MANAGER, QA TECHNICAL OPERATIONS
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