Associate Director, Quality Control Device Quality & Regulatory

Associate Director, Quality Control – Device Quality & Regulatory

The Associate Director, Quality Control within our Research and Development Division Device Quality & Regulatory is responsible for providing QA/QC oversight of the company's Device Network design verification laboratories. This role will provide quality oversight for the qualification, calibration and maintenance of analytical laboratory instruments and equipment, method validation, and associated documentation for design verification laboratories in Rahway and the Center for Packaging & Device Analytics (CPDA).

• Serve as quality oversight for design verification laboratories.
• Oversight of qualification, maintenance and calibration of laboratory equipment, instrumentation and test methods used to support design verification.
• Provide quality approval for applicable equipment validation protocols and reports, test method validation protocols and reports, change controls, deviations and CAPA.
• Ensure procedures used by design verification laboratories align with Good Laboratory Practices, Good Documentation Practices, and applicable regulatory requirements.
• Provide support for internal audits and regulatory agency audits.
• Promote awareness of applicable regulatory requirements and QMS requirements for design verification laboratories.
• Ensure compliance with data integrity expectations.
• Lead implementation of ALCOA+ principles for data generated by the design verification laboratories.
• Support establishment of controls for computer system administration, data archival and data retention.
• Provide strategic direction, mentorship, and development opportunities to personnel.

• Bachelor of Science in relevant scientific discipline.
• 5 or more years of experience in quality laboratory operations.
• Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills.
• Familiarity with device design verification and design control aspects.
• Experience supporting internal and external audits.

• Biological Analysis
• Continuous Improvement Tools
• Counterfeit Detection
• Good Documentation Practices
• Good Laboratory Practices (GLPs)
• Identifying Customer Needs
• Internal Auditing
• Lab Equipment Maintenance
• Laboratory Analysis
• Laboratory Equipment Calibration
• Laboratory Operations
• Microbiological Analysis
• Proper Documentation
• Quality Control Management
• Quality Management
• Quantitative Assay
• Regulatory Awareness
• Regulatory Compliance
• Regulatory Requirements
• System Administration
• Technical Transfer
• Validation Protocols

• Current Employees apply here – (no application data needed for description).
• Current Contingent Workers apply here – (no application data needed for description).

$ - $

Effective September 5, 2023, employees in office-based positions in the U.S. will work a hybrid model consisting of three total days on-site per week, Monday–Thursday, with Friday designated as a remote‑working day, unless business‑critical tasks require on‑site presence. The hybrid model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions, collective‑bargaining‑agreement positions, or roles determined by the Company to require on‑site attendance.

We offer a comprehensive package of benefits, including medical, dental, vision, and other insurance benefits for employees and families, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Employment Opportunity laws, visit EEOC Know Your Rights, EEOC GINA Supplement, and other informational resources. We are committed to inclusion and encourage diverse perspectives.

You can apply for this role through  (or via the Workday Jobs Hub if you are a current employee). The Final date to receive applications for this position is stated on this posting.

Requisition : R378833