Associate Director, External Quality Assurance – Contract

Role Overview

• 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.

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 cell culture and viral vector manufacturing platforms 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.

Benefits

• Health insurance
• Professional development