QA Operations Manager - Laboratory Services

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

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