Associate Director of External QA (Finished Goods) (Contract)

What you'll do:

• 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. 

About you:

• 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.