Johnson & Johnson Innovative Medicine
Manager External Clinical Supply Quality
Johnson & Johnson Innovative Medicine, Titusville, New Jersey, us, 08560
Manager External Clinical Supply Quality
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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.com .
Job Function Quality
Job Sub Function Quality Assurance
Job Category Professional
All Job Posting Locations Bridgewater, New Jersey; Horsham, Pennsylvania; Malvern, Pennsylvania; New Brunswick, New Jersey; Raritan, New Jersey; Spring House, Pennsylvania; Titusville, New Jersey.
Job Description Johnson & Johnson is currently recruiting for a
Manager External Clinical Supply Quality
position. This role can be located in New Jersey, Pennsylvania, or Beerse, Belgium.
Position Summary The Manager, External Clinical Supply Quality role is responsible for the quality and compliance in the selection, qualification, monitoring, and management of external suppliers used for the packaging, labeling, over-encapsulation, and distribution of investigational medicinal products. The individual will also support coaching and development within the team and pursue continuous improvement for proactive quality and business needs.
Key Responsibilities
Serve as a quality contact point for the External Manufacturer/Supplier regarding J&J product at the external facility and hold signatory authority for QA on those projects.
Support or lead qualification during selection and routine monitoring of suppliers, including leading clinical audits and negotiating quality agreements.
Contribute to the overall development, implementation, and execution of quality systems supporting external suppliers.
Provide cGMP compliance support by proactively managing quality using risk‑based approaches and investigating quality issues and product quality complaints.
Drive phase‑appropriate GMP implementation at external packaging and label suppliers to meet business requirements.
Build relationships and collaborate with suppliers and internal stakeholders to drive compliance and continuous improvement initiatives.
Monitor trends, identify issues, recommend and implement appropriate actions.
Maintain and/or approve GMP documentation at suppliers and within J&J, including supplier account records, audit records, investigations, and CAPAs.
Lead or serve on cross‑functional project initiatives to improve quality/compliance or achieve business goals.
Develop, implement, review, and approve SOPs associated with clinical packaging and labeling.
Oversee the batch record review process and monitor KPI status; collaborate with Clinical Supply Chain to resolve batch record discrepancies or errors per Good Documentation Practices.
Ensure manipulated drug products and finished products for clinical trials are released in accordance with cGMP and the product specification file in a timely manner.
Remain current with EMEA/FDA and local GMP regulations, guidelines, and quality practices.
Apply cGMP regulations and other international requirements to all aspects of the position.
Maintain compliance with all company policies and procedures.
Qualifications Education:
Minimum of a Bachelor's or equivalent University Degree in Science, Engineering, or Technical subjects preferred.
Required
Minimum of 8 years of experience in pharmaceuticals or an equivalent regulated environment.
Minimum of 4 years of experience within quality.
Excellent verbal and written communication skills, including effective communication with internal and external customers.
Excellent analytical skills to identify gaps and root causes of issues and to think creatively for solutions.
Ability to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Extensive knowledge and full understanding of Quality Assurance tasks associated with pharmaceutical manufacturing and packaging, release, and distribution processes.
Strong knowledge of cGMP, pharmaceutical legislation, regulations, and guidelines (e.g., US CFR, ICH, Eudralex volume 4‑annex 13).
Strong knowledge of required Quality and Production systems, including but not limited to TruVault and COMET.
Excellent computer proficiency (e.g., MS Office).
Strong understanding and experience in leading audits of external suppliers.
Ability to own and lead the resolution of complex Quality and Compliance issues regarding external manufacturing.
Basic to strong understanding of API and Finished Product Manufacturing.
Strong experience in leading, coaching, and developing a team.
Ability to handle multiple and/or complex stakeholders and priorities.
Fluent in written and spoken English.
Other Requirements Occasional travel to suppliers for audits and/or site visits (estimated 10‑15%).
Salary Transparency Base pay range: $100,000 – $173,500 USD.
Equal Opportunity Employer Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Accommodations Johnson & Johnson is committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please contact us via
https://www.jnj.com/contact-us/careers
or internal employees can contact their accommodation resource.
Benefits Employees are eligible to participate in company‑sponsored benefits programs including medical, dental, vision, life insurance, disability, accident insurance, and group legal insurance. Participation in the consolidated retirement plan (pension) and 401(k) savings plan is also available. Detailed benefit information can be found at
https://www.careers.jnj.com/employee-benefits .
