Director GMP, Neurology, Pharmaceuticals

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Irfa******

  • United States 
  • Last Update: 18.07.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
6 Month +
Place
Greater Boston Area
Country
United States

Category


General Administrative

Description


Job description

Overview

Great opportunity to join a pre- IPO pharmaceutical company. Looking for someone who will be responsible for strategic and operational management of the GMP and GLP QA activities. This role will have responsibility for providing QA oversight of GMP activities and its contract development and manufacturing organizations (CDMOs).

This individual will provide technical quality expertise in the development and implementation of cGMP compliant quality systems, to ensure product quality, data integrity and most importantly, patient safety. This is a growth opportunity to define the GMP QA function at Cerevel to deliver high quality products in the clinical and commercial settings.

In addition, this role will work closely with the GCP Quality function to develop Global Quality operations, which are inclusive of GxP SOP Management, CAPA and Deviation Management, product complaints, SOP and Quality-related training and Document Management.

Keys to this position are a hands on approach and willingness to grow into managing a team. They are looking for team players who want to work collaboratively and enjoy the challenges of a smaller company.

Responsibilities:
  • Capable of leading the team providing QA oversight for GMP/GLP activities and its contract development and manufacturing organizations (CDMOs).
  • Ability to develop and implement risk-based Quality strategies for clinical and commercial products
  • Proactively work with GCP Quality and Technical Operations staff to identify and mitigate quality risks within the company
  • Develop processes for quality related requirements to enable the release and disposition of clinical and commercial products
  • Develop, implement and maintenance of GMP/GLP Quality systems and procedures
  • Ensure appropriate training of staff on GMP/GLP regulations and guidances
  • Responsible for the auditing of CDMOs, providing recommendations and following up on corrective actions
  • Provide Quality oversight to clinical and commercial distribution activities
  • Lead preparations for CDMO inspection readiness
  • Lead investigations and develop appropriate plans to resolve product related Quality issues including oversight of CAPAs, investigations, deviations, product complaints and recalls
  • Develop metrics for GMP Quality and CDMOs and report results to senior management
  • Ensure Technical Operations and CDMOs are compliant with global regulations, guidelines and industry standards
  • Additional responsibilities as needed by a growing organization

Mandatory Requirements:
  • Bachelor

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