J&J Family of Companies
Senior Manager Quality Control
J&J Family of Companies, Raleigh, North Carolina, United States, 27601
J&J Family of Companies Senior Manager Quality Control - Raleigh, North Carolina
Senior Manager Quality Control - 2406205418WDescriptionJohnson & Johnson is currently seeking a Senior Manager Quality Control to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.This role will support the site operations in Wilson, NC, and the project phase across both design & construction. You will be required to be present with our design teams in the Greater Philadelphia region during the design phase. Once completed, this role will support the construction and operational start-up of the site, with travel expected to be less than 10%.J&J is expanding our manufacturing capacity with a $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 oncology, immunology, and neuroscience.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.Are you a seasoned professional with a passion for quality control in the biopharmaceutical industry? Do you thrive on ensuring 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!Essential Job Duties and Responsibilities:Manage all aspects of the Quality Control (QC) laboratories in compliance with GMP and safety regulations.Oversee training of supervisors and associates within the department.Manage raw material, in-process, environmental/utility, microbiological and biotherapeutic drug substance release testing.Investigate laboratory non-conformances and develop effective CAPAs.Maintain, calibrate and qualify laboratory instruments and equipment.Qualify and administer electronic laboratory systems.Conduct test method verification, qualification, co-validation and/or transfer activities.Troubleshoot complex laboratory issues.Review and approve quality documents related to QC laboratories.Support internal and external audits.Analyze laboratory performance and quality data for management reviews.Utilize statistical tools for data analysis and process improvement.Prepare the annual Quality Control department budget.Stay updated on industry advancements and regulatory guidelines.Collaborate with cross-functional teams to support business needs.Drive a culture of quality throughout the organization.QualificationsRequired:Bachelor's degree in Chemistry, Biochemistry, or a related field.8 years’ experience in the biological and/or pharmaceutical industry.5 years’ experience in QC supervisory/management roles.Deep understanding of global GMP regulatory requirements.Experience with health authorities and regulatory inspections.Proficient in quality control and statistical tools.Excellent communication and interpersonal skills.Strong leadership skills.Strong analytical and problem-solving skills.Detail-oriented with a focus on process improvements.Ability to manage multiple priorities independently.Preferred:Master's degree in Chemistry, Biochemistry, or a related field.Experience in a supporting functional area (Manufacturing, Technical Operations, etc.).This job posting is anticipated to close on 10/20/2024. The Company may extend this time-period, in which case the posting will remain available on
https://www.careers.jnj.com .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.
#J-18808-Ljbffr
Senior Manager Quality Control - 2406205418WDescriptionJohnson & Johnson is currently seeking a Senior Manager Quality Control to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.This role will support the site operations in Wilson, NC, and the project phase across both design & construction. You will be required to be present with our design teams in the Greater Philadelphia region during the design phase. Once completed, this role will support the construction and operational start-up of the site, with travel expected to be less than 10%.J&J is expanding our manufacturing capacity with a $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 oncology, immunology, and neuroscience.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.Are you a seasoned professional with a passion for quality control in the biopharmaceutical industry? Do you thrive on ensuring 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!Essential Job Duties and Responsibilities:Manage all aspects of the Quality Control (QC) laboratories in compliance with GMP and safety regulations.Oversee training of supervisors and associates within the department.Manage raw material, in-process, environmental/utility, microbiological and biotherapeutic drug substance release testing.Investigate laboratory non-conformances and develop effective CAPAs.Maintain, calibrate and qualify laboratory instruments and equipment.Qualify and administer electronic laboratory systems.Conduct test method verification, qualification, co-validation and/or transfer activities.Troubleshoot complex laboratory issues.Review and approve quality documents related to QC laboratories.Support internal and external audits.Analyze laboratory performance and quality data for management reviews.Utilize statistical tools for data analysis and process improvement.Prepare the annual Quality Control department budget.Stay updated on industry advancements and regulatory guidelines.Collaborate with cross-functional teams to support business needs.Drive a culture of quality throughout the organization.QualificationsRequired:Bachelor's degree in Chemistry, Biochemistry, or a related field.8 years’ experience in the biological and/or pharmaceutical industry.5 years’ experience in QC supervisory/management roles.Deep understanding of global GMP regulatory requirements.Experience with health authorities and regulatory inspections.Proficient in quality control and statistical tools.Excellent communication and interpersonal skills.Strong leadership skills.Strong analytical and problem-solving skills.Detail-oriented with a focus on process improvements.Ability to manage multiple priorities independently.Preferred:Master's degree in Chemistry, Biochemistry, or a related field.Experience in a supporting functional area (Manufacturing, Technical Operations, etc.).This job posting is anticipated to close on 10/20/2024. The Company may extend this time-period, in which case the posting will remain available on
https://www.careers.jnj.com .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.
#J-18808-Ljbffr