New · posted Nov 5
Johnson & Johnson · Pharmaceuticals
Manager, Supplier Quality, Drug Delivery Systems (DDS)
- Malvern, PA +3 more
- Hybrid
- Full-time
- Manager
The role
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.
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 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.
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.
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.
Other
- May require up to 20% of domestic travel.
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.
What you need
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.
Preferrednice to have
- 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).
Preferred Skillsnice to have
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
Pay and benefits
$105,000 – $181,700 a year
Employer providedThe anticipated base pay range for this position is
$105,000.00 - $181,700.00
Pension and 401(k) savings plan
Vacation (120 hours per year)
Sick time
13days
13 days holiday pay including floating holidays
Parental leave
Volunteer and caregiver leave
Where you'll work
Malvern, PA +3 moreHybridOpen in Maps (opens in a new tab)
Also posted for: Horsham, PA · Raritan, NJ · Titusville, NJ
More jobs in Malvern, PA +3 moreWorking conditions
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
From the posting
About Johnson & Johnson
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
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
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
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.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% below the US median for Supplier Quality roles at this level.
This roleEmployer provided
Manager roles in the US13 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $105,000 | — | $181,700 |
| All US (middle half) | $142,500 | $145,000 | $160,000 |
This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Supplier Quality roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Supplier Quality
The general path across 80 open Supplier Quality roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk13
- Collaboration and leadership7
- GMP and compliance6
- Investigations and CAPA3
- Validation and qualification3
- Lab testing and methods1
- Documentation and SOPs1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Supplier Quality work in pharmaceuticals, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality AgreementsNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- FDA21 CFR Part 4(official source, opens in a new tab)Current good manufacturing practice for combination productsNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
Company hiring pulse
Johnson & Johnson on Regulatory Jobs
- 39
- Open roles
- 39
- Distinct roles
- 17
- Locations
By discipline
- Quality20 51%
- Clinical11 28%
- Regulatory8 21%
By level
- Senior & Principal13 33%
- Manager12 31%
- Director7 18%
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Manager, Supplier Quality, Drug Delivery Systems (DDS) at Johnson & Johnson
Applications close November 11. $105K–$182K a year, employer provided.