Associate Director, Quality Assurance
About The Position
The Compliance and Quality Management Systems (CQMS) organization is part of Global Development Quality within Research Laboratory Quality Assurance. It executes activities involving compliance, quality systems, regulatory intelligence, and the Quality Management System (QMS). The Associate Director, Quality Systems is responsible for executing, overseeing, and continuously improving globally governed quality system processes supporting the clinical supply chain for investigational medicinal products across the company's global network. The role strengthens the effectiveness, consistency, and sustainability of deviation management, CAPA, change control, quality risk management, and data governance amid heightened regulatory focus and organizational transformation. The position is based primarily in Rahway, New Jersey, with a hybrid work arrangement and 10% travel.
Requirements
- B.S., M.S., or Ph.D. in a science or engineering discipline.
- At least 8 years of experience in the pharmaceutical or biotechnology industry with a B.S. or M.S., or at least 5 years with a Ph.D.
- Demonstrated experience in Quality Systems, Quality Assurance, Compliance, or related GxP-regulated roles.
- Extensive working knowledge of global GxP requirements and Pharmaceutical Quality System principles.
- Skills in compliance investigations, data integrity, deviation management, Good Manufacturing Practices (GMP), managing ambiguity, process standardization, project leadership, Quality Assurance systems, quality compliance, quality oversight, quality risk management, quality systems compliance, and training and development.
Nice To Haves
- Proven ability to drive continuous improvement and standardization across complex quality systems.
- Strong analytical, problem-solving, and decision-making skills.
- Effective oral and written communication skills, including the ability to influence across organizational boundaries.
- Experience working within globally governed models and partnering with site and functional stakeholders.
- Ability to manage ambiguity while maintaining rigor, consistency, and control.
- Effective negotiation skills and project management abilities.
Responsibilities
- Drive Quality Systems Transformation initiatives focused on deviation management, CAPA effectiveness, change management, quality risk management, and data governance.
- Strengthen standardization and continuous improvement of global quality system processes to ensure consistent application, transparency, and inspection readiness.
- Reinforce data governance and data integrity controls that support right-first-time execution and regulatory confidence.
- Provide quality system expertise to keep processes in a state of control and compliant with global regulatory requirements and internal standards.
- Act as a change agent to enable durable quality system and quality culture improvements through system-level rigor, governance, and traceability.
- Partner with site and functional teams to identify systemic gaps, influence adoption of global standards, and implement sustainable solutions.
- Support management oversight by developing and monitoring quality system metrics and key performance indicators.
- Author, review, and approve quality system documentation and governance materials in accordance with established procedures.
- Maintain expert-level knowledge of GxP requirements, regulatory expectations, and industry trends, and provide interpretation and guidance to stakeholders.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including a 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Eligibility for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Director
