R & D Quality Strategy Lead (Billerica MA)

Work Location: Billerica, Massachusetts Shift: No Department: HC-RD-RFSN Development Unit N&I Recruiter: Rena Ann Peterson This information is for internals only. Please do not share outside of the organization. About the Role 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. Key Responsibilities 1. 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. 2. 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. 3. 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. 4. 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. 5. 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. Minimum Qualifications 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. Preferred Skills 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. Why Join Us? Shape quality strategy for innovative development programs. Partner with global cross-functional teams and senior leaders. Influence inspection readiness, compliance excellence, and continuous improvement initiatives. Make a meaningful impact on delivering high-quality medicines to patients worldwide. Location: On-site Billerica MA Pay Range for this position: $142,200 - $213,300 The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here . The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. #J-18808-Ljbffr Biopharma Careers