Bristol-Myers Squibb Company


Devens, MA, US
May 12, 2018
Required Education
Bachelors Degree
Position Type
Full time
Provide quality oversight of the site investigations and CAPA programs and provide supervision of personnel approving investigations, change controls, protocols and reports.

  • Manages and executes operating procedures for the site quality assurance program for the investigation and resolution of deviations, CAPA, and complaints.
  • Provides direct supervision of personnel approving investigations, change controls, protocols and reports in support of the manufacturing process.
  • Performs review and approval of site and department SOPs.
  • Develop and manage the training curriculum of direct reports as it relates to investigations, CAPA, change controls, protocols and reports.
  • Provide oversight of Investigations/CAPA management and tracking to ensure timely and compliant closure
  • Contributes to and supports the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products
  • Directly participates in internal audits or reviews as well as global health authority inspections
  • Hires, integrates and develops high quality talent, capable of delivering against the department goals and objectives
  • Establish and communicates performance objectives for Quality Assurance staff that are consistent with the company goals and objectives
  • Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment enhances unit performance and integration across site departments
  • Provides oversight to identify and implement changes that lead to realization of long-term department goals.

  • Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is required
  • A minimum of 8 years' experience in biopharmaceutical operations with 2 years of prior management experience desirable
  • Experience in building and growing an organization into a high performance team.
  • Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics manufacturing with direct accountability for final product release.
  • Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable.
  • Knowledge of US and EU cGMP regulations and guidance.
  • Knowledge and proven experience in FDA, EMA, or other regulatory authority.
  • Demonstrated leadership, interpersonal, communication, and motivation skills.
  • Knowledge of applicable business systems including: SAP, LIMS, Maximo and Trackwise.
  • Knowledge of manufacturing executions systems such as Syncade, SmartLab; and distributive control systems such as DeltaV is desirable