Johnson & Johnson Innovative Medicine
Manager External Clinical Supply Quality
Johnson & Johnson Innovative Medicine, Spring House, Pennsylvania, United States, 19477
Manager External Clinical Supply Quality
Join to apply for the
Manager External Clinical Supply Quality
role at
Johnson & Johnson Innovative Medicine .
Work locations include Bridgewater, New Jersey; Horsham, Pennsylvania; Malvern, Pennsylvania; New Brunswick, New Jersey; Raritan, New Jersey; Spring House, Pennsylvania; and Titusville, New Jersey.
Position Summary The Manager, External Clinical Supply Quality 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. Additionally, the manager supports coaching and development within the team of employees and drives continuous improvement for proactive quality and business needs.
Key Responsibilities
Serve as the quality contact point for external manufacturers/suppliers and hold signatory authority for QA on projects.
Support or lead qualification during selection and routine monitoring of suppliers, including clinical audits and negotiation of quality agreements.
Contribute to the development, implementation, and execution of quality systems for external suppliers.
Provide cGMP compliance support by proactively managing quality and investigating quality issues and product complaints.
Drive phase‑appropriate GMP implementation at external packaging and label suppliers throughout development.
Build relationships and collaborate with suppliers and internal stakeholders to drive compliance and continuous improvement initiatives.
Monitor trends, identify issues, recommend actions, and implement appropriate solutions.
Maintain and approve GMP documentation at suppliers and within Johnson & Johnson, including account records, audit records, investigations, and CAPAs.
Lead or serve on cross‑functional teams or major projects to improve quality/compliance or achieve business goals.
Develop, implement, review, or approve SOPs related to clinical packaging and labeling.
Oversee batch record review and monitor KPI status, collaborating with Clinical Supply Chain to resolve discrepancies or errors related to Good Documentation Practices.
Ensure released drug products for clinical trials meet cGMP, product specifications, and are released in a timely manner to avoid patient or trial impact.
Stay current with EMEA/FDA and local GMP regulations, guidelines, and industry quality practices.
Apply cGMP and all regulatory requirements to all aspects of the role.
Maintain compliance with all company policies and procedures.
Qualifications Education A minimum of a bachelor’s degree or equivalent university degree, preferably in science, engineering, or technical subjects.
Required Qualifications
Minimum of 8 years of experience within pharmaceuticals or an equivalent regulated environment.
Minimum of 4 years of experience in quality functions.
Excellent verbal and written communication skills with internal and external customers.
Strong analytical skills to identify gaps and root causes, and to develop creative solutions.
Ability to work independently with minimal supervision to meet tight deadlines while maintaining a positive attitude.
Extensive knowledge of QA tasks in pharmaceutical manufacturing, packaging, release, and distribution processes.
Strong knowledge of cGMP, US CFR, ICH, Eudralex Volume 4 Annex 13, and related regulations.
Proficiency with quality and production systems such as TruVault and COMET.
Proficient in MS Office.
Experience leading audits of external suppliers.
Ownership and leadership in resolving complex quality and compliance issues with external manufacturing.
Basic to strong understanding of API and finished product manufacturing.
Experience in leading, coaching, and developing a team.
Ability to manage multiple stakeholders, priorities, and cross‑functional global teams.
Fluent in written and spoken English.
Other Requirements Occasional travel to supplier sites for audits and site visits, estimated at 10‑15 %.
Compensation Anticipated base pay range: $100,000‑$173,500 USD.
Benefits Employees and eligible dependents may participate in company‑sponsored benefit programs, including medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Eligible employees may also participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)).
Time‑off benefits: vacation 120 hours per calendar year; sick time 40 hours per calendar year (56 hours for Washington residents); holiday pay (including floating holidays) 13 days per calendar year; work, personal and family time up to 40 hours per calendar year; parental leave 480 hours within one year of birth/adoption/foster care of a child; condolence leave 30 days for an immediate family member, 5 days for extended family; caregiver leave 10 days; volunteer leave 4 days; military spouse time‑off 80 hours.
Additional information can be found at https://www.careers.jnj.com/employee-benefits.
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.
Johnson & Jonn is committed to providing an inclusive interview process for applicants with disabilities. If you are an individual with a disability and would like to request an accommodation, external applicants may contact us via https://www.jnj.com/contact-us/careers. Internal employees can contact AskGS to be directed to an accommodation resource.
