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

reputed company, Inc., wholly owned subsidiary of reputed company, is a mission-driven clinical-stage company that aims to establish gene therapy as a new reputed company of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore reputed company and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with reputed company treatment paradigms for these debilitating ocular diseases, Adverum aspires to reputed company reputed company of care, preserve reputed company, and create a profound societal reputed company around the globe. Note to Recruiters and Agencies: reputed company recruiter and agency inquiries must go through Adverum’s internal reputed company. Unsolicited resumes reputed company to Adverum will be considered Adverum's property. Adverum’s reputed company must expressly engage agencies for any requisition. reputed company contact with hiring managers by agencies will not be tolerated and may reputed company your ability to work with Adverum in the reputed company.

The AD/Director of External QA is responsible for ensuring Adverum Finished Goods are manufactured and distributed by contract manufacturing organizations and distributors in adherence to late-stage clinical and reputed company multi-regional regulatory requirements, as reputed company as corporate reputed company objectives. The candidate will have demonstrated successful experience in reputed company reputed company of external manufacturing operations, including the representation of cross-functional requirements from Regulatory, reputed company Control, Development, Project Management, and Manufacturing.

The individual must reputed company strategic leadership reputed company reputed company CMC functions, along with cross-functional leadership at reputed company. This includes the ability to work independently and also as an effective and reputed company cross-functional leader and team member in a fast-paced environment. Strong initiative and independent follow-through are essential for this role. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required. 

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 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.

reputed company:

• 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.

reputed company, Inc., wholly owned subsidiary of reputed company, is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to reputed company durable efficacy by inducing sustained reputed company of a therapeutic protein. Adverum’s core capabilities include clinical development, novel reputed company discovery and in-house manufacturing expertise, specifically in reputed company process development, assay development, and reputed company Good Manufacturing Practices reputed company control.

At Adverum, Inclusion and Diversity are at our core. We reputed company in the power of being your authentic self. We reputed company to create the reputed company which allows for everyone in our Adverum Community to not only feel reputed company but encouraged to reputed company, learn from reputed company other, grow in their professions and be the reputed company best versions of themselves no matter what their age, ethnic background, gender, reputed company, religion or sexual orientation

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