Associate Director, Quality Systems- Hybrid

Job Description 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 products within the 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. 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. Establish and reinforce master data management and 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. Required Skills Audit Management Compliance Investigations Data Governance Data Integrity Deviation Management Global Program Development Good Manufacturing Practices (GMP) In Process Quality Control Master Data Management (MDM) Pharmaceutical Quality Assurance Pharmaceutical Quality Control (QC) Quality Assurance Systems Quality Operations Quality Oversight Quality Risk Assessment Quality Risk Management Quality Systems Compliance Quality Systems Documentation Regulatory Compliance Benefits The salary range for this role is $129,000.00 – $203,100.00. The successful candidate will be eligible for an annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits including medical, dental, vision, and other insurance benefits for employee and family; retirement benefits, including 401(k); paid holidays; vacation; and compassionate and sick days. For more information about benefits, please visit Equal Employment Opportunity 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 U.S. Equal Opportunity Employment laws, visit EEOC websites. #J-18808-Ljbffr Merck & Co.