R & D Quality Strategy Lead (Billerica MA)

Merck Group • $142K — $213K *
Billerica, MA 01821In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

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
  • Expertise in auditing and risk-based quality management
  • Demonstrated leadership in complex project environments

Responsibilities

  • Develop and implement quality strategy for development programs
  • Oversee risk assessments and quality audit strategies
  • Provide quality insights during due diligence and business decisions
  • Lead inspection preparedness and support health authority inspections
  • Collaborate with various R&D functions and external partners
  • Enhance quality procedures and stay current with industry trends
  • Identify opportunities for continuous improvement in clinical trial oversight

Benefits

  • Opportunity to shape quality strategy for innovative programs
  • Engagement with global cross-functional teams and leadership
  • Influence compliance and continuous improvement initiatives
  • Make a meaningful impact on patient outcomes through high-quality medicines
Full Job Description
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.

About Merck Group

Merck Group Careers

There has never been a more opportune time to join Merck Group, a leading science and technology company in healthcare, life science, and performance materials. Merck Group offers a plethora of job opportunities that cater to a variety of skills and professional aspirations, making it an ideal environment for both seasoned experts and those at the start of their career journey.

Work You’ll Do

At Merck Group, every team member contributes to breakthrough innovations in healthcare, life sciences, and electronics. The company's commitment to diversity and innovation fuels its leadership in various sectors, driving growth and transformation globally. Merck Group’s career paths are diverse, offering positions that challenge individuals to use their skills in new ways every day, supported by robust training programs and development opportunities.

Explore Job Opportunities and Growth

Merck Group is not just about jobs; it's about building a career. With a vast array of positions, from research and development to marketing and sales, the company is keen on hiring and nurturing talent to lead industry transformation. Merck Group’s dedication to professional growth is evident in its comprehensive benefits package and performance management processes that aim to maximize individual potential.

Internship Programs

Starting with an internship at Merck Group can be a pivotal step in securing a prosperous career. Interns gain invaluable industry experience, working alongside seasoned professionals and engaging in projects that offer real-world applications of their studies. Internships often lead to full-time employment opportunities, providing a seamless transition from education to professional employment.

Inclusive Culture and Leadership

Merck Group is proud of its inclusive culture that embraces diversity and fosters an environment where all employees can thrive. The company’s leadership is committed to creating a workplace where diverse ideas lead to innovative outcomes. Merck Group also offers diversity training to ensure all team members are equipped to contribute to the company’s inclusive goals.

Networking and Professional Development

Employees at Merck Group are encouraged to engage in networking and professional development activities that enhance their career trajectories. The company hosts various networking events, workshops, and seminars that are designed to hone skills and foster connections within the industry. Leadership development programs are also a cornerstone, preparing employees for future roles of increased responsibility.

Stay Connected with Merck Group Careers

Interested candidates can explore open positions that match their skills and interests through the Merck Group careers page. The company values curious, creative, and solution-driven team players who are eager to make an impact.

Keep Up to Date

Stay informed with career tips, insider perspectives, and industry-leading insights from Merck Group professionals. These resources are invaluable for those looking to advance their careers and stay ahead in a competitive job market.

Job Alert Emails

Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences from Merck Group. Discover the exciting and rewarding career opportunities that await.

SEARCH MERCK GROUP JOBS

READ CAREERS BLOG

Merck Group is continuously looking for individuals who are ready to drive innovation and lead in the global marketplace. Whether through full-time positions, internships, or leadership roles, Merck Group offers a career path filled with opportunities for growth, learning, and leadership.
Learn more about Merck Group
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Merck Group

More Pharmaceuticals & Biotech Jobs

Find similar R & D Quality Strategy Lead (Billerica MA) jobs:

NationwideBillerica, MA