R & D Quality Strategy Lead (Billerica MA)

EMD Serono, Inc.; Billerica (MA); On-site; USD 142,000 - 213,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Perquisites

Job summary

EMD Serono, Inc. in the United States is seeking a strategic R&D Quality Strategy Lead to drive quality strategy across development programs and ensure risk management and inspection readiness.

You will partner with cross-functional teams and senior leaders to embed quality into development decisions. The role emphasizes program quality governance, due diligence support, and continuous improvement, with on-site work in Billerica, MA.

Qualifications

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

Responsibilities

• Lead Program Quality Strategy and develop the quality strategy for assigned development programs.
• Define and oversee risk assessments, program audit strategy and QA activities.
• Provide quality expertise during due diligence and key business decisions.
• Support continuous improvement and quality-by-design approaches across programs.
• Drive risk mitigation strategies and oversee deviation management.
• Lead inspection preparedness activities and support health authority inspections.
• Monitor audits, track deliverables and promote consistent quality practices.
• Collaborate with Clinical Development, Regulatory Affairs, and other R&D functions.

Skills

Quality Assurance

GxP & regulations

Stakeholder management

Project leadership

Education

Bachelor's degree in science/quality

Tools

GxP systems

QA audit tools

Job description

Work Your Magic with us! Start your next chapter and join EMD Serono.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

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

• 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.

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.

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!