J&J Family of Companies
Senior Manager Quality Control
J&J Family of Companies, Rocky Mount, North Carolina, us, 27815
J&J Family of Companies Senior Manager Quality Control Rocky Mount, North Carolina Apply Now
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.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 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 areas including 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 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!In 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.Essential Job Duties and Responsibilities: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:Training (skills-based, GMP and safety) of supervisors and associates within the department.Raw material, in-process, environmental/utility, microbiological and biotherapeutic drug substance release testing.Investigation of laboratory non-conformances and development of effective CAPAs for identified root causes.Maintenance, calibration and qualification of laboratory instruments and equipment.Qualification and administration of electronic laboratory systems.Test method verification, qualification, co-validation and/or transfer activities in the QC laboratories.Troubleshooting complex laboratory issues.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.Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset.QualificationsRequired:A minimum of Bachelor's degree in Chemistry, Biochemistry, or a related field.A minimum of 8 years’ experience working within the biological and/or pharmaceutical industry.A minimum of 5 years’ experience working in QC supervisory/management roles.Deep understanding and experience in application of global GMP regulatory requirements (FDA, EMA, etc.) and industry guidelines in a biological or pharmaceutical manufacturing environment.Experience interacting with health authorities and taking a leading role in regulatory inspections and audits.Proficient in utilizing quality control and statistical tools for data analysis and process improvement.Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.Strong leadership skills with the ability to inspire and motivate a team of professionals.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.Preferred:Master's degree in Chemistry, Biochemistry, or a related field.Experience in a supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.)This job posting is anticipated to close on 10/20/2024. The Company may however extend this time-period.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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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.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 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 areas including 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 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!In 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.Essential Job Duties and Responsibilities: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:Training (skills-based, GMP and safety) of supervisors and associates within the department.Raw material, in-process, environmental/utility, microbiological and biotherapeutic drug substance release testing.Investigation of laboratory non-conformances and development of effective CAPAs for identified root causes.Maintenance, calibration and qualification of laboratory instruments and equipment.Qualification and administration of electronic laboratory systems.Test method verification, qualification, co-validation and/or transfer activities in the QC laboratories.Troubleshooting complex laboratory issues.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.Drive a culture of quality throughout the organization, promoting a proactive approach to quality management and fostering a continuous improvement mindset.QualificationsRequired:A minimum of Bachelor's degree in Chemistry, Biochemistry, or a related field.A minimum of 8 years’ experience working within the biological and/or pharmaceutical industry.A minimum of 5 years’ experience working in QC supervisory/management roles.Deep understanding and experience in application of global GMP regulatory requirements (FDA, EMA, etc.) and industry guidelines in a biological or pharmaceutical manufacturing environment.Experience interacting with health authorities and taking a leading role in regulatory inspections and audits.Proficient in utilizing quality control and statistical tools for data analysis and process improvement.Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.Strong leadership skills with the ability to inspire and motivate a team of professionals.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.Preferred:Master's degree in Chemistry, Biochemistry, or a related field.Experience in a supporting functional area (e.g., Manufacturing, Technical Operations, Engineering & Maintenance, R&D, etc.)This job posting is anticipated to close on 10/20/2024. The Company may however extend this time-period.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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