Senior Manager / Associate Director, GMP Quality Assurance

San Diego, CA

  • We are seeking a responsible, dynamic, creative and highly motivated Senior Manager or Associate Director, GMP Quality Assurance to join our Quality Assurance department.  
  • This role is responsible for providing quality oversight and managing the quality aspects of clinical drug substance/drug product manufacturing at contract services providers (CSP) and will support internal CMC functions to ensure GMP compliance. 
  • This is a full-time position in the company’s San Diego headquarters. 
  • The title will be dependent upon experience level

Specific Responsibilities

  • Work directly with internal teams and CSPs to ensure drug substance and drug products meet required quality standards and specifications.
  • Review manufacturing and labeling batch records and perform lot disposition activities in collaboration with CMC department to ensure ongoing clinical drug supply.
  • Plan and lead GMP compliance audits (internal and CSPs).
  • Develop and review Quality Agreements with CSPs and external parties, as needed.
  • Provide quality assurance support for supplier qualification, technology transfer, scale-up, validation and other cGMP activities.
  • Maintain quality systems processes and procedures: change control, compliance audit, quality investigations (i.e., deviations and OOS), supplier qualification and management, training, complaints, and CAPA; implement process improvements to ensure cGMP compliance.
  • Perform QA review and approval for GMP SOPs; author new procedures and revisions as needed.
  • Review and approve Production Records, Specifications, Test Methods, Validation Protocols, Stability Protocols/Reports, and other cGMP documentation.
  • Facilitate resolution of quality issues with internal and external parties in a timely manner. Coordinate communications with CSPs and internal team for quality issues.
  • Perform QA review of CMC sections of regulatory submissions.
  • Work effectively and collaboratively with external vendors and cross-functional teams, such as pharmaceutical development, CMC, clinical, regulatory affairs, and program management
  • Assist with regulatory inspection readiness activities.
  • Ensure that documents and records are kept in compliance with regulations and internal procedures

Requirements

  • BA/BS in a scientific field of study
  • At least 10 years of relevant experience in GMP quality assurance
  • Experience managing quality systems
  • Experience with preparation of CMC sections of US/EU regulatory submissions
  • 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
  • Experience with contract service provider oversight and conducting audits
  • 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 apply@samumed.com. 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. NO PHONE CALLS PLEASE.