Senior Manager / Associate Director, CMC

San Diego, CA

  • We are seeking a responsible, dynamic, creative and highly motivated Senior Manager or Associate Director, CMC to join our Quality Assurance department.
  • This role will provide technical compliance and oversight of contract manufacturing, testing, research, and/or laboratory organizations.
  • This is a full-time position in the company’s San Diego headquarters.
  • The title will be dependent upon experience level. 

Specific Responsibilities

  • Providing quality and compliance oversight of the quality systems at Samumed and those of contract manufacturing, testing, research and/or laboratory organizations including, but not limited to: product complaints, deviations, OOS investigations, document creation and control, site audits, change control, validation (e.g., process, cleaning, analytical method, etc.), stability, batch record review, and product disposition
  • Proactively managing Contract Manufacturing Organizations (CMOs) according to Samumed’s quality standards to support the multi-product portfolio of clinical development programs
  • Providing technical expertise and guidance to CMOs by supporting or managing deviations, investigations, changes, risk assessments and CAPAs
  • Working effectively and collaboratively with external vendors and cross-functional teams, such as pharmaceutical development, manufacturing, quality control, regulatory affairs, and program management
  • Providing guidance functionally and cross-functionally; managing work activities of peers and contractors for specific projects or objectives as required
  • Managing batch disposition activities to ensure that products are dispositioned in accordance with cGMP, Samumed policies and procedures, and project timelines.  Communicating any delays or significant quality issues in a timely manner. Addressing any lot disposition documentation requests in support of clinical trials
  • Partnering with CMO quality organizations to ensure timely and appropriate batch disposition.
  • Supporting the development, implementation and maintenance of quality systems to maintain oversight of CMOs, CROs and contract labs, including but not limited to; document control, change control, investigations, deviations, CAPA, and product/customer complaints. Writing and/or reviewing associated SOPs, forms, and templates
  • Providing support for quality audits at CMOs including the implementation and monitoring of audit related CAPAs
  • Participating in the review, evaluation and approval of contract manufacturing, testing, research and/or laboratory facilities
  • Reviewing and approving GMP-related documents as requested and appropriate
  • Ensuring that documents and records are kept in compliance with regulations and SOPs


  • BA/BS in a scientific field of study
  • At least 10 years of relevant experience in manufacturing and or quality assurance
  • Sound knowledge of the drug development process
  • In depth understanding and application of industry standards and cGMP/international regulations and guidelines
  • Risk assessment experience and understanding of risk management principles. Familiarity with risk based approaches suitable for bio-pharmaceutical development
  • Advanced ability to define problems, collect data, establish facts, and draw valid conclusions
  • Ability to successfully manage a full workload across multiple-projects
  • Ability to manage vendor compliance
  • A flexible attitude with respect to work assignments and continued industry related education
  • Must have ability to innovate, think strategically and conceptually, and manage multiple projects simultaneously
  • Ability to handle even difficult situations professionally and maintain a professional and caring demeanor

Please submit your resume or additional inquiries to Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded.