Director of Quality

Merck Group$154K — $290K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Applied Engineering, Sciences, or a related field
  • 8+ years of relevant quality management experience in a regulated manufacturing environment
  • Advanced degree in a relevant scientific or engineering discipline (preferred)
  • Professional certifications in quality or regulatory frameworks such as Six Sigma Black Belt, ASQ, GMP, GLP, or GxP (preferred)
  • Proven track record with quality management systems including ISO 9001, ICH Q9, GMP (preferred)
  • Experience in risk management, CAPA processes, and continuous improvement methodologies (preferred)
  • Familiarity with material analysis tools and validation processes (preferred)

Responsibilities

  • Own and shape the quality agenda for the Life Science manufacturing site
  • Lead and manage a team of quality professionals to enhance compliance
  • Drive strategic direction and execution across quality assurance and quality control
  • Ensure quality is integrated into all operational stages from supplier qualification to customer resolution
  • Oversee regulatory compliance and site audit readiness
  • Champion digital initiatives to improve data integrity and operational efficiency
  • Collaborate with production and commercial functions to influence performance metrics

Benefits

  • Health insurance
  • Paid time off (PTO)
  • Retirement contributions
  • Performance-based bonuses
  • Additional perquisites
Full Job Description
Your Role

Quality is not a checkpoint - it is the foundation on which scientific progress is built. As Director of Quality, you will own and shape the full quality agenda for a dynamic Life Science manufacturing site, driving both strategic direction and day-to-day execution across quality assurance and quality control. In this pivotal leadership role, you will set the quality vision, embed a proactive quality culture across the site, and serve as a senior member of the site leadership team. You will lead a team of quality professionals, oversee regulatory compliance, manage the quality budget, and champion digital initiatives that strengthen data integrity and operational efficiency. You will partner closely with production, technical services, and commercial functions to ensure that quality is integrated into every stage of operations - from supplier qualification and environmental monitoring through to product release and customer complaint resolution. Your leadership will directly influence site performance metrics, audit readiness, and the continuous improvement agenda, making a measurable impact on both compliance outcomes and customer satisfaction.

Who You Are

Minimum Qualifications:
  • Bachelor's degree in Engineering, Applied Engineering, Sciences, or related field
  • 8 or more years of relevant experience in quality management within a regulated manufacturing environment


Preferred Qualifications:
  • Advanced degree in a relevant scientific or engineering discipline
  • Demonstrated leadership in quality management, including talent development and building high-performing teams
  • Professional certifications in quality or regulatory frameworks such as Six Sigma Black Belt, ASQ, GMP, GLP, or GxP
  • Proven track record with quality management systems including ISO 9001, ICH Q9, GMP, and experience with FDA and EMA inspections
  • Experience in risk management, deviation handling, CAPA processes, and continuous improvement methodologies
  • Expertise in audits, supplier quality management, and quality metrics analysis
  • Familiarity with material analysis tools such as FTIR, DSC, microscopy, particle counters, and integrity testing
  • Understanding of validation and qualification processes, FMEA, SPC, sampling plans, and change control in regulated environments
  • Experience with electronic quality management systems, ERP platforms, and audit management tools
  • Proficiency in Microsoft Office and collaboration tools including Word, Excel, PowerPoint, Teams, and SharePoint


US Base Pay Range for this position - $154,700 - $290,300

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.

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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.
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