Senior Director, Head of Global Data Management and Standards (GDMS) Process & Quality Management - Hybrid

Job Description

Job Summary:

The Sr. Director and Head of GDMS Process and Quality Management is responsible for the development, implementation, oversight, and maintenance of the GDMS process and training compliance framework; business processes; associated functional process training; and quality management activities. Reporting to the Head of Global Data Management and Standards, sets the vision for the organization and is responsible for the timely and quality delivery of GDMS Process & Quality Management services. 

Responsibilities:

• Establishes and maintains the GDMS Process & Quality Management operating model, governance cadence, priorities, decision rights, and escalation pathways to drive consistent execution and accountability

• Serves as the Process Owner (PO) for all GDMS processes, oversights GDMS process development and maintenance, and directs the network of GDMS Sub- Process Owners (SPO) to ensure that business processes are effectively coordinated and aligned

• Partners with GDMS Business Operations and other stakeholders to align functional training strategy with process requirements and role expectations

• Ensures that GDMS process documentation and associated functional training is complete, aligned, of high quality, and compliant with regulatory requirements

• Ensures process changes are assessed for impact to documentation, role expectations, functional training requirements, and inspection readiness

• Engages with clinical programs and clinical trial teams to resolve escalated GDMS quality and compliance issues that are unable to be resolved at lower levels within the organization

• Serves as primary GDMS point of contact for audits and inspections, oversees GDMS responses, and ensures timely and effective CAPA management

• Serves as the "Center of Excellence" (COE) for business process management ensuring that inspection, audit, CAPA, and quality issue learnings are translated into sustainable process, training, documentation, and capability improvements

• Develops and monitors performance metrics, trends, and risk indicators to assess effectiveness, identify capability gaps, and drive continuous improvement

• Proactively engages with stakeholders, functional area leaders, quality and compliance organizations, and regulatory inspectors, ensuring that GDMS maintains high quality and complaint performance

• As a member of the GDMS Leadership team, actively contributes to organizational strategy, planning, and transformation

Additional Responsibilities:

• Strategy development, planning, and alignment with organizational goals and priorities
• Resource forecasting and management to ensure portfolio and other organizational objectives are met
• Leadership of talent development and performance management activities with a focus on building a high-performing team and fostering a culture of growth and development
• Oversight of financial forecasting, budget, and expense management
• Leadership engagement with internal stakeholders and industry leaders to identify opportunities for innovation and continuous improvement
• Ensuring process alignment with regulatory expectations and industry best practice
• Ensuring organizational awareness and compliance with company policies, procedures, mandatory training, and regulatory requirements (i.e., ICH, GCP)
• Sponsorship and/or leadership of organizational initiatives

Enterprise Leadership Skills:

• Strategic Planning –Thinks strategically and gains alignment through collaborative stakeholder engagement and influence across development, clinical operations, and quality organizations.
• Execution Excellence - Drives reliable, high‑quality delivery by establishing end‑to‑end processes and KPI‑driven measurement approaches to track progress, improve outcomes, and ensure consistent outputs
• Change Catalyst - Adapts to change and energizes teams through clear, compelling communication at all levels.
• Networking & Partnerships - Proactively builds and sustains strategic internal and external relationships (cross‑functional leaders, vendors, alliance partners, customers) to enable high quality and compliant delivery

Educational Requirements:

• Bachelor’s degree in life sciences, medicine, pharmacy, nursing, health informatics, or other healthcare- related field.

Preferred:

• Professional training or certification in clinical research and/or data management relevant disciplines including but not limited to: Association of Clinical Research Professional (ACRP) certification; SCDM Clinical Data Manager (CCDM) certification
• Professional training or certification in quality management, business process management, or Lean Six Sigma (eg., ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), ASQ Certified Quality Auditor (CQA), Lean Six Sigma black/green belt

Required Experience:

• 10+ years in clinical data management within the pharmaceutical or biotech industry.
• 5+ years directing or managing process and quality management operations.
• 5+ years of experience and demonstrated success in personnel management, including direct line management of managers or program managers in a matrixed, global organization.
• Experience managing, overseeing, and improving clinical data management processes across the full lifecycle (planning, start-up, conduct, close-out, archival).
• Experience preparing, leading and guiding program and study teams through audits, inspections, and CAPA management activities across therapeutic areas.
• Experience with using and/or managing data management and clinical trial technologies including those used by sponsors and vendors.

Required Knowledge, Skills and Abilities:

• Demonstrated knowledge of clinical development, clinical trial operations, clinical data management, and quality management processes
• Knowledge of clinical data standards and their use in clinical data management
• Well-versed in ICH-GCP and other regulatory requirements with particular focus on their application to clinical data management
• Familiarity with regulations in different countries (eg., FDA, EMA, MHRA, PMDA, Health Canada, and emerging markets)
• Working knowledge of risk-based approaches to clinical data management and adjacent clinical operations processes (ex., RBQM)
• Strong analytical and problem-solving ability with a pragmatic approach to balancing quality, compliance, timelines, and cost
• High integrity and a compliance-focused mindset
• Outstanding written and verbal communication skills, including ability to translate complex concepts into clear, concise, and actionable communications for non‑technical executives and cross‑functional stakeholders

clinicaltrialjobs

EligibleforERP

#GDMS

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.