Manager, External Quality, External Contract Laboratories (ECL) Americas (MedTech)

Location: Horsham, PA; Malvern, PA; or Raritan, NJ, United States. Up to 20% global travel is required. Candidates must already have authorization to work in the United States; immigration sponsorship and relocation support are not available.

Base pay: $102,000–$177,100 per year.

Company

Johnson & Johnson MedTech develops healthcare and pharmaceutical solutions with a focus on innovation and patient outcomes.

What you will do

• Provide quality assurance, compliance, and technical support for external contract laboratories across North and Latin America.
• Lead end-to-end quality and compliance oversight, including laboratory qualification, supplier monitoring, and risk management.
• Conduct on-site and remote audits, develop corrective action plans, and resolve quality deficiencies.
• Manage deviations, corrective and preventive actions, quality systems, and timely closure of issues affecting release and stability.
• Develop, negotiate, execute, and maintain Quality Agreements with external contract laboratories.
• Coordinate cross-functional initiatives with Quality, Procurement, Analytical Development, Supply Chain, and laboratory stakeholders.

Requirements

• Bachelor’s degree or equivalent university degree; Engineering, Science, or a related technical discipline preferred.
• At least 6 years of experience in a pharmaceutical, medical device, or biotech regulated environment.
• At least 2 years of experience in pharmaceutical Quality Control, Analytical Development laboratories, or closely related work.
• Extensive experience in Quality Assurance, Quality Control, Compliance, auditing, and pharmaceutical QMS systems.
• Knowledge of FDA and EMA requirements applicable to biologics and pharmaceutical testing, plus the ability to provide cGMP compliance support.
• English proficiency is required, and candidates must already have U.S. work authorization.

Nice to have

• Quality Assurance and Quality Control experience.
• Experience with ISO 9001, quality validation, process improvement, and standard operating procedures.
• Strong negotiation, relationship-building, and technical communication skills.

Culture & Benefits

• Full-time employment within a global healthcare organization.
• Retirement pension and 401(k) savings plans, subject to plan terms.
• Vacation, sick time, holidays, parental leave, caregiver leave, bereavement leave, and volunteer leave.
• Inclusive workplace focused on diversity, dignity, and equal employment opportunity.
• Global collaboration with Quality, Procurement, Supply Chain, and laboratory teams.