Bristol-Myers Squibb Company

QA Operations Manager - Laboratory Services

Location
Devens, MA, US
Posted
Oct 08, 2018
Ref
R1508709
Required Education
Bachelors Degree
Position Type
Full time
QA Operations Manager - Laboratory Services

Major Duties and Responsibilities
  • Manages and executes operating procedures for the site quality assurance program for the investigation and resolution of laboratory deviations and CAPA
  • Manages and executes site practices and procedures related to laboratory instrument qualification, usage, and method execution and trending, ensuring compliance with internal and external expectations
  • Provides support and direct supervision of personnel approving investigations, change controls, protocols and reports in support of laboratory and analytical processes.
  • Develops and manages the training curriculum of direct reports as it relates to investigations, CAPA, change controls, protocols and reports.
  • Reviews and approves discrepancy reporting, investigations and CAPAs associated with all areas of laboratory operations including incoming, in-process, release, and stability testing.
  • 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. Hires, integrates and develops high quality talent, capable of delivering against the department's goals and objectives.
  • Establish and communicates performance objectives for Quality Assurance staff that are consistent with the businesses unit goals and Quality and site objectives.
  • Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that enhances unit performance and integration across site departments.


Knowledge and Skills

  • 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
  • Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial Quality laboratory operations
  • Strong background and demonstrated effectiveness in quality assurance operation and compliance of clinical/commercial biologics manufacturing is desired
  • Knowledge of US, EU and rest-of-world cGMP regulations and guidance
  • Knowledge and proven experience in FDA, EMA, or other regulatory authority.
  • Knowledge of applicable business systems including: SAP, LIMS, Maximo and Trackwise is required
  • Knowledge of manufacturing executions systems such as Syncade, SmartLab; and distributive control systems such as DeltaV is desirable
  • Experience in building and growing an organization into a high performance team
  • Demonstrated leadership, interpersonal, communication, and motivation skills
  • Excellent writing and oral communication skills are required
  • Previous work responsibility, which required a high degree of attention to detail
  • Well practiced in exercising sound judgment in decision-making
  • Demonstrated prioritization and organization skills