Director, US Quality (Analytical Technical Solutions) Lead

Merck•Millsboro, DE
•$156,900 - $247,000•Hybrid

About The Position

The Director ATS (Analytical Technical Solutions) US Lead shapes the manufacturing and testing organization in alignment with company strategy. As a member of the global ATS leadership team, the role collaborates with partners across involved organizations and contributes to planning and executing the regional company strategy. The role manages and develops the team and oversees strategic planning and execution of the ATS project portfolio across multiple sites and platforms. It provides guidance and leadership, participates in governance, and assures progress and deliverables against company priorities and programs. The position requires an end-to-end understanding of pharmaceutical manufacturing, including operational, process, analytical, supply, financial, and other dependencies. The role owns, oversees, and reports on analytical activities undertaken by the team. The position is based primarily in De Soto, Kansas, with hybrid work arrangements and 25% travel. Domestic relocation is offered. The role is a regular, first-shift position; visa sponsorship is not available.

Requirements

  • Bachelor's degree in analytical, pharmaceutical, biopharmaceutical, biological, or analytical science, or equivalent job experience.
  • 10–15 years of experience in research, manufacture, and testing of pharmaceutical and/or biological products, including sound knowledge of key analytical technologies.
  • Experience in method development and validation, method robustness, and method transfer.
  • In-depth experience and a proven track record shaping, developing, and leading multiple teams and employees in matrix organizations.
  • Strong background in project execution and demonstrated leadership skills.
  • Ability to lead and drive multifaceted projects in a complex environment.
  • Communication, networking, and behavioral skills appropriate to the position.
  • Ability to advocate, lobby, and build alliances across the organization.
  • End-to-end understanding of pharmaceutical business processes and holistic thinking.
  • Flexibility in working schedules and willingness to travel.
  • Required skills include analytical method development, analytical thinking, cGMP compliance, decision making, driving continuous improvement, execution excellence, people leadership, pharmaceutical quality control, stakeholder management, and technology transfer.
  • Valid driving license.

Nice To Haves

  • Master's degree.
  • Regulatory compliance.

Responsibilities

  • Manage, plan, shape, and develop the organization.
  • Plan organizational needs and capabilities to meet business requirements in alignment with partners and the role's lead.
  • Plan staffing and budgets, select and hire team members, establish reporting and team governance, and develop and coach employees.
  • Coordinate execution of the analytical project portfolio, including cross-functional alignment, metrics, and reporting.
  • Set targets, deliver milestones, and report progress in tier and governance meetings.
  • Monitor the quality and timeliness of deliverables, identify portfolio gaps and needs, and mitigate issues or drive their resolution.
  • Build relationships with key partners and internal customers and serve as a clear, visible contact for analytical topics.
  • Understand colleagues' business priorities and needs, manage expectations, and provide transparency about work prioritization and timelines.
  • Represent the team and its progress in senior leader meetings and recommend direction.
  • Gather customer feedback and translate it into actionable insights to improve the organization.
  • Develop and report team performance metrics for inline analytical support, method remediation, robustness and improvement, site-to-site transfers, and new product commercialization transfers.
  • Align team priorities with local Site Management, Quality Operations, and Regional Heads at regional sites.

Benefits

  • Medical, dental, and vision healthcare benefits and other insurance benefits for employees and family.
  • Retirement benefits, including 401(k).
  • Paid holidays, vacation, and compassionate and sick days.
  • Annual bonus and long-term incentive, if applicable.
  • Domestic relocation.
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