Quality Systems Manager

Quality Systems Manager – 2406205420W

Description

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

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.

J&J is expanding our manufacturing capacity with $2 billion investment to support strong portfolio growth and continue delivering breakthrough innovation and transformational medicines for 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.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the worlds most pressing healthcare challenges.

We know that the success of our business and our ability to deliver meaningful solutions depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

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).

This job posting is anticipated to close on 10/20/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

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: – https://www.careers.jnj.com/employee-benefits

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

Primary Location NA-US-North Carolina-Wilson

Other Locations NA-US-North Carolina-Raleigh, NA-US-North Carolina-Goldsboro, NA-US-Pennsylvania-Horsham, NA-US-Pennsylvania-Philadelphia, NA-US-North Carolina-Greenville, NA-US-North Carolina-Rocky Mount

Organization Janssen Biotech, Inc. (6014)

Job Function Quality Assurance

Req ID: 2406205420W