Quality Systems Manager

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at & Johnson is currently seeking a Quality Systems Manager to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson North Carolina.

This role will support the construction operational start-up and end state of the DS site operations located in Wilson NC. For this you will be required to be 5 days a week on the site in Wilson NC. Based on the current project stage the travel requirements will be less than 10%.

J&J is expanding our manufacturing capacity with $2 billion investment to support strongportfolio growth and continue delivering breakthrough innovation and transformational medicinesfor patients. The new facility will expand production of innovative biologic medicines in areas including oncology immunology and neuroscience. J&Js significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

In this key role you will be responsible for leading the Quality Systems team and for ensuring the implementation and maintenance of robust quality management systems to support the manufacturing processes while ensuring adherence to regulatory requirements.

Essential Job Duties and 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 sites 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.

Qualifications

Required:

• Bachelors 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).

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance.

Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• 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

Additional information can be found through the link below.

For additional general information on Company benefits please go to: - & 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 and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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