Johnson & Johnson Innovative Medicine · 9 hours ago
Quality Systems Manager
Wilson, NC
Full-time
Onsite
Senior Level
6+ years expJohnson & Johnson is a leader in healthcare innovation dedicated to improving health for humanity. The Quality Systems Manager will lead the Quality Systems team, ensuring the implementation and maintenance of robust quality management systems to support manufacturing processes while adhering to regulatory requirements.
Pharmaceuticals
Responsibilities
Responsible for developing, implementing, and monitoring effectiveness of all core Quality Systems in compliance with applicable regulations and industry standards (Nonconformance and CAPA, Change Control, Document Management, GMP training, quality agreements process, complaints system, and global J&J standard processes)
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
Provide guidance and support to departments on quality system-related matters
Manage the resolution of unexpected complex compliance or quality system issues as they arise
Develop and deliver training programs to enhance employees' understanding of quality systems and regulatory requirements
Keep abreast of regulatory changes and industry best practices related to quality systems and ensure timely implementation of necessary updates
Manage relationships with external regulatory agencies and auditors, supporting inspections and audits as required
Partner with peers and Quality Heads at other J&J sites to ensure harmonization and alignment with J&J Quality Policies, Guidelines, Programs and Systems
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 is required
A minimum of 6 years' experience working within the biological and/or pharmaceutical industry
Strong knowledge of relevant regulations and quality management principles, including Good Manufacturing Practices (GMP), ICH, and ISO standards
Deep understanding and experience applying global regulatory guidelines (e.g., FDA, EMA) in a biological or pharmaceutical manufacturing environment
Experience interacting with health authorities and leading regulatory inspections and audits
Unquestionable integrity and commitment to operating ethically and within regulatory boundaries
Excellent communication and interpersonal skills, with the ability to collaborate cross-functionally and communicate complex quality concepts to stakeholders at all levels
Strong analytical and problem-solving skills, with a proven track record in leading investigations and implementing effective CAPAs
Ability to manage multiple priorities independently with minimal supervision
Detail-oriented with a keen eye for identifying process improvement opportunities
Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment
Strong relationship-building skills with the ability to work effectively in team environments at all organizational levels
Results-driven leader with a commitment to achieving stretch goals and delivering results
Demonstrated success as a people leader
Preferred
Experience in people management within Quality
Experience in a supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D)
Certification in quality management systems (e.g., Certified Quality Manager, Certified Quality Auditor)
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
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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