Associate Director, Quality Control Device Quality & Regulatory

Position: Associate Director, Quality Control - (Device Quality & Regulatory)
** Job Description
** 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).
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* Key responsibilities include:

**** 1. Serve as quality oversight for design verification laboratories:
*** Quality oversight for qualification, maintenance and calibration of laboratory equipment, instrumentation and test methods used to support design verification.
* Provides quality approval for applicable equipment validation protocols and reports, test method validation protocols and reports, change controls, deviations and CAPA.
* Ensures procedures used by design verification laboratories align with Good Laboratory Practices, Good Documentation Practices, and applicable regulatory requirements
* Provides support for internal audits and regulatory agency audits.
* Promotes awareness of applicable regulatory requirements and QMS requirements for design verification laboratories
** 2. Ensure compliance with data integrity expectations:
*** Leads implementation of ALCOA+ principles for data generated by the design verification laboratories
* Supports establishment of controls for computer system administration, data archival and data retention
** 3. Leadership and Personnel Management:
*** Provide strategic direction, mentorship, and development opportunities to personnel
** Required Education,

Experience and Skills:

*** 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
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* Required Skills:

** 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
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** US and Puerto Rico Residents Only:
** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment 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 applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

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** U.S. Hybrid Work Model
** Effective September 5, 2023, employees in office-based positions in the U.S. will be…