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Vice President, Quality

Cambridge, MA 02139

Posted: 10/19/2018 Job Category: Clinical: Quality Job Number: 2077

Reporting to the Senior Vice President, Regulatory Affairs & Quality, you will lead Client' s growing Quality Systems team and will be responsible for developing and driving the group’ s strategy and operations in support of active pipeline and business needs. With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, company is entering one of the most exciting periods in its history. This will be a time of dynamic growth, requiring timely, strategic decision making to inform, motivate, and energize internal and external stakeholders.

Job Responsibilities:
  • Oversee Quality Assurance and Quality Control functions across all GXP processes. Company operates an in-house GMP drug substance manufacturing facility for therapeutic proteins. Though GMP compliance is a large part of the job function, the VP Quality Systems will be responsible for overseeing GCP and GLP requirements across the company
  • Interact with regulatory agencies in regard to GXP matters
  • Oversee the systems and procedures that ensure compliance with ICH guidelines and national Health Authority regulations
  • Work to improve our current quality management systems and to establish Strategic Quality Objectives in support of development programs and Company goals
  • Develop/maintain internal and external audit programs to satisfy contractual and regulatory requirements for GXP
  • Coordinate the Quality review of documents for regulatory submissions
  • Oversee pre-approval inspection readiness for lead program approaching co-commercialization (with development partner), and lead efforts to prepare for commercialization of wholly-owned assets
  • Develop and review validation and qualification plans and reports
  • Optimize Quality Systems processes, including electronic deployments for CAPA, Change Control, Document Control, Risk Management, identification of Critical Quality Events, etc.
  • Establish adequate GMP, GCP and GLP training programs for the Company to support aggressive growth plan
  • Manage and develop Quality Systems staff


Qualifications
  • Bachelor' s Degree is required (Biological sciences, engineering or related degree); advanced degree a is a plus
  • 15+ years of experience in Biotech/Pharma, with at least 5-10 years in a supervisory capacity
  • Hands-on leader capable of performing lot release, data review, laboratory and facility audits
  • Experienced in all phases of protein drug development
  • Full range of QA experience preferred in GMP, GCP and GLP
  • Knowledge of current GXP qualification and validation expectations
  • Experience with European quality guidance and Qualified Persons (QP) requirements
  • Project management and program set-up experience highly desirable, including interactions with corporate partners and collaborators
  • Practical knowledge of implementation of ICH Q10 Quality Systems, especially Risk Analysis/Management, CAPA, Annual Product Reviews and Management Review and Supplier Quality Management
  • Excellent leadership and management experience with the ability to lead a team of approximately 15 employees (currently)
  • Excellent team player and communicator
  • Ability to demonstrate flexibility in the face of shifting priorities or unexpected occurrences in development
  • Ability to interface well with all levels of personnel, including peers and other department heads such as: Manufacturing, QC, Clinical, Regulatory and Project Management
  • Strong communication skills (technical writing and verbal)
  • Electronic Quality Systems experience with implementation and validation
  • Capacity to produce high quality results across multiple projects and prioritize demands while working under short deadlines associated with a fast-paced, dynamic, scientific environment

Demeika Roberts

Demeika is known for her enthusiasm in working closely with hiring managers to assess their needs, creatively solve problems, and passionately help candidates find their “perfect fit” dream jobs.

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