Senior Manager Quality Control

Company: Disability Solutions
Location: Wilson
Posted on: October 19, 2024

Job Description:

Johnson & Johnson is currently seeking a Senior Manager Quality Control to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.\rWhile 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%.\rJ&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.\rAt 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/.\rFor 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.\rWe 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.\rAt Johnson & Johnson, we all belong.\rAre you a seasoned professional with a passion for quality control in the biopharmaceutical industry? Do you thrive on ensuring strict compliance with regulatory standards and driving continuous improvement in laboratory operations? If so, we have an exciting opportunity for you to join our team as the Quality Control Senior Manager at our new Large Molecule Drug Substance Manufacturing facility!\rIn this position, you will play a crucial role in ensuring the safety, efficacy, and compliance of our products through effective management and oversight of our QC laboratories while leading a team of skilled people leaders and technical professionals, driving their professional growth, and creating a culture of excellence. Your leadership will be instrumental in delivering and maintaining our laboratory's compliance, right-first-time execution, and operational efficiency.\rEssential Job Duties and Responsibilities:\r

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• Manage all aspects of the Quality Control (QC) laboratories in full compliance with established GMP and safety regulations as well as all company/site policies and procedures.
• Responsible for overseeing and managing processes for;\ro Training (skills-based, GMP and safety) of supervisors and associates within the department.o Raw material, in-process, environmental/utility, microbiological and biotherapeutic drug substance release testing.o Investigation of laboratory non-conformances and development of effective CAPAs for identified root causes.o Maintenance, calibration and qualification of laboratory instruments and equipment.o Qualification and administration of electronic laboratory systems.o Test method verification, qualification, co-validation and/or transfer activities in the QC laboratories.o Troubleshooting complex laboratory issues.
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  • Responsible for hiring, managing, leading, and motivating the QC department personnel; including mentoring, training, and career development.
  • Review and/or approve quality documents (standard operating procedures, specifications, test methods, work instructions, risk assessments, technical/validation protocols and reports, etc.), non-conformance investigations, CAPA, and change controls associated with the QC laboratories.
  • Support internal and external audits, including external contract laboratories and GMP service providers, where required.
  • Analyze laboratory performance and quality data for quarterly site management and annual product reviews.
  • Utilize statistical tools and data analysis techniques to identify trends, monitor quality metrics, and drive continuous improvement initiatives.
  • Preparation of the annual Quality Control department budget and long-range financial plan for laboratory capital investments.
  • Stay abreast of industry advancements and changes in regulatory guidelines and requirements, and proactively implement necessary updates to the laboratory's quality control practices.
  • Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering, Maintenance, Value Chain/Product Quality Management and Regulatory Affairs to support business needs.
  • Partner with QC Leaders at other J&J sites to contribute to global strategies and to ensure harmonization and alignment with J&J Quality Policies, Procedures, Programs and Systems.
  • Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset.\r\r

Keywords: Disability Solutions, Raleigh , Senior Manager Quality Control, Accounting, Auditing , Wilson, North Carolina