH, etc.) guidelines in a biological or pharmaceutical manufacturing environment
Experience interacting with health authorities and taking a leading role in regulatory inspections and audits
Preferred
Experience in supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.)
Certification in quality management systems (e.g., Certified Quality Manager, Certified Quality Auditor)
An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels
Strong analytical and problem-solving skills, with a track record in leading investigations and implementing effective CAPAs
Proven ability to manage multiple priorities and work independently with minimal supervision
Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements
Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment
Ability to build and nurture strong and positive relationships
The ability to work in a team environment and interact with all levels of the organization
Results-driven leader who commits to stretch goals and delivers results
Company
Johnson & Johnson Innovative Medicine
Johnson and Johnson Innovative Medicine focuses on developing medical solutions for some of the challenging diseases and medical conditions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Molly Perkins
VP, Head of Cell & Genetic Medicines Discovery
Recent News
2025-08-14
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