J&J Family of Companies
Senior Manager Quality Control
J&J Family of Companies, Horsham, Pennsylvania, United States, 19044
J&J Family of Companies - Senior Manager Quality ControlLocation: Horsham, Pennsylvania
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.
This role will support the project phase across both design & construction and will require presence 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, requiring on-site presence in Wilson, NC. Based on your current location, the hiring team will work with you to determine travel and relocation arrangements, with expected 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. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today.
Essential Job Duties and Responsibilities:
Manage all aspects of the Quality Control (QC) laboratories in full compliance with established GMP and safety regulations.
Oversee and manage processes for:
Training 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.
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.
Review and/or approve quality documents and non-conformance investigations.
Support internal and external audits.
Analyze laboratory performance and quality data for quarterly site management and annual product reviews.
Utilize statistical tools and data analysis techniques to identify trends and drive continuous improvement initiatives.
Preparation of the annual Quality Control department budget and long-range financial plan.
Stay abreast of industry advancements and changes in regulatory guidelines.
Collaborate with cross-functional teams to support business needs.
Drive a culture of quality throughout the organization.
Qualifications
Required:
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 of global GMP regulatory requirements.
Experience interacting with health authorities and leading regulatory inspections.
Proficient in utilizing quality control and statistical tools for data analysis.
Excellent communication and interpersonal skills.
Strong leadership skills with the ability to inspire and motivate a team.
Strong analytical and problem-solving skills.
Detail-oriented mindset with a keen eye for identifying opportunities for process improvements.
An unquestionable level of integrity and commitment to operating ethically.
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).
This job posting is anticipated to close on 10/20/2024. The Company may 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.
#J-18808-Ljbffr
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.
This role will support the project phase across both design & construction and will require presence 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, requiring on-site presence in Wilson, NC. Based on your current location, the hiring team will work with you to determine travel and relocation arrangements, with expected 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. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today.
Essential Job Duties and Responsibilities:
Manage all aspects of the Quality Control (QC) laboratories in full compliance with established GMP and safety regulations.
Oversee and manage processes for:
Training 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.
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.
Review and/or approve quality documents and non-conformance investigations.
Support internal and external audits.
Analyze laboratory performance and quality data for quarterly site management and annual product reviews.
Utilize statistical tools and data analysis techniques to identify trends and drive continuous improvement initiatives.
Preparation of the annual Quality Control department budget and long-range financial plan.
Stay abreast of industry advancements and changes in regulatory guidelines.
Collaborate with cross-functional teams to support business needs.
Drive a culture of quality throughout the organization.
Qualifications
Required:
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 of global GMP regulatory requirements.
Experience interacting with health authorities and leading regulatory inspections.
Proficient in utilizing quality control and statistical tools for data analysis.
Excellent communication and interpersonal skills.
Strong leadership skills with the ability to inspire and motivate a team.
Strong analytical and problem-solving skills.
Detail-oriented mindset with a keen eye for identifying opportunities for process improvements.
An unquestionable level of integrity and commitment to operating ethically.
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).
This job posting is anticipated to close on 10/20/2024. The Company may 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.
#J-18808-Ljbffr