Adverum Biotechnologies
Associate Director of External QA (Finished Goods) (Contract)
All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered Adverum's property. Adverum’s Talent Acquisition team must expressly engage agencies for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.
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 commercial multi-regional regulatory requirements, as well as corporate quality objectives. The candidate will have demonstrated successful experience in Quality oversight of external manufacturing operations, including the representation of cross-functional requirements from Regulatory, Quality Control, Development, Project Management, and Manufacturing.
The individual must provide strategic leadership within internal and external CMC functions, along with cross-functional leadership at Eli Lilly. This includes the ability to work independently and also as an effective and engaged 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 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.
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