R & D Quality Strategy Lead (Billerica MA)

Merck•Billerica, MA

6d•Onsite

About The Position

As the R&D Quality Strategy Lead, you will serve as the quality partner for strategic development programs, driving quality strategy, risk management, inspection readiness, and compliance oversight across the product lifecycle. You will collaborate closely with cross-functional teams and senior stakeholders to ensure quality is embedded into development activities and decision-making.

Requirements

Bachelor's degree in a scientific or quality-related field required; advanced degree preferred.
Minimum 10 years of experience in Quality Assurance or a related pharmaceutical/biotech field.
Strong knowledge of drug development processes and global GCP regulations.

Nice To Haves

Strong stakeholder management, communication, and influencing skills.
Demonstrated ability to lead complex projects in a matrix environment.
Expertise in Quality Assurance, auditing, risk-based quality management, and root cause analysis.
Strong analytical and strategic mindset with the ability to drive business-focused quality solutions.
Experience across multiple GxP areas and global development programs preferred.

Responsibilities

Lead Program Quality Strategy: Develop and implement the quality strategy for assigned development programs. Define and oversee risk assessments, program audit strategy and other QA activities. Provide quality expertise during due diligence and key business decisions. Support continuous improvement and quality-by-design approaches across programs.
Manage Risk and Compliance: Identify emerging quality risks, trends, and gaps. Drive risk mitigation strategies and oversee deviation management. Escalate significant quality issues, potential misconduct, or compliance concerns to leadership, including coordination of serious breach assessment boards. Support root cause investigations and corrective actions when required.
Drive Inspection and Audit Readiness: Lead inspection preparedness activities across assigned programs. Support health authority inspections from preparation through close-out. Monitor audit activities, track deliverables, and promote consistent quality practices.
Influence and Partner Across the Organization: Collaborate with Clinical Development, Data Management, Biostatistics, Regulatory Affairs, and other R&D functions. Engage with external partners, vendors, investigational sites, and regulatory authorities. Provide quality insights and key compliance metrics to support strategic decision-making. Share best practices and promote a strong quality culture across the organization.
Champion Continuous Improvement: Enhance quality procedures, guidance documents, and audit tools. Stay current with industry trends, regulations, and emerging technologies. Identify opportunities to strengthen clinical trial oversight and operational excellence.