Project Manager

Join a Leader in Pharmaceutical Innovation

Are you passionate about leading projects that can transform lives through innovative treatments? By becoming part of this esteemed organization, you have the opportunity to make a significant impact in the pharmaceutical industry.

Your Role

In this pivotal position, you will bring your quality assurance expertise in medical devices and combination products to the forefront. You will lead complex projects, providing strategic guidance and support to global teams, while ensuring compliance with regulatory standards and driving the quality of project deliverables.

Responsibilities

• Lead and support global project teams, representing quality assurance in sub-teams, quality board meetings, and development gate meetings.
• Provide quality oversight on assigned development projects, offering strong guidance and technical expertise.
• Develop and implement project strategies, including contingency planning and risk assessments to ensure the timely delivery of quality outcomes.
• Ensure alignment of project strategies with quality assurance goals, while adhering to current Good Manufacturing Practice (cGMP) guidelines and internal procedures.
• Manage interactions between quality assurance and other departments, both internally and externally.
• Communicate project strategies, key issues, and critical updates to stakeholders and management in a timely manner.
• Contribute to contracts and quality assurance agreements with third parties, approving project-specific amendments as needed.
• Lead or participate in global and cross-functional initiatives.
• Prepare and guide project teams for inspections, including Mock-Pre-Approval Inspections (PAI) and PAI, as part of submission preparation processes.

Key Skills and Requirements

• Strong understanding of quality standards and policies in drug product and medical device/combination product manufacturing and control.
• Experience with Health Authority inspections (e.g., FDA, EMA) and Notified Body inspections.
• Knowledge of regulatory requirements for submissions (e.g., INDs, IMPDs, NDAs, ANDAs, MAAs).
• Proven experience in combination product development and quality assurance or quality control.
• Familiarity with technical operations or equivalent experience in external companies.
• Demonstrated ability to support interdisciplinary teams and contribute to matrix teams with strategic thinking and quality awareness.
• Proficiency in computer systems, including MS Office and document management systems, with a willingness to learn new tools.
• Fluent in English (oral and written); proficiency in additional languages is a plus.

Be a part of an organization that excels in connecting exceptional talent with premier opportunities in the life sciences sector. Embrace the chance to contribute your expertise and take a meaningful step in your career journey.