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 drug delivery system components and devices used in combination products. The role manages day-to-day supplier relationships and partners with Research & Development (R&D), MSAT, Procurement, and internal manufacturing sites to support compliant, high-quality products and a reliable supply chain. The manager oversees supplier qualification, quality and specification agreements, audits, change control, investigations, risk assessments, performance monitoring, and complaints. They own the resolution of supplier quality issues for assigned suppliers through root cause analysis, failure investigations, corrective actions, and effectiveness verification. The role also 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 position may require up to 20% domestic travel and can be based 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 the ability to communicate effectively with internal and external partners.
- Excellent computer proficiency, such as with MS Office.
Nice To Haves
- Experience in Quality and Compliance.
- 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.
- 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.
- Partner with R&D, MSAT, Procurement, internal IMSC sites, and other DDS development stakeholders to execute supplier quality management activities, including quality and specification agreements, audits, supply chain identification, supplier qualification, change control, investigations, risk assessments, performance metric reviews, and complaints.
- Own the resolution of supplier quality issues, including 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 a proactive quality culture and continuous improvement at suppliers by identifying process variation, implementing process controls to improve capability, and applying best practices.
- Support issues related to DDS suppliers within the assigned scope.
- Escalate complex, multi-site, or high-risk issues to Senior Management and ensure timely mitigation of the quality components of escalations.
- Travel domestically, as required, up to 20%.
Benefits
- Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
- Vacation: 120 hours per calendar year, subject to policy and date of hire.
- Sick time: 40 hours per calendar year, subject to policy and date of hire; different allotments apply to 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
