Job Description

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Title: Senior Manager, QA Operations

Location: The position will be remote, with a preference of CA residency .

Travel: Up to 25% travel may be necessary in order to effectively oversee CDMO’s

POSITION SUMMARY

Senior Manager, QA Operations.

• In this role you will be responsible for Quality Assurance oversight of one or several Contract Development and Manufacturing Organizations (CDMO) in charge of development and manufacturing of drug substance products.
  
• The role will be involved during all steps of the CDMO life cycle: qualification and selection, technology transfer, management and decommission.
  
• The Senior Manager, QA Operations will be responsible for providing quality oversight and decision making regarding the starting material (SM) and drug substance (DS) development and manufacturing at the CDMO.
  
• This includes cell line development, master cell banking, toxicology batch manufacturing, analytical method verification/qualification/validation, and clinical drug substance product batch manufacturing and testing.
  ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
  
  
  • Oversee all the CDMO’s subcontracted activities from a quality perspective such as cell banking, reference standard, stability program, process development, manufacturing and testing operations.
    
  • Responsible for all quality-related matters related to manufacturing, testing and release at CDMO
    
  • Responsible and accountable for CDMOs quality management activities including deviations, change management, CAPAs, complaints, and batch release.
    
  • Independently complete quality activities such as writing and review of SOPs, CDMO batch records, analytical methods, CoA release/stability data, process and method qualification/validation documents, specifications, label proofs, technical protocols, reports, including source data verification.
    
  • Work with CDMOs and internal functional colleagues to facilitate resolution of quality issues and ensure that products meet all required quality standards and specifications.
    
  • Provide quality guidance and support to key stakeholder groups (Process Development, Quality Control, Analytical Development, Supply Chain, Manufacturing) for the qualification and selection of CDMOs, technology transfer, qualification, and management of CDMOs.
    
  • Negotiate and maintain quality agreements between the company and CDMOs
    
  • Support quality review of CMC modules of regulatory submissions as needed
    
  • Represent Quality for analytical / process development and technical transfers to/from CDMOs
    
  • Define, monitor, and report quality performance metrics utilizing data analysis and trending tools, as applicable.
    
  • Ensure implementation of quality initiatives, data integrity and continuous process activities, as applicable.
    
  • Perform quality risk assessments, develop mitigation plans, and follow up on implementation
    
  • Support the quality management system (QMS) function in the development and maintenance of internal quality system processes and procedures (e.g., training, audit, deviation and change control) that complies with applicable GMP standards, guidelines, and regulations.
    
  • Maintain CDMO site readiness for Health Authority regulatory inspections and for audits
    • Participate in on-site regulatory inspections and client audits
    • Maintain current knowledge of applicable Quality and Regulatory requirements and evolving trends and support the CDMO to meet these standards
    • Other responsibilities as assigned/delegated by management, as appropriate
    EDUCATION AND WORK EXPERIENCE
    
    • Bachelor’s Degree in Chemistry, Biology, Engineering or related field plus 10 years biopharma manufacturing and laboratory experience in the Biopharma/Biotech GMP Environment; or Master’s Degree in Chemistry, Biology, Engineering or related field plus 7 years relevant industry experience in Quality Assurance in the Pharma/Biotech GMP environment
    • Demonstrated experience in supplier/vendor quality management leadership experience in a GMP regulated environment
    • At least 7 years of direct QA/compliance experience working in biotechnology, biopharmaceutical, laboratory, CRO or CDMO environment
    • Comprehensive working knowledge of FDA, ICH and international cGMP regulations, guidelines, and application to drug development
    • In-depth Quality experience in biologics drug substance through the product lifecycle
    • Strong prioritization and problem-solving skills
    • Thorough understanding of creation, review, and approval of GMP documents such as specifications, test methods, stability/validation protocols, batch records, deviations, investigations, change controls, and CAPAs
    • Demonstrated experience working autonomously and on cross functional/global teams
    • Excellent verbal/written communication skills, including knowing when email or conversations are appropriate; Ability to flex communication approach based on needs of others
    • Demonstrated project management skills, excellent attention to detail and organizational skills
    • Capable of analyzing a wide variety of information and data to make decisions regarding potential risks associated with product quality or regulatory compliance
    • Ability to build and maintain professional relationships and rapport with internal and external colleagues
    • Ability to adapt in a fast-paced environment with competing priorities
    • Root Cause Analysis, Investigator and/or Operational Excellence (e.g., Six Sigma, Kaizen qualification) skills are desirable
    • Up to 25% travel may be necessary in order to effectively oversee CDMO’s
    Ref: #568-Clinical

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Contract

Job function

• Job function

  Quality Assurance

• Industries

  Staffing and Recruiting

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Job Tags

Full time, Contract work, Work experience placement, Flexible hours,

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