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Adverum Biotechnologies

Adverum Biotechnologies is a clinical-stage biotechnology company pioneering the development of gene therapies to treat serious ocular diseases. Headquartered in Redwood City, Cali

Associate Director, External QA – Finished Goods

Location

California

Posted

75 days ago

Salary

$100 - $110 / hour

Seniority

Senior

Bachelor Degree13 yrs expEnglish

Job Description

Associate Director, External QA – Finished Goods

Adverum Biotechnologies

• Leads and participates in cross-functional production teams, internally and externally. • Engages, drives, influences, and leads product teams, internal functions, and external partners to ensure Adverum Quality, Manufacturing, financial and program requirements and milestones are met. • Drive preparation and successful execution of PPQ and comparability production campaigns. • Ensure all quality requirements are planned, completed, and documented in the Quality system. • Lead critical investigations, develop and oversee implementation of effective CAPA. • Provide strategic support and leadership for corporate initiatives, particularly regarding product supply integrity and global GMP compliance. • Actively partner with cross-functional leadership to address challenges, develop solutions, and execute plans for integration with corporate systems and preparation for commercial stage support. • Represents Quality in both internal and external operational forums. • Leads and participates in Quality function and cross-functional teams, focusing on ensuring success in accomplishing objectives through practice of Adverum values and behaviors. • Leverages Continuous Improvement tools and processes to drive efficiencies in delivery of quality product and execution of the Quality Management System. • Stays abreast of evolving multi-regional regulatory requirements and develops strategies to assess and update internal quality processes accordingly. • Provides support for internal and regulatory audits and inspections. • Develops and implements processes and criteria to assess effectiveness of quality initiatives. • Supports periodic presentation of company quality metrics for management reviews. • Other duties as assigned.

Job Requirements

  • Bachelor’s degree in biological sciences or related field.
  • 13+ years of progressive responsibility in the pharmaceutical industry, with demonstrated experience in Manufacturing, Quality Control, and Quality Assurance. Experience in cold and ultra-cold chain is preferred.
  • Expert knowledge of multi-regional regulatory requirements covering Quality systems.
  • Ability to read, analyze, and interpret standards, procedures, or governmental regulations/guidance.
  • Demonstrated consistent accuracy and thoroughness. Ability to apply feedback to improve performance. Monitors own work to ensure quality.
  • Strong organizational, management and cross-functional leadership skills.
  • Track record of effective collaboration, effectiveness in team settings, achievement of goals, and deliverables
  • Experience applying risk management principles to decision making.
  • Ability to write quality standards, standard operating procedures, work instructions, reports, etc.
  • Experience with ICH, US and EU Regulatory Requirements.
  • Previous experience presenting and responding to regulatory agency audits.
  • Demonstrated ability to develop, coach, and mentor employees.
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
  • Ability to travel occasionally (US and International).
  • Demonstrate good judgement and escalate important issues to Sr. management; experience and comfort interacting with staff at all organizational levels required.
  • Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise.
  • Ability to make independent sound decisions and independently manage priorities in alignment with department and site/global drivers.

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