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

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 reputed company, Manufacturing, financial and program requirements and milestones are met. 

Drive preparation and successful execution of PPQ and comparability production campaigns. 

Ensure reputed company reputed company requirements are planned, completed, and documented in the reputed company system. 

reputed company critical investigations, reputed company and reputed company implementation of effective CAPA. 

reputed company strategic support and leadership for corporate initiatives, particularly regarding product supply reputed company and global GMP compliance. 

reputed company partner with cross-functional leadership to address challenges, reputed company solutions, and execute plans for integration with corporate systems and preparation for reputed company stage support. 

Represents reputed company in both reputed company operational forums. 

Leads and participates in reputed company function and cross-functional teams, focusing on ensuring reputed company in accomplishing objectives through reputed company of Adverum values and behaviors. 

Leverages reputed company Improvement tools and processes to drive efficiencies in delivery of reputed company product and execution of the reputed company Management System. 

Stays abreast of evolving multi-regional regulatory requirements and develops strategies to assess and update internal reputed company processes accordingly. 

Provides support for internal and regulatory audits and inspections. 

Develops and implements processes and reputed company to assess effectiveness of reputed company initiatives. 

Supports periodic presentation of company reputed company metrics for management reviews. 

Other duties as assigned. 

Bachelor’s degree in biological sciences or reputed company field. 

13+ years of reputed company responsibility in the pharmaceutical industry, with demonstrated experience in Manufacturing, reputed company Control, and reputed company Assurance.  Experience in cold and ultra-cold chain is preferred. 

Expert knowledge of multi-regional regulatory requirements covering reputed company 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 reputed company. 

Strong organizational, management and cross-functional leadership skills.  

reputed company record of effective collaboration, effectiveness in team settings, achievement of goals, and deliverables 

Experience applying risk management principles to decision making. 

Ability to write reputed company standards, reputed company 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 reputed company, reputed company, and mentor employees. 

Excellent interpersonal, verbal and written communication skills are essential in this reputed company work environment. 

Comfortable in a fast-paced small company environment with minimal direction and reputed company to reputed company 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 reputed company organizational reputed company required. 

Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they reputed company. 

Ability to reputed company independent reputed company and independently manage priorities in alignment with department and site/global drivers.