Head of Global Quality Systems

Merck•Rockville, MD

4d•Hybrid

About The Position

This leadership role is 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 procedures. The role involves the analysis, development, and operation of quality and risk management systems, including developing standards for quality, documentation, and processes, as well as continuous improvement and preventive activities. The Head of Global Quality Systems will direct the resolution of complex operational problems, lead the governance of core quality systems, and drive continuous improvement and harmonization of procedures across global sites. This position requires close collaboration across different geographies (US, EU, UK, APAC) and proactive engagement with key stakeholders to align with Quality strategies. The role ensures compliance to regulatory standards in the conduct and reporting of work, creates and manages plans to improve the quality culture with defined actions, timelines, and KPI reporting, and oversees the review and approval of quality system records such as deviations, investigations of Out of Specification (OOS) and anomalous results, and CAPA. The position also ensures robust investigations to identify root causes and drive continuous improvement, collaborates on risk-based strategies to identify, assess, and mitigate QMS risks, and participates in site readiness activities and quality systems support for client audits, internal audits, and regulatory inspections. Additionally, the role advocates for standardization of quality approaches and procedures globally and may participate in or lead other activities as required by Senior Management, including participation in meetings across different time zones. The role also includes managing resource and financial planning, and leading, training, and developing a high-performing team, including day-to-day management, setting objectives, coaching, performance appraisal, and recommending compensation.

Requirements

Bachelor’s degree in a scientific discipline.
10+ years working in a cGMP/GLP environment.
Experience in FDA/EMA or equivalent regulated industry such as pharmaceutical and biopharmaceutical, devices and diagnostics.
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.
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.
Must be eligible to work in the US.

Nice To Haves

Advanced degree preferred.
Certification in Lean Six Sigma and a Quality related area is beneficial.
Previous experience in a client facing Quality role is preferred.
Experience with regulated products or services across different geographies preferred.
Mastery in hosting regulatory inspections and managing responses.
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.

Responsibilities

Design, implement, maintain, and improve the Quality Management System (QMS).
Ensure compliance with GMP, GLP, ICH, ISO guidelines/standards, and other global regulatory requirements.
Analyze, develop, and operate quality and risk management systems.
Develop standards for quality, documentation, and processes.
Drive continuous improvement and preventive activities.
Direct the resolution of highly complex or unusual operational problems.
Lead the governance of core quality systems to ensure compliance with cGxP regulations, ICH and ISO guidelines, and Merck and LS standards and procedures.
Drive continuous improvement of quality systems and harmonize procedures across global sites.
Leverage collaboration across different geographies (US, EU, UK, APAC) and seek support from key stakeholders.
Ensure compliance to regulatory standards in the conduct and reporting of work.
Create, manage, and drive effective plans to improve the culture of quality with defined actions, timelines, and KPI reporting.
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.
Collaborate, identify, and implement risk-based strategies to identify, assess, and mitigate QMS risks.
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.
Participate in or lead other activities as required by Senior Management.
Manage resource and financial planning to ensure alignment with business needs and quality requirements.
Recruit, lead, train, and develop a high performing team.
Responsible for day-to-day management, setting objectives, coaching, developing employees, performance appraisal, and recommending employee compensation.