#J-18808-Ljbffr
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.com .
Job Function Quality
Job Sub Function Quality Assurance
Job Category Professional
All Job Posting Locations Bridgewater, New Jersey; Horsham, Pennsylvania; Malvern, Pennsylvania; New Brunswick, New Jersey; Raritan, New Jersey; Spring House, Pennsylvania; Titusville, New Jersey.
Job Description Johnson & Johnson is currently recruiting for a
Manager External Clinical Supply Quality
position. This role can be located in New Jersey, Pennsylvania, or Beerse, Belgium.
Position Summary The Manager, External Clinical Supply Quality role is responsible for the quality and compliance in the selection, qualification, monitoring, and management of external suppliers used for the packaging, labeling, over-encapsulation, and distribution of investigational medicinal products. The individual will also support coaching and development within the team and pursue continuous improvement for proactive quality and business needs.
Key Responsibilities
Serve as a quality contact point for the External Manufacturer/Supplier regarding J&J product at the external facility and hold signatory authority for QA on those projects.
Support or lead qualification during selection and routine monitoring of suppliers, including leading clinical audits and negotiating quality agreements.
Contribute to the overall development, implementation, and execution of quality systems supporting external suppliers.
Provide cGMP compliance support by proactively managing quality using risk‑based approaches and investigating quality issues and product quality complaints.
Drive phase‑appropriate GMP implementation at external packaging and label suppliers to meet business requirements.
Build relationships and collaborate with suppliers and internal stakeholders to drive compliance and continuous improvement initiatives.
Monitor trends, identify issues, recommend and implement appropriate actions.
Maintain and/or approve GMP documentation at suppliers and within J&J, including supplier account records, audit records, investigations, and CAPAs.
Lead or serve on cross‑functional project initiatives to improve quality/compliance or achieve business goals.
Develop, implement, review, and approve SOPs associated with clinical packaging and labeling.
Oversee the batch record review process and monitor KPI status; collaborate with Clinical Supply Chain to resolve batch record discrepancies or errors per Good Documentation Practices.
Ensure manipulated drug products and finished products for clinical trials are released in accordance with cGMP and the product specification file in a timely manner.
Remain current with EMEA/FDA and local GMP regulations, guidelines, and quality practices.
Apply cGMP regulations and other international requirements to all aspects of the position.
Maintain compliance with all company policies and procedures.
Qualifications Education:
Minimum of a Bachelor's or equivalent University Degree in Science, Engineering, or Technical subjects preferred.
Required
Minimum of 8 years of experience in pharmaceuticals or an equivalent regulated environment.
Minimum of 4 years of experience within quality.
Excellent verbal and written communication skills, including effective communication with internal and external customers.
Excellent analytical skills to identify gaps and root causes of issues and to think creatively for solutions.
Ability to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.
Extensive knowledge and full understanding of Quality Assurance tasks associated with pharmaceutical manufacturing and packaging, release, and distribution processes.
Strong knowledge of cGMP, pharmaceutical legislation, regulations, and guidelines (e.g., US CFR, ICH, Eudralex volume 4‑annex 13).
Strong knowledge of required Quality and Production systems, including but not limited to TruVault and COMET.
Excellent computer proficiency (e.g., MS Office).
Strong understanding and experience in leading audits of external suppliers.
Ability to own and lead the resolution of complex Quality and Compliance issues regarding external manufacturing.
Basic to strong understanding of API and Finished Product Manufacturing.
Strong experience in leading, coaching, and developing a team.
Ability to handle multiple and/or complex stakeholders and priorities.
Fluent in written and spoken English.
Other Requirements Occasional travel to suppliers for audits and/or site visits (estimated 10‑15%).
Salary Transparency Base pay range: $100,000 – $173,500 USD.
Equal Opportunity Employer Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Accommodations Johnson & Johnson is committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please contact us via
https://www.jnj.com/contact-us/careers
or internal employees can contact their accommodation resource.
Benefits Employees are eligible to participate in company‑sponsored benefits programs including medical, dental, vision, life insurance, disability, accident insurance, and group legal insurance. Participation in the consolidated retirement plan (pension) and 401(k) savings plan is also available. Detailed benefit information can be found at
https://www.careers.jnj.com/employee-benefits .
#J-18808-Ljbffr