Johnson & Johnson is currently seeking a Quality Control Lab Services 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%.
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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&J's 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 world's 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.
We are currently seeking a highly qualified individual to join our team as a QC Lab Services Manager at our new Large Molecule Drug Substance Manufacturing facility. In this key role, you will be responsible for leading the 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.
Essential Job Duties and 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.
Qualifications
Required:
- Bachelor's degree in a scientific or engineering discipline.
- Minimum of 6 experience working within the biological and/or pharmaceutical industry.
- Experience in a Quality leadership role.
- 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 a 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.
Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.
If you are passionate about quality management in the pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a Quality Systems Manager. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment.
This job posting is anticipated to close on 12/31/2024. 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.
The anticipated base pay range for this position is $100,000 to $172,500. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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 Company's 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
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.