Associate Director Standards & Execution

About the role

The Associate Director, Standards & Execution is responsible for leading the planning, execution, and implementation of strategic initiatives that support the Global Regulatory and Clinical Safety (GRACS) Quality Management System (QMS). This role provides leadership and execution for key compliance programs, including GRACS Privacy, Data Security, and Records Management, ensuring alignment with corporate policies, regulatory requirements, and organizational objectives. The role partners closely with stakeholders across GRACS and enterprise functions to assess business needs, define requirements, and develop execution strategies that strengthen compliance, enhance operational effectiveness, and promote transparency across a globally distributed organization.

Responsibilities

• Lead the planning, coordination, and successful execution of assigned strategic initiatives, ensuring alignment with program objectives, sponsor expectations, and organizational priorities.
• Partner with project leaders to develop and manage project plans, governance structures, implementation activities, milestones, risks, and deliverables.
• Establish and lead the GRACS records management and document retention program, including development of associated standards, governance, processes, tools, and controls.
• Support the execution of the GRACS Data Security Program (DSP), including monitoring, reporting, documentation, and governance activities, with particular focus on sensitive data transfers and related compliance requirements.
• Support the GRACS Privacy Program by collaborating with business process owners to develop, maintain, and periodically assess privacy impact assessments and related compliance documentation.
• Coordinate and support annual privacy assessments and associated remediation activities across GRACS.
• Partner with stakeholders to ensure appropriate third-party due diligence processes are completed, documented, monitored, and renewed for both global and U.S.-based vendors and service providers.
• Drive continuous improvement of governance, compliance, and operational processes through effective stakeholder engagement, risk identification, and implementation of sustainable solutions.
• Provide leadership communications, metrics, and status reporting to support informed decision-making and business performance transparency.

Qualifications

Education

Minimum Requirement: Minimum 15+ years’ experience in project management, systems management and/or regulatory related experience or Bachelor’s Degree with a minimum of 8 years of project management, systems management and/or regulatory related experience or an advanced degree and a minimum of 4 years of project management and/or regulatory related experience.

Required Experience and Skills

• Excellent facilitation, complex project management, problem solving, and written and verbal communication skills, including presentations to senior management.
• Demonstrated experience in compliance, governance, privacy, data security, records management, or quality management systems.
• Ability to translate business requirements into practical execution plans and measurable outcomes.
• Strong stakeholder management, influence, and communication skills across all organizational levels.
• Experience working in a global, highly regulated environment preferred.
• Proven ability to lead multiple priorities while driving execution and delivering results.
• Ability to lead by influence and work effectively in matrix organizational structures.
• Process Management Knowledge (e.g., Green Belt).
• Good interpersonal and communication skills (in English, both verbal & written).
• Good negotiation skills with internal stakeholders.
• Strong analytical skills with a demonstrated ability to extensively analyze business processes and workflows.

Preferred Experience and Skills

• Demonstrated Change Management knowledge and experience in a wide range of projects.
• Lean Six Sigma and Change Management Certification.
• Demonstrated project management skill, knowledge, and application, including PMI/PMP Certification.

Required Skills

• Ability to Coordinate
• Business Alignment
• Business Decisions
• Change Management
• Compliance Requirements
• Cross-Functional Teamwork
• Document Control Systems
• Leadership Reporting
• Negotiation
• Process Analytics
• Project Leadership
• Project Management
• Project Planning
• Regulatory Compliance
• Regulatory Experience
• Stakeholder Management
• Strategic Thinking

Pay

The salary range for this role is $129,000.00 – $203,100.00. 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.

Benefits

• 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