Manager, Supplier Quality, Drug Delivery Systems (DDS)

Johnson & Johnson Co.; Malvern (Chester County); Hybrid; USD 105,000 - 182,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Supplier Quality for Drug Delivery Systems to oversee External Quality for a portfolio of DDS suppliers. Location options include Malvern, Horsham, Raritan, or Titusville, with a hybrid work model.

You will collaborate with R&D, MSAT, Procurement, and internal manufacturing to qualify suppliers, draft quality and specification agreements, perform audits, change controls, investigations, and risk assessments to ensure compliant, high-quality products and a

Qualifications

• A minimum of a Bachelor’s degree; preferred subjects include Science, Engineering, or technical areas.
• A minimum of 6 years’ experience in medical devices, combination products, biologics, drug products, drug substance, or a similar regulated environment; some experience in Quality and Compliance preferred.
• Working knowledge of global cGMP requirements, ISO 13485, FDA 21 CFR Part 820, and regulatory requirements for combination product development.
• Experience and knowledge in device component design and/or combination product design and commercialization.
• Demonstrated experience managing external business partners or suppliers.
• Demonstrated problem-solving skills and the ability to manage complexity within an assigned supplier portfolio.
• Excellent verbal and written communication skills, including the ability to communicate effectively with internal and external partners.
• Excellent computer proficiency, for example MS Office.
• Preferred: Experience with primary containers and medical devices.
• Experience with plastics injection/extrusion molding, device assembly manufacturing, and sterilization.

Responsibilities

• Manages supplier relationships and provides External Quality oversight for an assigned portfolio of suppliers of Drug Delivery System (DDS) components and devices of combination products to support quality, compliant products and supply chain reliability.
• Partners with Research & Development (R&D) technical and quality design teams to provide supplier and manufacturing quality input on design specifications, material sourcing, and compliance considerations during design control.
• Partners with R&D, MSAT, Procurement, Internal IMSC sites, and other DDS development stakeholders to execute Supplier Quality Management activities for assigned suppliers, including quality agreements, specification agreements, audits, supply chain identification, qualification, change control, investigations, risk assessments, review of performance monitoring metrics, and complaints.
• Owns the resolution of supplier quality issues for assigned suppliers. This includes working with suppliers and internal stakeholders to perform root cause analysis and failure investigations, implementing corrective actions, and verifying effectiveness.
• Executes supplier risk management for assigned suppliers. This includes working with suppliers to identify high-risk process areas, implementing and monitoring risk mitigation plans, contributing to supplier risk management projects, and escalating risks that need leadership decisions or cross-site alignment.
• Supports a proactive quality culture and continuous improvement at assigned suppliers. This includes working with suppliers to identify sources of process variation, implementing process controls to improve capability, and applying best practices.

Skills

Supplier management

Quality systems

Root cause analysis

Regulatory knowledge

Communication

Education

Bachelor's degree in Science/Engineering/technical

Tools

MS Office

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality

Job Sub Function: Supplier Quality

Job Category: Professional

All Job Posting Locations: Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America

Job Description: We are searching for the best talent for Manager, Supplier Quality, Drug Delivery Systems (DDS), to be located in either Malvern, PA; Horsham, PA; Raritan, NJ or Titusville, NJ.

About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

Purpose: The Manager, Supplier Quality, Drug Delivery Systems provides External Quality oversight for an assigned portfolio of suppliers of drug delivery system (DDS) components and devices used in combination products. This role manages day-to-day supplier relationships and partners with R&D, MSAT, Procurement, and internal manufacturing sites to execute supplier qualification, quality and specification agreements, audits, change control, investigations, risk assessments, and performance monitoring in support of compliant, high-quality products and a reliable supply chain. The Manager owns the resolution of supplier quality issues for assigned suppliers through root cause analysis and corrective actions, executes supplier risk mitigation plans, and supports continuous improvement at supplier sites. Complex, multi-site, or high-risk issues are escalated to Senior Management. The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

You will be responsible for:

• Manages supplier relationships and provides External Quality oversight for an assigned portfolio of suppliers of Drug Delivery System (DDS) components and devices of combination products to support quality, compliant products and supply chain reliability.
• Partners with Research & Development (R&D) technical and quality design teams to provide supplier and manufacturing quality input on design specifications, material sourcing, and compliance considerations during design control.
• Partners with R&D, MSAT, Procurement, Internal IMSC sites, and other DDS development stakeholders to execute Supplier Quality Management activities for assigned suppliers, including quality agreements, specification agreements, audits, supply chain identification, qualification, change control, investigations, risk assessments, review of performance monitoring metrics, and complaints.
• Owns the resolution of supplier quality issues for assigned suppliers. This includes working with suppliers and internal stakeholders to perform root cause analysis and failure investigations, implementing corrective actions, and verifying effectiveness.
• Executes supplier risk management for assigned suppliers. This includes working with suppliers to identify high-risk process areas, implementing and monitoring risk mitigation plans, contributing to supplier risk management projects, and escalating risks that need leadership decisions or cross-site alignment.
• Supports a proactive quality culture and continuous improvement at assigned suppliers. This includes working with suppliers to identify sources of process variation, implementing process controls to improve capability, and applying best practices.
• Supports issues related to DDS suppliers under scope of responsibility. Escalates complex, multi-site, or high-risk issues (for example, those requiring L2, PAM, or QRB review) to Senior Management and ensures timely mitigation of the quality components of the escalation.

Qualifications/Requirements:

• A minimum of a Bachelor’s degree; preferred subjects include Science, Engineering, or technical areas.
• A minimum of 6 years’ experience in medical devices, combination products, biologics, drug products, drug substance, or a similar regulated environment; some experience in Quality and Compliance preferred.
• Working knowledge of global cGMP requirements, ISO 13485, FDA 21 CFR Part 820, and regulatory requirements for combination product development.
• Experience and knowledge in device component design and/or combination product design and commercialization.
• Demonstrated experience managing external business partners or suppliers.
• Demonstrated problem-solving skills and the ability to manage complexity within an assigned supplier portfolio.
• Excellent verbal and written communication skills, including the ability to communicate effectively with internal and external partners.
• Excellent computer proficiency, for example MS Office.
• Preferred: Experience with primary containers and medical devices.
• Experience with plastics injection/extrusion molding, device assembly manufacturing, and sterilization.
• Experience mentoring colleagues or directing the work of contractors (formal people management is not required).
• Other: May require up to 20% of domestic travel.

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 & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

• AI Judgement Integration
• Coaching
• Collaboration
• Compliance Management
• Controls Compliance
• Performance Measurement
• Process Improvements
• Product Testing
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Validation
• Relationship Building
• Stakeholder Engagement
• Standard Operating Procedure (SOP)
• Technical Credibility
• Vendor Selection

The anticipated base pay range for this position is : $105,000.00 - $181,700.00

Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year 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 the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/. Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.

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