Manager, Supplier Quality, Drug Delivery Systems (DDS)
About The Position
The Manager, Supplier Quality, Drug Delivery Systems (DDS) provides External Quality oversight for an assigned portfolio of suppliers of DDS components and devices used in combination products. The position manages day-to-day supplier relationships and partners with R&D, MSAT, Procurement, and internal manufacturing sites to carry out supplier qualification, quality and specification agreements, audits, change control, investigations, risk assessments, and performance monitoring in support of compliant products and a reliable supply chain. The manager owns supplier quality issue resolution for assigned suppliers through root cause analysis and corrective actions, executes risk mitigation plans, and supports supplier-site continuous improvement. Complex, multi-site, or high-risk issues are escalated to Senior Management. The role partners with R&D design teams to contribute supplier and manufacturing quality input on design specifications, material sourcing, and compliance considerations during design control. It also supports supplier risk management, proactive quality culture, and continuous improvement. The position may require up to 20% domestic travel and may be located in Malvern or Horsham, Pennsylvania, or Raritan or Titusville, New Jersey.
Requirements
- Bachelor’s degree; preferred subjects include science, engineering, or other technical areas.
- At least 6 years of experience in medical devices, combination products, biologics, drug products, drug substance, or a similar regulated environment.
- 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 ability to manage complexity within an assigned supplier portfolio.
- Excellent verbal and written communication skills, including effective communication with internal and external partners.
- Excellent computer proficiency, for example, MS Office.
- Some experience in Quality and Compliance is preferred.
Nice To Haves
- Experience with primary containers and medical devices.
- Experience with plastics injection or extrusion molding, device assembly manufacturing, and sterilization.
- Experience mentoring colleagues or directing contractors’ work; formal people management is not required.
Responsibilities
- Manage supplier relationships and provide External Quality oversight for an assigned portfolio of DDS component and device suppliers for combination products.
- Partner with 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.
- Work with R&D, MSAT, Procurement, internal IMSC sites, and other DDS development stakeholders on supplier quality activities, including quality and specification agreements, audits, supply chain identification, qualification, change control, investigations, risk assessments, performance monitoring, and complaints.
- Own resolution of supplier quality issues by coordinating root cause analysis and failure investigations, implementing corrective actions, and verifying their effectiveness.
- Execute supplier risk management by identifying high-risk process areas, implementing and monitoring mitigation plans, contributing to supplier risk management projects, and escalating risks requiring leadership decisions or cross-site alignment.
- Support supplier-site continuous improvement by identifying process variation, implementing process controls to improve capability, and applying best practices.
- Support issues involving DDS suppliers within the assigned scope and escalate complex, multi-site, or high-risk issues to Senior Management, ensuring timely mitigation of quality-related aspects.
Benefits
- Company consolidated retirement plan (pension), subject to the terms of the plan.
- 401(k) savings plan, subject to the terms of the plan.
- Vacation: 120 hours per calendar year.
- Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
- 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, or foster care of a child.
- Bereavement leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
- Caregiver leave: 80 hours in a 52-week rolling period.
- Volunteer leave: 32 hours per calendar year.
- Military spouse time-off: 80 hours per calendar year.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
