Senior Manager External Quality

Company: Disability Solutions
Location: Raleigh
Posted on: April 12, 2025

Job Description:

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.comJob Function: QualityJob Sub Function: Quality AssuranceJob Category:ProfessionalAll Job Posting Locations:Raleigh, North Carolina, United StatesJob Description:Johnson and Johnson Supply Chain is recruiting for a Senior Manager External Quality! This position will be located in the Holly Springs, North Carolina.At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.Position Summary:The Sr. Manager, External Quality position will function as the on-site Johnson & Johnson Quality Lead for the FujiFilm Diosynth Biotechnologies site in Holly Springs, North Carolina (FDBN) and be responsible for the overall Quality and Compliance oversight of the FDBN site. The role is to establish a new way of working with the external partner (Condo model) to shape the working environment of the J&J on site QA and the interactions with the FDBN Quality functions. It will help facilitate the integration of the FDBN site in the J&J supply network.Provides leadership in the selection, development and management of additional on site or remote dedicated J&J Quality personnel.The position further contributes to the overall development, implementation, and execution of quality systems in support of external manufacturing, including the quality aspects of digital integration between FDBN and J&J.The position provides leadership to a team of Quality Assurance professionals.The position provides strategic direction from a Quality and Compliance point of view for this site and more specifically develops and/or adjust processes to take full advantage of the unique position of the site in the supply chain network.The position works closely with Partnership and External Supply (PES), Quality and Compliance functions,Internal J&J sites, Product Quality Management, Global Technical Operations and other stakeholders.Key Responsibilities:

• Together with FDBN QA management, build the quality system and achieve integration of these systems in both the FDBN as well as the J&J systems.
• Together with FDBN management prepares the site for GMP-ready state and, later on, for FDA approval state.
• Shape the release process of products produced to achieve agile release and integration in the J&J systems.
• Provide Quality Assurance, compliance and technical oversight to a portfolio of large molecule Drug substance products for the site.
• Drive a culture of continuous improvement and integration across the facility. Influence the strategic partner to further develop and integrate the quality function.
• Ensure that all relevant QA related concerns at the external manufacturing site are raised to J&J management.
• Ensure that the manufacturing operations for J&J at the external manufacturer site run smoothly from a QA point of view and in a compliant manner.
• Review batch documentation of products in scope prior to their release by the external manufacturer's quality unit.
• Provide leadership to a team of QA professionals to support the site in its operations.
• Drive further digital solutions in the Quality Arena.
• Ensure that personnel are recruited and trained to support activities in line with business needs and build and continue to develop a strong, solid, cohesive team within the FDBN site.
• Continue to develop a High Performing Credo based Culture with the partner and the various J&J functions on site.
• Provide strategic quality direction to colleagues in PES and Technical Operations, more specifically, in view of the business development projects at the site.
• As a member of the J&J External Quality (EQ) large molecule team, provide strategic leadership to the wider EQ team.
• Partner with PES, Tech Ops, and Planning in the framework of the Quartet in order to assure continued market supply in a lean and effective manner.
• Partner with key supporting functions including PQM, Compliance, regulatory, internal Site QA, to ensure all activities within external manufacturing are carried out in compliance with corporate, cGMP and other regulatory requirements.
• Provide Quality oversight and participate on technology transfer teams. Review and approve IQ,OQ, PQ and PPQ protocols and reports, where applicable.
• Provide guidance to execute the qualification program for the site in a timely fashion and meet the GMP ready date.
• Make sure the qualification audit is executed in a timely fashion.
• Provide quality and compliance oversight for new product introductions at the sDrive the development, writing and implementation of quality procedures required to produce at the FDBN site and for the interaction with the J&J supply chain.Support J&J Regulatory Compliance inspections at the EM.
  • Manage the interaction with the EM related to Follow-Up activities.
  • Provide guidance to the EM in the development of responses.
  • Verify, through follow-up activities, the EMs' completion of actions required to satisfactorily and effectively resolve observations related to audits, Significant Regulatory Actions and Significant Inspections
  • Escalate significant risks identified during the follow-up processQualifications:Education:A minimum of a Bachelors or equivalent University degree is required with a focus in pharmacy, pharmaceutical sciences, chemistry or biology preferred.Required:
    • Experience with a minimum of 8 years in a regulated environment is required; preferably in a pharmaceutical /Medical device/Biotech manufacturing or quality environment.
    • Advanced degrees are a plus and may reduce the experience required. Demonstrates knowledge of Quality Assurance, Quality Control and Compliance.
    • Experience in External Manufacturing, Technology Transfers, Quality Event Management and Quality System Development
    • Experience in management of a team
    • Ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues.
    • Experience in presenting issues to all levels of the organization.
    • Position requires to live near the FDBN site.
    • Demonstrates skills in the following Global Leadership areas: Integrity and Credo Based Actions, Sense of Urgency, Results and Performance Driven, Collaborate and Teaming and Prudent Risk Taking' cultural sensitivityPreferred:
      • Experience with management of complex projects
      • Experience with the building, qualification and start up of a facility
      • Experience in the development, implementation and review of SOPs for interactions with contract manufacturers.
      • Basic Principles of Aseptic Processing.
      • Experience investigating customer Product Quality Complaints.
      • Proficiency in computer applications such as the MS Office suite.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.

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