Associate Director, Quality Assurance

Job Description

The Compliance and Quality Management Systems (CQMS) organization is part of the larger Global Development Quality (GDQ) organization within our Company's Research Laboratory Quality Assurance and is responsible for the execution of critical activities in the areas of compliance, quality systems, regulatory intelligence and the Quality Management System (QMS).

The Associate Director, Quality Systems is responsible for execution, oversight, and continuous improvement of globally governed quality system processes in support of the clinical supply chain for investigational medicinal product within our company's Global network. The position strengthens the effectiveness, consistency, and sustainability of deviation management, CAPA, change control, quality risk management, and data governance during a period of heightened regulatory focus and organizational transformation.

The responsibilities of this role included, but are not limited to:

• 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/ data integrity controls that underpin right-first-time execution and regulatory confidence.
• Provide quality system expertise to ensure processes remain in a state of control, 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 cross-functionally with site and functional teams to identify systemic gaps, influence adoption of global standards, and implement sustainable solutions.
• Support management oversight activities 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, providing interpretation and guidance to stakeholders.

Education Minimum Requirement:

• B.S., M.S., or Ph.D. in a science or engineering discipline.

Required Experience and Skills:

• Minimum 8 years (B.S./M.S.) or 5 years (Ph.D.) in the pharmaceutical or biotechnology industry.
• 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.

Preferred Experience and Skills:

• 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, with 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

#eligibleforERP

Required Skills:

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, Training and Development

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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 click here 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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

…