Senior Quality Assurance Manager

About the role

The Senior Quality Assurance Specialist leads global quality project and portfolio management efforts, ensuring that quality initiatives are planned, executed, and monitored effectively across a regulated, GxP environment. This role drives end-to-end delivery of global quality programs, enhances Quality Systems and integrations, and provides executive-level visibility into project performance.

Responsibilities

• Maintain and oversee global Quality project portfolios, ensuring visibility, alignment, and consistent execution across the network.
• Monitor project progress, proactively identify and manage risks and dependencies, and ensure initiatives are delivered on time and within defined scope.
• Drive end-to-end planning and execution of global quality initiatives, including developing detailed project plans, timelines, milestones, and resource management strategies.
• Collaborate closely with Project Leads and Quality Leadership to track progress, manage risks, and communicate outcomes across the organization.
• Capture, prioritize, and manage Quality Systems enhancements and platform integrations, ensuring timely and effective implementation.
• Facilitate regular project updates, steering committee meetings, quality forums, and executive-level reporting to keep stakeholders informed and aligned.
• Measure Quality project performance using appropriate systems, tools, and methodologies, including defining and tracking KPIs related to project success, quality impact, and operational outcomes.
• Leverage data-driven insights to inform decision making, drive continuous improvement, and support strategic quality objectives.
• Perform and assess project and quality risk management activities, escalating critical risks and mitigation strategies to leadership when necessary.
• Identify and implement opportunities for process efficiency, automation, and innovation across Quality initiatives.
• Apply Organizational Change Management strategies to support adoption, sustainability, and business readiness for new or enhanced Quality Systems and processes.
• Manage stakeholder relationships across all phases of the project lifecycle, engaging effectively with global, cross-functional partners.
• Guide and mentor junior Quality staff, fostering a culture of quality excellence, accountability, and continuous improvement.
• Stay current on industry trends, regulatory changes, and best practices to proactively enhance Quality Systems and processes.
• Balance competing priorities in a fast-paced environment while promoting a collaborative, trust-based culture and strong customer-service mindset.
• Communicate clearly and persuasively to Senior and executive audiences, providing strategic recommendations and influencing upwards.
• Support QA/QC initiatives and cross-functional quality transformations, ensuring alignment with broader organizational goals.
• Ensure project governance practices are followed, including structured executive reporting and KPI-driven performance management.

Requirements

• Strong knowledge of Quality Systems, quality principles, industry standards, and best practices in regulated GxP environments.
• GxP and Quality Systems experience within pharmaceutical, biotechnology, or medical device industries.
• At least 8 years of relevant industry experience in Quality, Quality Systems, Project Management, or regulated GxP environments, or at least 6 years with a related Master’s degree.
• Demonstrated global project and portfolio management experience, including executive-level reporting.
• Strong risk management capabilities, including identification, assessment, mitigation, and escalation of project and quality risks.
• Proven ability to define, track, and interpret KPIs related to project success, quality impact, and operational outcomes.
• Experience with stakeholder management practices and cross-functional leadership across global teams.
• Familiarity with project management tools and performance tracking systems used to manage complex initiatives.
• Excellent problem-solving and analytical skills, with strong attention to detail.
• Strong written and verbal communication skills, with the ability to present clearly to Senior and executive audiences.
• Demonstrated strength in planning, prioritization, and managing multiple initiatives simultaneously.
• Able to navigate ambiguity and translate complex initiatives into clear, actionable execution plans.
• Self-motivated, proactive, highly organized, and results-oriented with a strong sense of urgency.
• Comfortable balancing competing priorities in a fast-paced environment while fostering a collaborative culture.
• Customer-service mindset, focused on supporting internal stakeholders and delivering high-quality outcomes.
• Strategic mindset with the ability to connect project execution to broader organizational goals.
• Comfortable managing multiple priorities and deadlines concurrently.
• Strong problem-solving and troubleshooting abilities, particularly in complex, regulated environments.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Chemistry, Biology, or a related scientific discipline.
• Master’s degree in a related science, engineering, or quality discipline with at least 6 years of relevant industry experience.
• Demonstrated experience managing global Quality projects or portfolios in regulated pharmaceutical, biotech, or medical device environments.
• Experience supporting Quality Systems and QA/QC initiatives, as well as cross-functional quality transformations.
• Familiarity with project governance frameworks, executive reporting, and KPI-driven performance management.
• Project Management Professional (PMP) certification is a plus.
• Lean Six Sigma Green Belt certification is a plus.
• Highly organized with strong attention to detail and the ability to manage complex project documentation.
• Self-starter capable of working independently while maintaining strong alignment with stakeholders.
• Strong interpersonal and communication skills, with the ability to build trust-based relationships across functions and levels.
• Ability to communicate and influence upwards, providing strategic recommendations to leadership.

Skills

• Strong knowledge of Quality Systems, quality principles, industry standards, and best practices in regulated GxP environments.
• GxP and Quality Systems experience within pharmaceutical, biotechnology, or medical device industries.
• At least 8 years of relevant industry experience in Quality, Quality Systems, Project Management, or regulated GxP environments, or at least 6 years with a related Master’s degree.
• Demonstrated global project and portfolio management experience, including executive-level reporting.
• Strong risk management capabilities, including identification, assessment, mitigation, and escalation of project and quality risks.
• Proven ability to define, track, and interpret KPIs related to project success, quality impact, and operational outcomes.
• Experience with stakeholder management practices and cross-functional leadership across global teams.
• Familiarity with project management tools and performance tracking systems used to manage complex initiatives.
• Excellent problem-solving and analytical skills, with strong attention to detail.
• Strong written and verbal communication skills, with the ability to present clearly to Senior and executive audiences.
• Demonstrated strength in planning, prioritization, and managing multiple initiatives simultaneously.
• Able to navigate ambiguity and translate complex initiatives into clear, actionable execution plans.
• Self-motivated, proactive, highly organized, and results-oriented with a strong sense of urgency.
• Comfortable balancing competing priorities in a fast-paced environment while fostering a collaborative culture.
• Customer-service mindset, focused on supporting internal stakeholders and delivering high-quality outcomes.
• Strategic mindset with the ability to connect project execution to broader organizational goals.
• Comfortable managing multiple priorities and deadlines concurrently.
• Strong problem-solving and troubleshooting abilities, particularly in complex, regulated environments.

Benefits

Individual compensation offered for this position within the range of $69.00 - $80.00/hr. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)