Quality Director

Job Description

We are currently seeking a Quality Director to join the Quality Team in Wilson, North Carolina.

This Quality Director is responsible for leading and managing all Quality related programs and activities to support manufacturing operations, including Quality Control testing, Quality Assurance review, compliance activities, product release, and more. The role also has the authority to make decisions regarding disposition of materials, quality and compliance matters, and reporting on the performance of the Quality System.

Initial focus (first 5 years) will be on leading and directing all quality aspects of the new U.S.

-based biotherapeutic manufacturing facility through conceptual design, basis of design, detailed design, construction, commissioning/qualification, process validation, and regulatory submission/approval.

Travel:
In steady state, less than 10% travel is expected, with project phase activity in the Greater Philadelphia region and operational support in Wilson, NC.

• Provide overall quality leadership and guidance to all site functional areas and management teams to ensure compliance with all regulations and high quality standards.
• Develop and champion a quality culture that promotes behaviors leading to superior business performance and organizational excellence.
• Partner with peers at other Innovative Medicine Supply Chain Sites to ensure harmonization and alignment with quality policies, guidelines, programs, and systems.
• Responsibly staff and develop the quality organization to meet business needs and succession plans, including mentoring, coaching, and training program implementation.
• Ensure financial leadership by developing appropriate operating and capital expense budgets.

• Minimum bachelor’s degree in science, pharmaceutical engineering, engineering, pharmacy, biochemistry, microbiology, biology, chemistry, or molecular biology. Advanced degree preferred.

• 10-15 years’ experience in a significant leadership position within the biological and/or pharmaceutical industry, with 5 years’ experience in a quality leadership role.
• Experience with FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals.
• Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
• Proven success in managing within a global organization.
• Strong knowledge in regulatory compliance, quality systems, pharmaceutical methods and procedures, and regulatory inspections.
• Quality management skills such as problem solving, statistical thinking, and design of experiments.
• Relationship skills: negotiation, presentation, listening, team management, and diversity facilitation.
• Excellent interpersonal, communication, and collaboration skills.
• Innovative, tenacious, and passionate about quality.
• Time management and attention to detail.
• Up-to-date with technical and managerial developments in the industry.
• Results- and performance-driven.
• Proven success as a people leader and ethical decision-maker.
• Adaptable, flexible, and empowered to make well-reasoned decisions.
• Commitment to operating ethically and within regulatory boundaries.
• Ability to work independently with minimal supervision.
• Support for a trusting, collaborative, and ethical work environment that enhances employee engagement.
• Commitment to the highest standards of ethics, quality, compliance, and accountability.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-) or contact AskGS to be directed to your accommodation resource.