Jul 15, 2020

Head Gene Therapy, Global External Quality (Senior Manager/Associate Director)

  • Professional Diversity Network
  • Cambridge, MA, USA
Information Technology (IT)

Job Description

Biogen

Job DescriptionThis person is responsible for managing the team responsible for quality operations and interface with manufacturing and testing partners for early to late phase Gene Therapies.This person will manage the team responsible for onboarding gene therapy assets and executing transactional activities related to quality operations and CMO management. This person will contribute to developing quality and CMC strategies for the development assets in emerging technologies. Core responsibilities include but are not limited to: product / process transfers, scaleup / validations, product disposition, exceptions (deviation, CAPA), change control and risk management.This person will manage the team responsible for:Onboarding gene therapy assets and executing transactional activities related to quality operations and CMO management.Product / process transfers, scaleup / validations, product disposition, exceptions (deviation, CAPA), change control and risk management.May also lead and/or support continuous improvement initiatives related to Biogen's QMS and procedures for CMO and partner oversight.Collaborates with internal and external functions such as External Manufacturing Operations, Clinical Supply Chain, Label Development, Planning & Logistics, Regulatory Affairs, Product Development Quality and Technical Development to ensure compliance with cGMP regulations and Biogen QMS.Success in the role requires a strong knowledge in the application of phase appropriate, risk-based quality principles.Success in this role also requires an ability to develop strong relationships with internal and external counterparts, possess effective interpersonal, strong verbal and written communications skills, and a collaborative spirit and ability to think outside of the box to influence and drive continuous improvement efforts.Must be comfortable working in a fast-paced environment with minimal direction and ability to deal with ambiguity and changing priorities.Strong ability to effectively manage and develop direct reports and a proven record of delivering on quality metrics to ensure uninterrupted supply of product.QualificationsAssociate DirectorMinimum of 12 years pharmaceutical quality manufacturing, packaging, or laboratory experience including at least 5 years in clinical quality operations (gene therapy preferred) and vendor managementStrong working knowledge of modality specific unit operations (Vector/Plasmids manufacture / Cell Bank manufacture / Drug Substance / Aseptic Fill Finish operations) with the ability to influence and implement quality strategy.Ability to develop new business relationships, and to nurture partnerships with internal and external stakeholders.Ability to provide strong cross-functional team leadership, in order to maintain alignment and to set and meet collaborative operational goals.Prior working experience in setting quality strategies for CMC considerations and quality operationsComprehensive knowledge of international GMP and GDP regulations and subsequent applications to pharmaceutical drug product manufacturing.Excellent written and verbal communicator with ability to facilitate/articulate recommendations and key decision points to senior management.Demonstrated experience in driving and implementing improvement strategies for External Quality and Supply Chain processes and systemsGood understanding of CMO mediated Supply Chain activities including process, technology transfer, and routine operationsExperience in contributing to regulatory filings and inspections a bonusExperience in people management (>5 years) and project management is a plusMinimum, an Associates degree in life sciences, engineering or related field with 12+ years industry experience, BS, MS is preferredOR: Senior Manager Minimum of 10 years pharmaceutical quality manufacturing, packaging, or laboratory experience including at least 5 years in clinical quality operations (gene therapy preferred) and vendor managementStrong working knowledge of modality specific unit operations (Vector/Plasmids manufacture / Cell Bank manufacture / Drug Substance / Aseptic Fill Finish operations).Ability to develop new business relationships, and to nurture partnerships with internal and external stakeholders.Ability to provide strong cross-functional team leadership, in order to maintain alignment and to set and meet collaborative operational goals.Comprehensive knowledge of international GMP and GDP regulations and subsequent applications to pharmaceutical drug product manufacturing.Excellent written and verbal communicator with ability to facilitate/articulate recommendations and key decision points to senior management.Ability to drive and implement improvement strategies for External Quality and Supply Chain processes and systemsGood understanding of CMO mediated Supply Chain activities including process, technology transfer, and routine operationsExperience in contributing to regulatory filings and inspections a bonusExperience in people management (>2 year) and project management is a plusMinimum, an Associates degree in life sciences, engineering or related field with 10+ years industry experience, BS, MS is preferredAdditional InformationThis person is responsible for managing the team responsible for quality operations and interface with manufacturing and testing partners for early to late phase Gene Therapies.PDN-84b3e7ee-7f1c-479c-9d0b-94431a9ea798

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