Senior GxP Operations Manager

3 weeks ago


Cambridge, Massachusetts, United States Ipsen Pharma Full time

Job Summary


We are seeking a highly experienced Senior GxP Operations Manager to join our Quality Assurance team at Ipsen Biopharmaceuticals Inc. This role will be responsible for managing local Training programs, documentation management, and quality events, ensuring compliance with regulatory requirements and company policies.



Responsibilities

  • Develop and implement GxP Quality programs, ensuring adherence to regulatory requirements and company policies.
  • Manage local Training programs for GxP employees, including curriculum development and delivery.
  • Lead the documentation management process, including revision and life-cycle management of GxP procedures, policies, and work instructions.
  • Serve as the main contact for Product Complaints review, impact assessment, and responses, as well as Temperature Excursions, product replacement requests, and quality inquiries.
  • Communicate and manage quality events, such as deviations, corrective and preventative actions, and change controls.
  • Maintain and report on KPI metrics, ensuring data-driven decision-making.
  • Develop and maintain Quality Technical Agreements as needed.
  • Assist in internal and external audits, as well as host inspections or audits by regulatory authorities and Ipsen Global Quality Audit function.
  • Alert management to potential product risks and establish relationships with local GxP teams.
  • Support new product launches and integration of acquired assets.

Requirements

  • Bachelor's degree or higher in a science-related area.
  • 5+ years of relevant experience executing, developing, and/or administering GxP Quality programs in a pharmaceutical and/or biotech environment.
  • Experience in writing, reviewing, and implementing SOPs and quality systems.
  • Experience in GxP Training management and eQMS electronic platforms for quality systems management and training.
  • Fluency in English.
  • Strong knowledge of US FDA GVP, GDP, and GxP regulations.
  • Highly organized and detail-oriented, with strong communication and collaboration skills.
  • Proficiency in Microsoft Office suite, including Word, Excel, and PowerPoint.

What We Offer

  • Estimated annual base salary range: $109,800 - $134,200.
  • Opportunity to participate in our short-term incentives program.
  • Comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
  • Flexible work arrangements, including up to 10% travel required for this role.

Ipsen is an equal opportunity employer


We welcome applicants from diverse backgrounds and are committed to creating an inclusive work environment.



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