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Merck

Makes medicines, vaccines and animal treatments

Director – Lead - US Quality, Analytical Technical Solutions

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A bachelor's degree in analytical, pharmaceutical, biopharmaceutical, biological, analytical science, or equivalent job experience is required; a master's degree is preferred.
  • At least 10 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, validation, robustness, and transfer.
  • In-depth experience and a proven track record shaping, developing, and leading multiple teams and employees in matrix organizations.
  • A strong background in project execution and demonstrated leadership skills.
  • Skill in leading and driving multifaceted projects in a complex environment.
  • Communication, networking, and behavioral skills aligned with the position requirements.
  • 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, current Good Manufacturing Practice compliance, decision-making, driving continuous improvement, execution excellence, people leadership, pharmaceutical quality control, stakeholder management, and technology transfer.
  • A valid driving license is required.

Responsibilities

  • Manage, plan, shape, and develop the organization.
  • Plan organizational needs and capabilities to meet business requirements in alignment with partners and the lead.
  • Plan staffing and the team's budget.
  • Select and hire team members.
  • Set reporting structures and team governance.
  • Develop and coach team members where needed.
  • Coordinate project execution, cross-functional alignment, metrics, and reporting for the analytical project portfolio.
  • Set targets, deliver milestones, and report progress in tier and governance meetings.
  • Monitor the quality and timeliness of delivered progress.
  • Identify critical gaps and needs within the portfolio to enable strategy achievement.
  • Mitigate issues and drive their resolution when necessary.
  • Act as a clear and visible point of contact for partners and customers on analytical topics.
  • Understand colleagues' business priorities and needs.
  • Manage expectations and provide transparency regarding work prioritization and timelines.
  • Represent the team and its progress in senior leader meetings and recommend direction.
  • Gather and translate the voice of the customer into actionable insights to enhance 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.
  • Ensure team priorities align with local site management, quality operations, and regional heads at regional sites.
  • Own, oversee, and report analytical activities undertaken by the team.
  • Plan and execute regional company strategy as part of an integrated team.

Desired Qualifications

  • Regulatory compliance.

About the Company

Merck

Makes medicines, vaccines and animal treatments

Merck develops prescription medicines, vaccines and veterinary treatments for patients, health systems and animal owners worldwide. Its vaccine portfolio includes Gardasil 9, which helps prevent cancers and other diseases caused by several types of human papillomavirus. The company takes potential treatments through laboratory research and clinical trials, then manufactures and sells approved products to drug distributors, hospitals, physicians and governments. Its animal health division sells medicines and vaccines to veterinarians, farmers and pet owners, while selected drug partnerships also earn shared profits or royalties. Founded in 1891, Merck is headquartered in Rahway, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Rahway, NJ
Founded
1891

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