#J-18808-Ljbffr
Manager External Clinical Supply Quality
role at
Johnson & Johnson Innovative Medicine .
Work locations include Bridgewater, New Jersey; Horsham, Pennsylvania; Malvern, Pennsylvania; New Brunswick, New Jersey; Raritan, New Jersey; Spring House, Pennsylvania; and Titusville, New Jersey.
Position Summary The Manager, External Clinical Supply Quality 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. Additionally, the manager supports coaching and development within the team of employees and drives continuous improvement for proactive quality and business needs.
Key Responsibilities
Serve as the quality contact point for external manufacturers/suppliers and hold signatory authority for QA on projects.
Support or lead qualification during selection and routine monitoring of suppliers, including clinical audits and negotiation of quality agreements.
Contribute to the development, implementation, and execution of quality systems for external suppliers.
Provide cGMP compliance support by proactively managing quality and investigating quality issues and product complaints.
Drive phase‑appropriate GMP implementation at external packaging and label suppliers throughout development.
Build relationships and collaborate with suppliers and internal stakeholders to drive compliance and continuous improvement initiatives.
Monitor trends, identify issues, recommend actions, and implement appropriate solutions.
Maintain and approve GMP documentation at suppliers and within Johnson & Johnson, including account records, audit records, investigations, and CAPAs.
Lead or serve on cross‑functional teams or major projects to improve quality/compliance or achieve business goals.
Develop, implement, review, or approve SOPs related to clinical packaging and labeling.
Oversee batch record review and monitor KPI status, collaborating with Clinical Supply Chain to resolve discrepancies or errors related to Good Documentation Practices.
Ensure released drug products for clinical trials meet cGMP, product specifications, and are released in a timely manner to avoid patient or trial impact.
Stay current with EMEA/FDA and local GMP regulations, guidelines, and industry quality practices.
Apply cGMP and all regulatory requirements to all aspects of the role.
Maintain compliance with all company policies and procedures.
Qualifications Education A minimum of a bachelor’s degree or equivalent university degree, preferably in science, engineering, or technical subjects.
Required Qualifications
Minimum of 8 years of experience within pharmaceuticals or an equivalent regulated environment.
Minimum of 4 years of experience in quality functions.
Excellent verbal and written communication skills with internal and external customers.
Strong analytical skills to identify gaps and root causes, and to develop creative solutions.
Ability to work independently with minimal supervision to meet tight deadlines while maintaining a positive attitude.
Extensive knowledge of QA tasks in pharmaceutical manufacturing, packaging, release, and distribution processes.
Strong knowledge of cGMP, US CFR, ICH, Eudralex Volume 4 Annex 13, and related regulations.
Proficiency with quality and production systems such as TruVault and COMET.
Proficient in MS Office.
Experience leading audits of external suppliers.
Ownership and leadership in resolving complex quality and compliance issues with external manufacturing.
Basic to strong understanding of API and finished product manufacturing.
Experience in leading, coaching, and developing a team.
Ability to manage multiple stakeholders, priorities, and cross‑functional global teams.
Fluent in written and spoken English.
Other Requirements Occasional travel to supplier sites for audits and site visits, estimated at 10‑15 %.
Compensation Anticipated base pay range: $100,000‑$173,500 USD.
Benefits Employees and eligible dependents may participate in company‑sponsored benefit programs, including medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Eligible employees may also participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)).
Time‑off benefits: vacation 120 hours per calendar year; sick time 40 hours per calendar year (56 hours for Washington residents); holiday pay (including floating holidays) 13 days per calendar year; work, personal and family time up to 40 hours per calendar year; parental leave 480 hours within one year of birth/adoption/foster care of a child; condolence leave 30 days for an immediate family member, 5 days for extended family; caregiver leave 10 days; volunteer leave 4 days; military spouse time‑off 80 hours.
Additional information can be found at https://www.careers.jnj.com/employee-benefits.
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.
Johnson & Jonn is committed to providing an inclusive interview process for applicants with disabilities. If you are an individual with a disability and would like to request an accommodation, external applicants may contact us via https://www.jnj.com/contact-us/careers. Internal employees can contact AskGS to be directed to an accommodation resource.
#J-18808-Ljbffr