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SENIOR MANAGER, QUALITY CONTROL - COMPLIANCE

  • Location: South San Francisco
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted about 1 month ago

  • Sector: Life Sciences
  • Contact: Summer Martinez
  • Expiry Date: 02 October 2022
  • Job Ref: JN -082022-473430

SENIOR MANAGER, QUALITY CONTROL - COMPLIANCE

San Carlo, CA

We are looking for an experienced, energic, and dynamic Senior Manager of Quality Control Compliance to support and implement phase-appropriate QC specifications setting, product expiry dating, reference standard and critical reagents, SOPs and other document writing supporting our custom reagents, intermediates, and DS/DP manufactured internally and externally. The successful candidate will have a both a technical understanding of analytical and microbiological test methods, method transfers, and data trending, and an understanding of quality systems, compliance, and regulatory (global). Excellent verbal and written communication skills, time management skills, and critical thinking skills are essential. This role directly interfaces with internal and external Quality Assurance, Analytical Development teams, and external partners.

Responsibilities:

  • Development and implementation of phase-appropriate specifications, stability, product-expiries, reference standard and critical reagents programs to support internal and external manufacturing for globally filed products
  • Provide subject matter expertise for QC methods such as HPLC, CE, IEF, ELISA, bioburden, endotoxin and compendial methods required for the release and stability testing of raw material, in-process, and final product; experience with antibody, antibody-drug conjugates, and small molecules is highly preferred
  • Prepare and review QC documents (protocols, reports, SOPs, special studies, etc.) to support QC analytical and microbiology laboratory operations
  • Support deviation/OOS investigations as it relates to analytical QC testing
  • Work closely within QC and cross-functionally representing QC with QA, Manufacturing, and tech transfer departments to ensure project timelines are met
  • Maintain high quality and compliance standards while representing us with external partners
  • Author and review regulatory documents for us and our partners
  • Provide support during inspections and regulatory audits
  • Proactively identify and troubleshoot issues to prevent missed timelines and identify opportunities for improvement in QC analytical laboratory operations
  • Establish credibility as the SME for all QC issues inside and outside the organization
  • Ensure adherence to GMPs, GLPs, GCPs, and GDPs

Qualifications:

  • BS or MS in Chemistry, Biochemistry, Pharmaceutical Sciences or related field
  • 10+ years with BS or 8+ years with MS in QC experience in a cGMP biologics regulated manufacturing environment is required
  • Working knowledge of antibody, antibody drug conjugates and protein analytical methods is strongly preferred
  • Knowledge in ICH/USP/EP/JP guidelines as it relates to QC methods, validation, stability, reference standards, specifications, and expiry dating
  • Experience managing QC activities at CMOs and CTOs, including method transfers, at all clinical stages is preferred
  • Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
  • Strong interpersonal skills and ability to work with others in a positive "can do" and collaborative manner
  • Previous experience with statistical tools such as JMP is preferred
  • Excellent customer facing capabilities
  • Strong verbal and written communication skills essential



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