Manager, Supplier Quality, Drug Delivery Systems (DDS)

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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 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 Bachelors 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 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 :

$105000.00 - $181700.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys 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: Experience:

Manager