Director of Quality

Our Manufacturing and Process Sciences group is seeking a Director of Quality.  In this role, you will establish a Quality Assurance group to develop, implement, and maintain the company’s CMC quality assurance program to ensure regulatory compliance of all internal GMP functions and external GMP vendors (CMOs, CROs). The successful candidate will also build a Quality Control group to provide leadership, plan, direct, and coordinate in-process testing, finished product release testing and stability programs. This position reports to the VP of Process Sciences and Manufacturing.

Qualifications:

  • Bachelor of Science degree in the Life Sciences/Engineering, or equivalent
  • Minimum 15 years of experience in the Pharmaceutical/Biotech industry or an equivalent combination of education and experience
  • Minimum of 5 years management experience of exempt and non-exempt employees in the Quality Management setting
  • Working knowledge of FDA/EMA cGMP regulations including 21 CFR 210, 211, 820 and ICH guidelines
  • Experience with regulatory inspections, including FDA, EMA and Ministries of Health
  • Experience providing scientific input, data analysis and written reports for failure investigations
  • Practical knowledge and sound understanding of methods development, validation and regulatory submission
  • Effective oral, written, and interpersonal communication skills
  • Must be able to commute to Mountain View

Responsibilities:

  • Build a Quality organization supporting both Quality Assurance and Quality Control with requisite budget and resources to support company’s eventual product commercialization
  • Develop and implement company Quality Systems to ensure compliance with cGMPs and US & EMA regulations, including design control, document control, change control, nonconforming product, manufacturing and production, and CAPA
  • Provide Quality oversight to all cGMP activities, including Drug Substance and Drug product manufacturing, secondary packaging and assembly, and clinical packaging operations
  • Manage and support all quality activities related to the manufacturing and release of clinical product including resolution of investigations and quality issues
  • Responsible for ensuring that all drug substances and drug products are manufactured in accordance with IGM’s specifications, in compliance with cGMP and consistent with applicable regulatory filings
  • Provide quality oversight, review and approve analytical, manufacturing, stability and validation documents including batch records, protocols, procedures, methods, data and final reports
  • Approve and issue specifications, and methods for drug substances and products
  • Conduct risk and gap analyses of existing systems and processes
  • Oversee qualification, performance tracking, and reviews of contract manufacturers, suppliers and laboratories and manage internal and external audits
  • Manages quality investigations at contract manufacturers to ensure that all critical and major quality issues are thoroughly investigated with appropriate corrective actions
  • Review and approve IQ/OQ/PQ and validation protocols, tech transfers and reports, as applicable, for all manufacturing, testing, and packaging activities at all CMO’s
  • Maintain Quality Agreements, and all quality associated documentation files, databases, and logs
  • Responsible for developing and maintaining QC policies and ensure quality and compliance in the QC laboratory
  • Provide effective leadership including setting individual and department objectives, employee evaluations, leading departmental meetings, providing performance feedback, recognizing employee contributions, coaching and developing staff
  • Provide guidance and risk assessment for the resolution of discrepancies, OOS, unexpected results, lab investigations and Corrective and Preventative Actions
  • Oversee all aspects relating to the QC instrumentation program including; purchase, installation, qualification, PM scheduling and trouble shooting
  • Routinely interacts with internal and external colleagues, regulatory agencies, and internal auditors/inspectors

Must be able to travel ~10% of the time.

IGM is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. All qualified applicants will receive consideration for employment.

 
 
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Posted in Manufacturing & Process Sciences.