Associate Director of Quality Control

We are seeking a highly motivated and hands-on Associate Director of Quality Control to lead the establishment and ongoing management of a brand-new Quality Control laboratory at our Waverly, PA facility. This is a unique opportunity to build a QC function from the ground up and play a critical leadership role in developing the company’s first fully integrated onsite analytical testing program across multiple manufacturing facilities.

The Associate Director will lead laboratory start-up activities including equipment qualification and validation, method development and validation, SOP creation, laboratory process implementation, and team development. In the initial phase, this role will be highly technical and operational, including direct execution of analytical testing such as HPLC analysis until the laboratory team is staffed.

This position will oversee QC laboratory operations and broader QC functions across three manufacturing facilities and will partner cross-functionally with Operations, R&D, Regulatory, Engineering, and Quality Assurance to establish scalable, compliant, and efficient quality systems.

Essential Duties and Responsibilities:

Laboratory Start-Up & Technical Leadership

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Lead the start-up and operationalization of a new Quality Control laboratory at the Waverly, PA facility.

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Manage installation, qualification, calibration, and validation of laboratory instrumentation and equipment.

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Develop, optimize, validate, and transfer analytical methods for raw materials, in-process materials, finished products, and stability testing.

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Perform and oversee analytical testing including HPLC, wet chemistry, and other instrumental analyses as needed during early-stage laboratory operations.

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Establish laboratory workflows, specifications, documentation practices, and data integrity controls.

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Develop laboratory SOPs, forms, protocols, and training materials.

Quality Control Operations

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Direct QC activities across three manufacturing facilities.

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Ensure compliance with applicable cGMP, FDA, OTC, cosmetic, and medical device requirements.

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Review and approve laboratory investigations, OOS/OOT investigations, deviations, CAPAs, and change controls related to QC.

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Establish KPIs and metrics to monitor laboratory and QC performance.

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Support internal audits, regulatory inspections, and customer audits.

Stability Program Development

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Design and implement a company-wide stability program.

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Establish stability protocols, chamber management practices, sampling plans, and reporting processes.

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Lead the transition of stability testing from external laboratories to internal operations.

Team Leadership & Development

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Recruit, train, mentor, and develop QC laboratory personnel.

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Initially oversee 5 direct reports

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1 Chemist (Waverly, PA)

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1 Laboratory Technician (Waverly, PA)

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3 Quality Supervisors (Waverly, PA, Orangeburg, NY, Hudson, NY)

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Foster a culture of accountability, continuous improvement, and scientific rigor.