Head of Global Quality Systems

Merck Group • $154K — $290K *
Rockville, MD 20850In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific discipline; advanced degree preferred.
  • 10+ years in cGMP/GLP regulated environments with quality improvement experience.
  • 8+ years in a leadership role within Quality Assurance in Life Sciences.
  • Strong relationship building and negotiation skills with client-facing experience preferred.
  • Knowledge of key regulatory standards, including 21 CFR, EU GMP, and ISO guidelines.
  • Expertise in managing quality system transformations, including CAPA and internal audits.
  • Fluent in written and spoken English is preferred.

Responsibilities

  • Design and implement quality management systems ensuring compliance with GMP, GLP, and other standards.
  • Drive continuous improvement and harmonization of quality procedures across global sites.
  • Collaborate with stakeholders across multiple geographies for alignment on quality strategies.
  • Oversee compliance in quality system documentation, including investigations and deviations.
  • Develop and manage plans improving the culture of quality within the organization.
  • Conduct thorough investigations to identify root causes of quality issues.
  • Implement risk-based strategies for quality management across the organization.

Benefits

  • Health insurance
  • Paid time off (PTO)
  • Retirement contributions
  • Performance-based bonuses
  • Professional development opportunities
Full Job Description
Your Role:

A leadership role responsible for designing, implementing, maintaining, and improving the Quality Management System (QMS) to ensure compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), applicable International Council for Harmonization (ICH) and International Organization for Standardization (ISO) guidelines/standards, other global regulatory requirements as outlined in the BioReliance Testing Services Global Quality Manual, and Merck and Life Science standards and procedure. Responsible for the analysis, development, and operation of quality and risk management systems. Activities include developing standards for quality, documentation, and processes as well as continuous improvement and preventive activities. Directs the resolution of highly complex or unusual operational problems applying advanced analytical thought.
  • Lead the governance of core quality systems to ensure they are compliant with cGxP regulations, applicable ICH and ISO guidelines, and Merck and LS standards and procedures
  • Drive continuous improvement of quality systems and harmonize procedures across global sites to enhance efficiency
  • Leverage close collaboration across different geographies (US, EU, UK, APAC) and proactively seek support from key stakeholders to obtain the required input and alignment with Quality strategies
  • Responsible for ensuring compliance to regulatory standards in the conduct and reporting of work performed
  • Create, manage, and drive effective plans to improve the culture of quality with defined actions, timelines, and KPI reporting to BioReliance CTS leadership, Quality and site leadership, or other Merck stakeholders as required
  • Ensure the review and approval of quality system records including deviations, investigations of Out of Specification (OOS) and anomalous results, CAPA, etc.
  • Ensure the robust conduct of investigations to identify root causes and drive continuous improvement across the organization
  • Collaborate, identify, and implement risk-based strategies to identify, assess, and mitigate QMS risks across the organization
  • Participate in site readiness activities and provide Quality Systems support in managing client audits, internal audits, and regulatory inspections
  • Advocate and drive standardization of quality approaches and procedures across the global quality framework where appropriate
  • Participate in or lead other activities as required by Senior Management. This will involve participation in meetings across different time zones


Financial Dimension:
  • Manage resource and financial planning to ensure alignment with business needs and quality requirements.


Management of People:
  • Recruit, lead, train, and develop a high performing team to respond to business demands while ensuring compliance to quality and regulatory requirements
  • Responsible for day-to-day management, setting objectives, coaching, developing employees, performance appraisal, and recommending employee compensation
  • Provides leadership and direction through supervisors/managers


Who You Are

Minimum Qualifications:
  • Bachelor's degree in a scientific discipline; advanced degree preferred
  • Certification in Lean Six Sigma and a Quality related area is beneficial
  • 10+ years working in a cGMP/GLP environment FDA/EMA or equivalent regulated industry such as pharmaceutical and biopharmaceutical, devices and diagnostics and a track record of quality improvement and execution
  • 8+ years of leadership experience in Quality Assurance in Bio/Pharmaceutical or Life Sciences industry
  • Strong relationship building and negotiation strategies, ability to influence, network, drive and manage change. Previous experience in a client facing Quality role is preferred
  • Working knowledge of 21 CFR 11, 58, 210 & 211, EU GMP, MHRA GLP & GMP, OECD GLP, ICH Q7, ISO 9001, and other applicable regulations, standards, and guidelines
  • Expertise in managing and leading the transformation of quality systems such as investigations of nonconformances including deviations and out of specification investigations, corrective actions and preventive actions (CAPA), effectiveness checks, management control, internal audits, and change controls
  • Experience with regulated products or services across different geographies preferred
  • Mastery in hosting regulatory inspections and managing responses


Preferred Qualifications:
  • Fluent in both written and spoken English
  • Excellent leadership & management skills
  • Excellent communication, interpersonal & conflict resolution skills
  • Excellent working knowledge of implementing, managing & applying QMS in a US/EU/APAC GxP environment
  • Leadership experience in building and/or enhancing quality systems such as investigations, change controls, etc.
  • Direct experience in communicating with regulatory authorities preferred
  • Leadership skills in managing change, attracting/developing talent, and coupling high performance standards with soft skills
  • Experience of managing a global operation preferred


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.

Keep Up to Date

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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

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